Arraylist Methods Jobs in Usa

Provide the foundation on which Planned Parenthood of Metropolitan Washington DC, Inc. (PPMW) builds efficient, professional health centers. As the initial point of contact with clients and the public, the HCA must represent the PPMW commitment to quality healthcare and excellent customer service. Responsible for the performance of front desk, telephone and health care center duties and adherence to PPMWs policies, procedures and medical standards and guidelines, using a customer centered approach to health care delivery.

Core Functions:

• Display initiative in maintaining an attractive and impeccably clean clinic environment, including public restrooms, waiting areas, lab, exam rooms, and reception area.
• Ensure the good working condition of office and lab equipment identifying and reporting malfunctions promptly.
• Participate in PPMWs inventory program to ensure adequate and accurate inventory.
• Participate in all clinic efforts to achieve benchmarks set for excellence of care and productivity.
• Demonstrate consistent excellent customer service.
• Greet clients and visitors in a positive, warm, caring, friendly manner.
• Safeguard the privacy and protected health information of clients in compliance with law and PPMW policies.
• Ensure that Request for Medical Services and Acknowledgement of Receipt of HIPAA Privacy Information has been signed by the client prior to the provision of care.
• Participate in PPMWs Risk and Quality Management (RQM) and Referral Follow-Up programs.

Front Desk/Reception (Function 1)

• Manage flow of clients and visitors in the reception area. Process over the counter sales of medications.
• Process incoming and outgoing faxes.
• Record incoming payments according to PPMW policy and procedure guidelines.
• Maintain adequate inventory of supplies, forms and other items as necessary.
• Collect and input client registration information.
• Provide patients with forms and fact sheets essential to the level of services requested.
• Complete day-end procedures such as preparing deposit and balancing cash drawer according to PPMW policy.
• Maintain strict cash control.
• Assess client finances, which may include verifying insurance, health plan authorization, determining grant eligibility, or determining sliding-fee scale status.
• Ensure that patient visits are initiated, entered and closed in a timely manner.
• Collect fees per PPMW guidelines, and complete appropriate documentation.
• Provide general information and patient education.
• Document phone conversations in patient records as indicated. Facilitate appointment scheduling.
• Triage and refer calls appropriately.
• Assign electronic tasks for RN/clinician calls.
• Disburse contraceptive supplies with correct authorization and documentation.
• Ensure adequate inventory of supplies at dispensing station.
• Ensure that prescription labels are present and product inserts are given as indicated.
• Respond efficiently to requests to telephone/mail/electronic requests for refills.

Family Planning Clinical Assistant (Function 2)

• Collect vital signs (blood pressure, pulse, temperature, height, weight) as indicated for client visits.
• Interview client to attain appropriate information about health history, primary purpose of visit, and needs assessment.
• Work in conjunction with the clinician, RN, or physician.
• Complete chart and billing documentation accurately to include all labs performed, supplies given and patient care.
• Ensure and document that appropriate education/fact sheets are provided for any education provided by the HCA.
• Ensure that informed consent including review of risk, benefits, and alternatives is obtained and all appropriate forms are completed and signed prior to the provision of any special services/procedures.
• Set up, maintain, and clean exam rooms for all procedures (leep, colpo, larc, etc)
• Maintain adequate inventory of all supplies, promptly alert Center Manager of any supply requests.
• Audit exam rooms to ensure supplies are stored correctly and used or discarded prior to expiration.
• Perform venipuncture and finger stick blood collection.
• Perform basic on-site lab tests such as pregnancy testing, urinalysis, hemoglobin, and Rh typing.
• Perform rapid-result HIV testing and short-term counseling in compliance with local regulations and CDC procedures.
• Collect and appropriately prepare and package specimens for transport to off- site laboratories.
• Collect vital signs (blood pressure, pulse, temperature, height, weight) as indicated for client visits.
• Maintain lab according to OSHA and CLIA standards and guidelines.
• Perform routine autoclave maintenance including draining, cleaning, and spore testing.
• Ensure accuracy of lab logs, including findings and follow-up per protocol.
• Perform and record all laboratory controls.
• Participate in laboratory proficiency testing program and annual lab skills competency evaluation.
• Disburse contraceptive supplies with correct authorization and documentation.
• Ensure adequate inventory of supplies at dispensing station.
• Ensure that prescription labels are present and product inserts are given as indicated.
• Respond efficiently to requests to telephone/mail/electronic requests for refills.
• Provide appropriate referrals and information (prenatal care, adoption) to clients who do not desire abortion.
• Discuss clients social support and offer additional supports (talk lines, websites, community resources) as indicated.
• Conduct intimate partner violence (IPV) and reproductive coercion screenings; address positive screenings or refer to RN/clinician/physician.
• Advise client of all abortion methods appropriate for gestational age.
• Educate client about desired abortion method, including review of risks and benefits.
• Ensure that informed consent is obtained, and all appropriate forms are completed and signed.
• Give and document the appropriate fact sheets for any education provided by the HCA.
• Offer information about contraception and safer sex to all clients.

Primary Care Clinical Assistant (Function 3)

• Physical Exams
• Incision & drainage
• Cryotherapy
• EKG
• Rapid Flu Test/Rapid Strep Test
• Fecal Occult Blood Test
• Vaccines/Vaccine Administration
• Maintain adequate inventory of all supplies; promptly alert Center Manager of any supply requests.
• Perform basic on-site lab tests such as urinalysis, hemoglobin, and glucose
• Collect and appropriately prepare and package specimens for transport to off- site laboratories.
• Collect vital signs (blood pressure, pulse, temperature, height, weight) as indicated for client visits.
• Maintain lab according to OSHA and CLIA standards and guidelines.
• Ensure accuracy of lab logs, including findings and follow-up per protocol.
• Perform and record all laboratory controls.
• Participate in laboratory proficiency testing program and annual lab skills competency evaluation
• Provide appropriate referrals
• Conduct intimate partner violence (IPV) and reproductive coercion screenings; address positive screenings or refer to RN/clinician/physician.
• Ensure that informed consent is obtained and all appropriate forms are completed and signed.
• Give and document the appropriate fact sheets for any education provided by the HCA.

Surgery Assistant (Function 4)

• Prepares rooms before and cleans rooms after procedures, ensuring all materials needed by the clinician are present and ready for use.
• Assists the client and clinician as needed during the procedure.
• Supports the client in their immediate post-procedure recovery, including transfer to a monitored recovery area when indicated.
• Recognizes typical/atypical intra- and post-procedure client status and requests assistance appropriately.
• Assess clients pregnancy decision.
• Provide appropriate referrals and information (prenatal care, adoption) to clients who do not desire abortion.
• Discuss clients social support and offer additional supports (talk lines, websites, community resources) as indicated
• Conduct intimate partner violence (IPV) and reproductive coercion screenings; address positive screenings or refer to RN/clinician/physician.
• Advise client of all abortion methods appropriate for gestational age.
• Educate client about desired abortion method, including review of risks and benefits.
• Ensure that informed consent is obtained and all appropriate forms are completed and signed.
• Give and document the appropriate fact sheets for any education provided by the HCA.
• Offer information about contraception and safer sex to all clients.
• Perform and record all laboratory controls
• Perform basic on-site lab tests such as pregnancy testing, hemoglobin, and Rh typing.
• Perform venipuncture and finger stick blood collection.
• Collect vital signs (blood pressure, pulse, temperature, height, weight) as indicated for client visits.
• Interview client to attain appropriate information about health history, primary purpose of visit, and needs assessment.

Qualifications:

• High school diploma, GED or equivalent certification required.
• Certification as medical assistant preferred.
• Minimum 2 years of customer service or related experience preferred.
• Family planning experience preferred.
• Demonstrated ability to perform work accurately and with attention to detail.

Compensation details: 24-28 Hourly Wage

PIe017ed38e1

• Develop, implement, and manage a comprehensive QC/QA program for facility operations and maintenance.
• Provide a detailed method statement explaining the setup, management, and execution of QC/QA processes.
• Oversee quality assurance activities across large-scale building systems, including mechanical, electrical, HVAC, and related infrastructure.
• Apply RCM principles to improve system reliability, reduce maintenance costs, and support long-term asset performance.
• Utilize non-destructive testing (NDT) techniques to evaluate equipment performance and identify potential failures.
• Supervise QC/QA staff and ensure compliance with Amentum, Department of State (DOS), and federal quality standards.
• Conduct inspections, audits, and evaluations of O&M activities and projects.
• Provide technical guidance, corrective action recommendations, and continuous improvement strategies.
• Prepare documentation, reports, and quality performance metrics to support contract compliance.
• Collaborate with project managers, engineers, contractors, and stakeholders to drive quality excellence.

• Minimum 15 years of experience working on major industrial complexes or construction projects in a QC/QA role.
• Minimum 5 years of experience as a QC/QA Supervisor.
• Strong working knowledge of O&M operations and building system infrastructure.
• Experience in RCM programs and non-destructive testing methods.
• Ability to develop and deliver a comprehensive QC/QA method statement.
• Secret Clearance required.
• Strong documentation, organizational, and communication skills.

• Certification such as CQI (Certified Quality Inspector) or related quality credentials.
• Experience in DOS, federal, or mission-critical facility environments.
• Background in engineering, facility operations, industrial maintenance, or similar technical fields.
• Experience building or managing QC/QA teams in complex environments.

• Health, dental, and vision insurance
• Paid time off and holidays
• Retirement benefits (including 401(k) matching)
• Educational reimbursement
• Parental leave
• Employee stock purchase plan
• Tax-saving options
• Disability and life insurance
• Pet insurance

• 
  
• Act as the Technical Authority - Specify Manufacturing Engineering and process requirements and make technical decisions in relation to the area of accountability and chair the Control Authority(s) governing change for area of accountability, subject to appropriate delegation.
  
• Own foundry process capability standards, qualification strategies, and revalidation plans.
  
• Quality - Promote a culture of zero defects within the area of accountability and ensure that manufacturing processes and methods of manufacture within the business and suppliers are developed and deployed to support Right First-Time manufacture; coaching the community in the use of RRPS, RCCA and Systems Engineering tools
  
• Ensure robust, capable investment casting processes including wax pattern production, grain control, solidification, and defect mitigation.
  
• Lead technical strategy for single crystal yield improvement, defect reduction and process robustness.
  
• Partner with Materials, Quality, and Design Engineering to align casting process capability with design intent and material requirements.
  
• Improvements - Identify, evaluate, and govern the requirements for improvements and innovations in manufacturing processes and methods of manufacture within their area of accountability.
  
• Deploy capability - Maintain and/or govern Production Technical Packages (technical instructions, programs, tooling, etc.) for all parts/assemblies which clearly define the manufacturing process whilst ensuring manufacturing processes and/or methods of manufacture within the business and suppliers are capable of meeting and continuing to meet requirements for quality, cost, delivery rate and lead-time.
  
• Product Safety - Responsible for ensuring that product safety risks are understood and mitigated to meet the required safety levels and reduce the safety risks so far as is reasonably practicable and champion product safety and promote a product safety culture in the supply chain, ensuring learning related to product safety is embedded.
  
• Drive measurable improvements in foundry performance including yield, scrap, CoNQ, throughput, takt adherence, and lead time.
  
• Identify, evaluate, and govern investments in process improvements, automation, digital tools, and technology insertion.
  
• Translate technical improvements into sustained operational results through standardization and control.
  
• Lead, coach, and develop a team of Manufacturing Engineers, building depth in investment casting and single crystal expertise.
  
• Set clear expectations linking technical rigor to operational outcomes.
  
• Act as a mentor and role model for disciplined problem solving, accountability, and continuous improvement.
  

• 
  
• Bachelor's degree with 5+ years of experience in Manufacturing Engineering, OR;
  
• Master's degree with 3+ years of experience in Manufacturing Engineering, OR;
  
• JD/PhD, OR;
  
• In lieu of a degree 9+ years of experience in Manufacturing Engineering
  
• Must be a U.S. Citizen or Permanent Resident to be considered for this role
  

• 
  
• Demonstrated leadership experience in investment casting and/or single crystal foundry operations
  
• Proven track record of driving measurable operations performance improvements in yield, scrap, cost, or delivery
  
• Experience serving as a technical authority or leading process governance for complex casting operations
  
• Demonstrated use of data-driven problem solving methods such as Six Sigma, RCCA, and statistical process control
  
• Experience with manufacturing change including technology insertion, new product introduction, process requalification, or capacity expansion
  
• Knowledge of aerospace materials, tolerances, GD&T, and Design for Manufacture principles
  
• Strong mentorship, interpersonal, and communication skills with experience developing engineers
  

About the Role

The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

Responsibilities

• Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
• Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
• Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
• Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
• Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
• Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
• Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
• 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
• 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
• Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
• Proven experience tracking testing deliverables, coordinating QC schedules

Preferred Skills

• Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
• Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.

Role Title - Quality Control Analyst III, Analytical

Department- QC

Reports to- QC Manager, Analytical

FLSA -Exempt

Salary Range: $80k- $90k

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

COMPANY DESCRIPTION

Polaris Pharmaceuticals, Inc., an affiliate of the Polaris Group ( ), is a therapeutic protein drug manufacturer located in Vacaville, California. Polaris has a cGMP facility producing biological study drugs to support all Polaris Group clinical trials at various stages in the USA, Europe, and the Asian-Pacific region.The lead project of the company is now in clinical trials for patients with different types of cancer including mesothelioma, sarcoma, and glioblastoma. Polaris is seeking candidates to help with the production of this protein drug as well as the production of products for our clients and partners.

ROLE SUMMARY

The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples compliant with cGMP guidelines. The Analyst works independently on assays that he/she has mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

ROLE RESPONSIBILITIES

• Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Reviews test data for accuracy, data integrity, system suitability, and conformance against defined criteria/specifications.
• Provides technical support with troubleshooting of test methods, as needed.
• Identify and contribute to OOS/OOE/OOT investigations related to testing performed.
• Initiate and author deviation and laboratory investigations.
• Maintains the laboratory in an inspection-ready state.
• Develops and maintains proficiency in a broad range of trained test methods.
• Train analysts on test methods and procedures.
• Responsible for authoring Change Control records and leading the revision of written procedures as assigned.
• Holds self and others responsible to abide by department and company policies and practices.
• Adheres to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements.
• Manage reagent and equipment inventory for assigned areas of responsibilities.
• Responsible for sampling and testing of incoming raw materials

SKILLS

• Strong working knowledge of cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Works independently as well as in a team environment.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Strong documentation skills a must. The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation. Experience with Protein analytics, SDS-PAGE, separations technology for HPLC, Chromatography Data Systems (CDS) software such as OpenLab, subvisible particles testing (USP ), and CCIT preferred. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

QUALIFICATIONS

B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). Minimum of 5 years of relevant laboratory experience is desired.

Build Your Career with Ashley Furniture

Manufacturing Supply Chain Manager

Location is Onsite: Ecru, MS or Advance, NC

What Will You Do?

The Manufacturing Supply Chain Manager will manage the generation and execution of manufacturing plans from the development of the Master Schedule through packing of the units in Assembly. Collaborate with Manufacturing, Purchasing, and IT to drive improvements to materials and inventory management programs. Lead the search and implement breakthrough strategies that improve utilization by increasing throughput, inventory turns and reduction of cycle time. Continuously improve systems, methods, procedures, people and computer systems.

What Do You Need?

• 6 years’ experience in Manufacturing Supply Chain Management, Required
• APICS CPIM certification, or ability to obtain within 3 years, Required
• APICS CSCP certification preferred or equivalent education or experience
• APICS CPIM, Required and APICS CSCP or equivalent and Abilities
• Progressive production and inventory control methods and techniques
• Advance planning and scheduling (APS) systems and methodology
• Fundamental product engineering methods
• Bills of materials – Item Types and Routings and Standards
• Working knowledge of Continuous Improvement
• Proficient computer skills, including experience with Microsoft Office Suite, internet
• Bachelor Degree in Manufacturing Supply Chain Management or related field or equivalent work experience

What Will You Do

• Develop, implement and maintain a manufacturing plan for multi-plant operations using a Supply Chain Management scheduling system. Review and make recommendations for approving the Master Schedule for sequence of models in assembly by reviewing machining, labor and material constraints.
• Maintain strong attention to material utilization, process flow, cycle time and inventory management.
• Monitor, revise and control execution of the plan on the shop floor using a Supply Chain Management scheduling system. Prioritize the sequences of manufacturing work orders; adjust queue times, move times and lead times to improve throughput.
• Assist in the development of the shop floor production strategy. Review the throughput capacity requirements planning (CRP) report weekly with manufacturing management looking for short-term problems at selected work centers. Review the throughput Load-to-Capacity reports monthly with appropriate management looking for potential long-term constraints associated with manufacturing and assembly work centers. Suggest the use of overtime as required.
• Meet quarterly with sales and operations management to review sales forecast numbers of existing products and new forecast numbers from new product introductions. Using the APS, create a Load to Capacity chart to determine and evaluate the impact of machinery, materials, methods, environment and people for all manufacturing divisions: casegoods, upholstery and bedding.
• Work closely with P &IC Managers in other facilities to make recommendations and implement necessary changes to manufacturing systems to improve flow of materials to achieve standardization of planning systems throughout the organization.
• Evaluate the effectiveness of the manufacturing plan and the results of its execution with the goal of meeting or exceeding scheduled completion goals for each facility. Work with P &IC Managers and planners to make recommended changes to Advanced Scheduling Systems (through-put) model.
• Assist with directing the activities of the Manufacturing Supply chain planner; collaborate with P &IC supervision, planners and clerical personnel to resolve planning issues and provide training and education in Material Requirements Planning (MRP), MAPICS XA, APICS, CPIM and CSCP.
• Provide continuous improvement of the manufacturing operations computer systems and departmental processes. Collaborate with the IT organization to improve current and new programs. Develop and annual budget for equipment and personnel.
• Work closely with all other functional areas of the company to achieve profit and growth objectives.
• Demonstrate the Company’s Core and Growth Values in the performance of all job functions.

Who We Are

At Ashley, we’re more than a business…we’re family. As the largest manufacturer of home furnishings in the world, we know what it takes to build incredible furniture and future leaders. We’re problem solvers with the grit to persevere during challenging times and innovators who won't coast when times are good. We create solutions, not excuses. And never settle for status quo. It’s the reason we’re always searching for better ways to delivering an exceptional customer experience. That's why Ashley Furniture is #1 in our industry.

Ready to grow? You’ve come to the right place. Ashley Furniture has a “Growth Mindset”, and once you join our team, you’ll learn from the best in the business.

Apply today and find your home at Ashley!

Benefits We Offer

• Health, Dental, Vision, Employee Assistance Program
• Paid Vacation, Holidays, and Your Birthday off
• Generous Employee Discount on home furnishings
• Professional Development Opportunities
• Ashley Wellness Centers (location specific) and Medical Tourism
• Telehealth
• 401(k) and Profit Sharing
• Life Insurance

Our Core Values

• Honesty & Integrity
• Passion, Drive, Discipline
• Continuous Improvement/Operational Excellence
• Dirty Fingernail
• Growth Focused

To learn more about Ashley Furniture, our community engagement programs, environmental stewardship, and our core values, please visit our Corporate Social Responsibility information page:

Corporate Social Responsibility

We are an equal opportunity employer and provide a drug-free working environment. While Ashley appreciates the interest of all candidates only those meeting specific position requirements may be contacted. Principals Only.

Plans and coordinates the pre-press department workflow in a manner which will consistently meet customer requirements and meet team and corporate profit goals. Provides leadership to all screen and digital pre-press production art personnel. Participates with Sales department on new design requests. Continually effects improvement in quality, methods and productivity by identifying waste and eliminating it. Provides technical knowledge and assistance to all areas.

DUTIES

Oversees daily screen and digital pre-press production art activities including file preparation, color management and proofing to ensure efficiency and quality standards are met.

• Schedules and monitors the daily pre-press production art workflow to ensure timely and efficient production.
• Controls and monitors processes; ensures in-process inspections are conducted.
• Works with sales, customer service and production teams to pre-plan orders, determine optimum processing methods, resolve artwork issues and clarify specifications.
• Oversees color management programs for screen and digital printing processes.
• Communicates with internal staff and customers as needed to provide technical assistance.
• Ensures a system for maintaining art files and archives.

Meets with and collaborates with Sales on new design requests.

• Determines scope of project.
• Recommends proper materials for project.
• Reviews nesting and various size elements.
• Assists Estimating with pricing.
• Provides technical guidance on structural elements of point-of-purchase (POP) displays.
• Collaborates with outside creative design personnel.

Management responsibilities.

• Conducts area meetings on a regular basis.
• Evaluates direct staff via the performance review process.
• Equitably interprets and enforces company policy within the area.
• Identifies, recommends and coordinates with manager and Human Resources, all decisions regarding hiring, training, evaluating, promoting and disciplining of associates consistent with corporate policies.
• Ensures training and cross training of staff.
• Keeps manager informed of problems adversely affecting the team; makes recommendations for corrective action.
• Ensures all safety practices and procedures are followed; provides appropriate training and equipment.

Responsible for quality improvement process.

• Develops process operator instructions and work instructions and conducts periodic audits of same.
• Ensures compliance with quality procedures including Blaze and First Article Inspections.
• Ensures timely response to formal and informal corrective action through the immediate use of problem solving tools to prevent reoccurrence.

Performs other duties as assigned or apparent.

KNOWLEDGE, SKILLS AND ABILITIES

• Thorough knowledge of screen and digital printing processes.
• Thorough knowledge of print and color theory, and appropriate methods to produce required art and digital files.
• Thorough knowledge of various pre-press software and technologies such as Mac software, and Adobe Creative Suite.
• Thorough knowledge of pre-press operations and printing processes, including file preparation, color correction, and proofing techniques.
• Considerable knowledge of structural point-of-purchase (POP) design elements.
• Working knowledge of electronic cutting equipment, methods and processes (i.e. Zund, Kongsberg, Routers, Plotters.)
• Considerable ability to identify, analyze and resolve production-related problems including troubleshooting file issues and quickly resolving technical challenges.
• Considerable ability to lead departmental staff, provide performance feedback and technical guidance.
• Considerable ability to deal tactfully and effectively with associates, vendors and customers, while supporting company policies.
• Considerable verbal and written communication skills.
• Considerable ability to work in a high-pressure, demanding work environment.
• Considerable ability to stay abreast of technological advances and trends in the printing industry.

MINIMUM QUALIFICATIONS

• Bachelor’s degree from four-year college or university with emphasis on commercial art, or computer graphic design.
• Five years of screen printing and/or digital imaging pre-press experience.
• Two years of Pre-Press management experience.
• Must not be color blind.

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

MAU is hiring an Advanced Manufacturing Engineer for our client in Gainesville, GA. As an Advanced Manufacturing Engineer, you will design, develop, and enhance manufacturing processes that meet product requirements while prioritizing operator safety. This is a direct-hire opportunity.

Benefits Package

• 401(k)
• Health insurance
• Dental insurance
• Vision insurance
• Paid vacation
• Paid holidays
• Paid time off
• On-the-job training
• Opportunity for advancement

Shift Information

• Monday – Friday | 7:30 AM – 4:30 PM

Required Education and Experience

• Bachelor’s degree in Engineering or a related field, with a focus on manufacturing.

Preferred Education and Experience

• Experience with AutoCAD.
• Background in engineering within a manufacturing environment.
• A Master’s degree in a manufacturing-related engineering field

General Requirements

• Demonstrated ability to work with complex manufacturing systems.
• Strong skills in problem-solving, leadership, and communication.
• Experience with manufacturing methods, quality assurance, and presenting technical information to diverse audiences.
• Proficiency with CAD tools; familiarity with CAD/CAM and design documentation.
• Demonstrated interest in innovation, Industry 4.0 manufacturing technologies, and continuous improvement (e.g., automation, simulation, digital tools, data-driven process optimization).
• Naturally curious and comfortable exploring new tools, methods, and technologies to enhance safety, quality, and productivity.
• Experience leading a project or coordinating cross-functional teams in academic, co-op, or professional settings.
• Ability to drive initiatives from concept through implementation while maintaining alignment with stakeholders on the shop floor and in the office.

Essential Functions

• Design manufacturing processes that meet product requirements and prioritize operator safety
• Collaborate with equipment vendors and conduct research to develop safe and efficient production methods
• Develop manufacturing processes with poka-yoke solutions to prevent quality issues
• Design testing methods and evaluate finished products to ensure high-quality standards
• Analyze workflows, space needs, and equipment layouts using Kubota’s 5-Gen and KPS Principles
• Support production decisions by calculating costs, reviewing schedules, and estimating future needs
• Lead project activities, managing timelines, budgets, and vendor coordination
• Collect and analyze data to prepare process and product reports
• Create and maintain standard operating procedures and technical documentation
• Support continuous improvement and Kaizen initiatives to meet safety, quality, and productivity goals
• Research and recommend the adoption of technologies such as AI, automation, simulations, and vision systems
• Ensure compliance with relevant government regulations
• Collaborate with maintenance teams to develop preventative maintenance plans for new equipment
• Adhere to company policies and propose improvements to existing standards
• Design tooling and fixtures using CAD applications, and maintain design records
• Train technicians and operators on new or updated processes
• Stay current through workshops, publications, and professional organizations
• Support team members during high-capacity periods and share best practices

Working Conditions

• Work in a dynamic, loud production environment with varying temperatures
• Regularly work on the shop floor in collaboration with technicians, operators, and maintenance staff

Physical Demands

• Stand for extended periods and walk the shop floor regularly
• Sit for design, analysis, and documentation tasks
• Operate power and handheld tools as needed for manufacturing support

MAU Workforce Solutions is an innovative global company with extensive experience providing solutions for success in staffing, recruiting, technology and outsourcing to our clients, employees, and applicants. Headquartered in Augusta, GA since 1973, MAU is a family and minority-owned company offering better processes and better people to create efficiencies and greater profits for our clients. Our relationships with world-class companies, our training programs and our culture of family allow MAU to offer better results, better jobs, and better lives to those who work with us.

All Applicants must submit to background check and drug screening

Disclaimer: This job description is not designed to be a complete list of all duties and responsibilities required of the position

EOE

Location: 100% on- site in Delano, MN at a medical manufacturign facility

About the Company

Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical device and biopharmaceutical companies.

About the Role

We are seeking a Senior Manufacturing Engineer to join the Delano team. Follows good manufacturing practices (GMP) and principles to provide engineering support and develop robust manufacturing processes. Has a primary role in the engineering of new, modified and/or existing manufacturing operations in a clean-room environment. Apply engineering theory and principles to ensure that the Value Stream for specific products is optimized using Lean Sigma tools.

Responsibilities

• Analyze product specifications and translate these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
• Identifies tooling related issues and communicates/works with a tool maker to resolve the issues.
• Develop manufacturing methods for new and existing products, establish labor standards and develop product cost information.
• Meticulously document all manufacturing process information and sequences within the Trelleborg document control system.
• Identify opportunities for improvement to existing processes and methods using data or observation. Develop the improvements and implement them as quickly as practical.
• Make improvements to production rates and reduce scrap by identifying and implementing new and better equipment, processes or human factors methods.
• Assist production in troubleshooting production problems with individual components, individual processes and help improve the situation to assure customer delivery dates and superior quality.
• Review production schedules and engineering specifications to resolve production problems.
• CAPA- Active member of the CAPA team responsible for implementing permanent corrective actions.
• DMR- Participate in determination of product DMR disposition plan and approval with the VS team.
• Follow ISO 13485 and 21 CFR part 11 and part 820 and Trelleborg Quality System protocols.
• Execution of DOE's, problem solving, FMEA's, validations, control plans, continuation engineering for products.
• Actively Support Production, Engineering and Quality departments.
• Senior Manufacturing Engineer: including all the above.
• Mentors Manufacturing Engineers and Technicians through experiences and education as opportunities arise.
• Develops ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement.
• Successfully manages multiple high-profile projects simultaneously.

Qualifications

• Bachelor’s Degree in Industrial, Manufacturing or Mechanical Engineering or related discipline or equivalent combination of education and experience.
• Lean Sigma Green or Black Belt certification.
• Polymer Science, Lean Kaizen or other specialized background.
• 7 years of experience in manufacturing engineering or related discipline.
• Demonstrated leadership skills.
• Medical device manufacturing experience.

Required Skills

• Ability to read, write, speak and understand the English language.
• Ability to communicate clearly by conveying and receiving ideas, information, and direction effectively.
• Ability to demonstrate adequate job knowledge to deliver a world-class performance.
• Ability to challenge oneself to consistently meet all goals and deadlines.
• Willingness to strive for excellence by producing work that is free of errors and mistakes.
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately.
• Commitment to making improvements company-wide.
• Demonstrated competence using Microsoft Office.
• Use of statistical analysis software.
• Interpersonal skills and good communication technique.
• Ability to coordinate multiple projects and deadlines, manage and identify the scope.
• Act as a project leader on major projects.
• Lean Manufacturing- Proficient in the use of problem-solving tools such as 5 why, Fishbone, 8D, etc.
• Understanding of manufacturing processes for medical components and devices.
• Good understanding of metrology principles and methods.

Salary Range: $95,000 - $123,000 based on experience.

Equal Opportunity Statement

Trelleborg Medical Solutions is committed to diversity and inclusivity in the workplace.