Archive Jobs in Usa

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• Set-up and operate micro CNC shop equipment such as lathes, mills, and saws.
  
• Being able to follow all safety procedures in working and machining in a laboratory that works with beryllium components.
  
• NC programming in both manual (i.e., plain G-code and parametric G-code) and CAD/CAM (Creo).
  
• Inspect parts using mics, calipers, digital height gages, measuring microscope, indicators, gage blocks, surface plates, etc. as required.
  
• Inspect parts using high level inspection tools such as CT and white light optical profilers.
  
• Record and document machining data, including both in-process and final inspection results, in the database or designated Excel templates, and archive them on the server.
  
• Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices.
  
• Performs other duties as assigned or required.
  

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• Typically requires a high school diploma, technical/trade school training or equivalent and two or more years related experience.
  
• Must possess:
  
• Proficiency with common manual shop equipment such as lathes, mills, and saws.
  
• Some experience setting-up and operating NC mills and lathes.
  
• Some experience with NC programming (both G-code and CAD/CAM).
  
• Proficiency with common manual inspection tools such as micrometers, calipers, digital height gages, indicators, gage blocks, surface plates.
  
• Knowledge of computer operations and applications pertinent to the field required.
  
• Customer focus.
  
• Ability to use good judgment and safe practices in a shop environment.
  
• Time management skills to maintain the flow of work within the unit.
  
• Good interpersonal skills and written communication skills to interface with employees and supervisor; and basic computer skills.
  
• Ability to work in a large lab research environment requiring long periods of standing, walking, bending and lifting up to 50 lbs.
  
• Ability to work both independently and in a team environment.
  
• Ability to handle parts under 10 mm in size
  
• Flexibility to work extended hours as required.
  
• Must be willing to work with hazardous and radioactive materials
  
• Must have the ability to obtain and maintain a DoE Q Level Security clearance.
  

CGI Federal is looking for outgoing, experienced Bilingual (English/Spanish) Support Associates to join our team. The ideal candidates should possess excellent communication skills (translation and Spanish speaking requirements as needed), have experience in customer service, and be able to work as a team in a fast-paced environment. This position processes highly-sensitive and confidential information. Experience with contracts and processing is preferred.

The Support Associate Level III provides support to the Government staff and performs accounting functions, prepares letters, reports and specialized correspondence. Anticipated tasks include, but are not limited to, the following:

• Assist with any Spanish speaking needs and or required translation of correspondence and/or documents
• Prepare and mail envelopes with correct passport and corresponding supporting documents.
• Box and archive files for storage purposes
• Interface with Passport applicants at Agency/Center information and will-call counters:
  • At the Information Station, ensure appointment is scheduled;
  • Review Passport application, photograph, identification and supporting documentation for completeness prior to adjudication;
  • Ensure the application and documents complies with passport requirements, photograph meets passport standards, and customer is provided fee information.
• Operate equipment for scanning, image review, book print, quality control, and metering mail.
• When operating a four-printer pod, prints passports at a rate of 50 to 65 passports per hour and reviews printed books for data accuracy and product quality.
• Process refund/reimbursement requests.
• Generate a credit card payments and distribute completed batches to the cashier's office.
• Participate in customer service outreach activities.
• Assist with acceptance agent training: prepare training materials, conduct \"meet-and- greets,\" set-up training sessions, conduct office tours, etc.
• Assist CSM in maintaining and cataloging electronic records of passport acceptance facilities.
• Distribute newsletters and any other correspondence to staff.
• Contact applicants to request necessary documents.
• Per the guidance of DOS Passport Specialists, generate correspondence to resolve application discrepancies, including: Return to Sender, Rewrites and Re-issues, and re-batch into the system.
• Review Passport application data to ensure information is recorded accurately into DOS systems.
• Handle complaint letters/phone calls.
• As requested by DOS Passport Specialist, perform administrative review on suspended applications.
• Verify all applications to determine the proper payment for expedite service.
• Perform Quality Control in verifying that application data matches Passport processing data.
• Assist in training lower level Support Associates in job functions, duties, and tasks.
• Assist with \"not issued cases\" including photocopy of application and attachments, set up of application to be abandoned, and forwarding hard copies to requesting Agency.
• Communicate with stakeholders, such as: Congressional offices, community-based organizations, USPS, Lockbox, and other Government Agencies under the direction of the CSM.
• Identify and take initiative to report trends or patterns in the volume or nature of inquiries handled.
• When not directly assisting Customer Service, serve as a member of NPIC search team.
• Conduct research on Passport cases by gathering information from a variety of sources. Provide recommended findings in a clear and concise manner that summarize the information gathered and identified during research. Perform analyses on passport cases being suspended to identify trends that may be useful in future research. Identify errors and areas for improvement in memos associated with these applications.

Due to the nature of the government contract requirements and/or clearance requirements, US Citizenship is required. The selected candidate must be able to frequently lift and carry up to 45lbs. This position may require long hours of standing. As a result, the selected candidate will be expected to be able to stand and walk around the worksite for the entirety of their shift. Ability to remain flexible and adapt under pressure in stressful situations and follow instructions and established procedures. Capable of performing repetitive tasks while maintaining a high level of accuracy. Bachelor's Degree (OR) 4 years of experience as a Support Associate Level II or III (or) 4 years of experience data entering in a high volume production environment. Four years of general office experience, including three years of experience with Microsoft Office. ALL CANDIDATES must pass a pre-employment language assessment measuring their proficiency in speaking, reading, and writing, in Spanish. Candidates must score at an Advanced Level on the pre-employment assessment administered by ALTA Language Services to remain eligible for consideration for the position. Due to the nature of the government contract requirements and/or clearance requirements, US citizenship and ability to obtain a Government Level clearance is required.

• Customer Service & Support
• Data Entry
• Detail-oriented

Together, as owners, let's turn meaningful insights into action. Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you'll reach your full potential because You are invited to be an owner from day 1 as we work together to bring our Dream to life. That's why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company's strategy and direction. Your work creates value. You'll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise. You'll shape your career by joining a company built to grow and last. You'll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons. Come join our teamone of the largest IT and business consulting services firms in the world.

As the need for nuclear energy grows, the future couldn't be brighter. Join our vital mission to create lasting solutions for our planet's greatest challenges. In this role, you are ready to shape the future of clean energy and make a long-lasting global impact. With us, anticipate engaging and challenging projects that deliver innovative solutions and value-added technologies helping power more than 38 million North American homes.

Here's what you'll do:

• Reviews/recommends disposition of procedures and specifications from other departments.
• Reviews fabrication and assembly documentation for compliance.
• Performs documentation reviews to ensure supplier and manufacturing compliance with specifications, drawings, and purchase order.
• Creates (CR) condition report as needed.
• May write/revise quality procedures, SWIs (Standard Work Instructions), and operator aides.
• May train other quality employees.
• Promotes a safe and healthy work environment by following safety rules.
• Documentation/Verification role:
• May prepare quality standards documentation for approval.
• Provides assistance and administrative expertise to internal and external customers in the processing of component dispositions and manufacturing risks within WebCAP.
• Ensures proper archival of quality records.
• May prepare data package files and generate release document for materials, components, and assemblies.
• May prepare product certification packages for submittal to customers.
• Assists CAPs program coordinator.
• Helps internal and external customers in WebCAP functions.
• Surveillance role:
• Conducts oversight and verify product center compliance with procedures, SWI's, and other applicable instructions.
• Conducts physical measurements and tests of components as needed to verify quality characteristics.
• Utilizes judgment and experience to identify issues which affect product quality.
• Conducts independent verification of completion of actions reported as complete within the corrective action program.

Here's what you'll bring:

• Documentation/Verification role:
  • High School diploma or equivalent education with a minimum of 5 years of related experience.
• Surveillance role:
  • High School diploma or equivalent education with a minimum of 5 years of related manufacturing experience in a nuclear fuel facility.
• Knowledge of commonly-used concepts, practices, and procedures within the field.
• Good communication skills to comprehend procedures, specifications, and drawings with ability to work effectively with all levels of staff and management, vendors, and customers.
• Ability to evaluate documentation for compliance.

Total Rewards Package

• Salary: $24.10 - $31.50, and may also include annual incentives and performance bonuses. The base salary range is a guideline. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
• Health & Wellness: Multiple medical plan options, dental & vision coverage, life insurance, long- and short-term disability, and optional supplemental plans (critical illness, accident, hospital indemnity, dependent life).
• Retirement: 401(k) with employer match.
• Paid Time Off: Up to 3 weeks of vacation, 8 sick days, and 13 paid holidays annually.
• Extra Perks: Lifestyle spending account, employer paid mental health support, education reimbursement, professional development opportunities, adoption assistance, parental leave, and employee assistance programs.

Framatome has been shaping the future of nuclear energy in the U.S. for more than 60 years. Framatome Inc. is headquartered in Lynchburg, Virginia, with more than 2,400+ employees across North America supporting nearly every nuclear plant in the nation.

From our facilities in Virginia, Washington, North Carolina, Pennsylvania, Massachusetts, and beyond, we deliver outage services, advanced nuclear fuel technologies, and next-gen reactor innovations that keep the lights on.

At Framatome, you will join a global team committed to creating reliable, carbon-free energy. Here, you can:

• Solve complex nuclear challenges that directly impact the climate.
• Build your career through technical fellowships, leadership roles, and global opportunities.
• Do your best work in a culture that values safety, innovation, and well-being.

Framatome is an Equal Opportunity / Affirmative Action Employer. All qualified applicants receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Offers are contingent on background check and drug screen (where applicable). Positions may involve access to information subject to U.S. export control regulations; applicants must meet eligibility requirements (see DOE 810 Appendix A).

We are currently seeking an experienced Board-Certified or Board-Eligible Non-Invasive Cardiologist for a full-time, permanent position near Roswell, GA. This role provides an excellent opportunity to join a dynamic and established cardiology practice that is known for its quality care and dedication to patient outcomes.

Position Highlights:

• Inpatient Support: Dedicated inpatient Advanced Practice Provider (APP) assistance available daily to optimize your workflow.
• Team Collaboration: Join a collaborative group of 3 Interventional and 6 Non-Invasive Cardiologists committed to excellence in cardiac care.
• State-of-the-Art Cardiac Services: The facility provides a comprehensive range of cardiac services, including:
  • ECHO and Nuclear Medicine
  • Transesophageal Echocardiogram (TEE) and PAD Net
  • CPACS (Cardiology Picture Archiving and Communication System)
  • Cardiac Interventions and Catheterizations
  • Permanent Pacemaker Procedures, Cardiac PET Scans, and Cardiac MRI

Requirements:

• Certification: Must be Board-Certified or Board-Eligible in Cardiology.
• Licensure: Georgia medical license or eligibility for licensure in the state.

Location Advantage:

• Situated near the Roswell, GA area, this position offers proximity to a vibrant community with access to excellent schools, cultural attractions, and outdoor recreational activities.

If you're a skilled cardiologist looking to make a meaningful impact within a supportive and highly skilled team, we encourage you to apply. This is a fantastic opportunity to advance your career in a thriving, patient-centered environment.

Apply now using reference Job ID

Pay: $70,000.00 - $80,000.00 per year

Why This Is a Great Opportunity

• Join a respected boutique plaintiff firm where your work will directly support high stakes litigation and meaningful client outcomes
• Step into a senior level role with real ownership over cases from intake through trial and beyond
• Work closely with experienced trial attorneys on catastrophic injury, products liability, trucking, and bad faith matters
• Be part of a modern, fully paperless litigation environment with strong systems and up to date technology
• Competitive compensation, benefits, and a collaborative team culture where your contributions will be valued

Location: Houston, TX (in office)

Note: Must have 5+ years of plaintiff personal injury litigation paralegal experience and strong hands on experience with Texas state and federal court filings, discovery, and trial preparation.

About Us

We are a boutique plaintiff personal injury firm committed to making a positive impact for people going through some of the hardest moments of their lives. Our team values trust, compassion, high standards, and strong advocacy, and we take pride in building a workplace where people are respected and supported. Confidential Employer.

Job Description

• Support attorneys on plaintiff personal injury matters from intake through trial, appeal, and file closure
• Review new files, gather and organize records, and maintain accurate digital case files in the case management system
• Calendar statutes of limitations, court deadlines, scheduling orders, and key case milestones
• Draft pleadings, procedural motions, trial setting materials, and other litigation documents under attorney supervision
• Prepare and manage written discovery, including interrogatories, requests for production, and requests for admission
• Work directly with clients to gather information and help prepare discovery responses
• Organize document productions, Bates stamp records, and assist with e discovery projects
• Coordinate depositions, including notices, subpoenas, scheduling, exhibits, court reporters, and logistics
• Assist with witness coordination, investigation support, and background research
• Help identify, retain, and coordinate expert witnesses and manage expert communications and case materials
• Prepare exhibits, trial notebooks, and trial presentation materials for hearings, mediation, and trial
• Assist with video deposition synchronization and editing for trial presentation
• Support mediation, settlement, post trial, and appeal related tasks
• Coordinate with vendors, process servers, investigators, and outside service providers as needed
• Manage file closing procedures, digital archiving, and organized transition to closed file storage

Qualifications

• 5+ years of plaintiff personal injury litigation paralegal experience
• Strong experience supporting catastrophic injury, products liability, trucking, or similarly complex litigation preferred
• Strong command of litigation terminology, civil procedure, court rules, and filing requirements in Texas state and federal courts
• Proven ability to manage a heavy caseload independently while meeting multiple deadlines
• Strong written and verbal communication skills
• High proficiency with Microsoft Office and PDF management tools
• Experience with legal case management software such as Filevine, Litify, SmartAdvocate, Needles, or similar
• Comfortable working in a fully paperless, technology driven office environment
• Experience with e discovery platforms, trial presentation tools, video depo sync, and courtroom trial support is a plus
• Bachelor’s degree required; paralegal certificate is a plus
• Spanish is a plus but not required

Why You Will Love Working Here

You will be part of a close knit team doing meaningful plaintiff side litigation work that truly matters. This is a hands on role where you will have real responsibility, direct access to attorneys, and the chance to grow in a sophisticated trial practice. The environment is modern, collaborative, and built for people who take pride in doing excellent work.

JPC-770

Job Type: Full-time

Benefits:

• Dental insurance
• Paid time off
• Vision insurance

Quality Assurance Manager

ATTRACTIVE SKILLS / EXPERIENCES:

• Bachelor's Degree in Chemistry, Biology, Engineering or related field (required)
• Experience (3+ years) in a leading/managing a Quality Department/Group
• Demonstrated knowledge of ISO standards (9001; 14001; 15378) along with cGMP
• Experience and knowledge with MS Office applications (especially MS Excel)
• Experience and knowledge with SAP and electronic QMS systems
• Demonstrated communication skills (written / oral) including the ability to read/speak English
• Ability and willingness to work in office and in a production floor setting with moderate noise
• Ability and willingness to work in fast-paced, matrix structured organization
• Willing to work traditional business hours (8am to 5pm) during weekdays (M-F) with the flexibility to accommodate supporting the 24/7 shift schedule

SUMMARY / RESPONSIBILITIES:

• Assist in developing department budget and investment plan(s) according to strategic goals
• Cultivate employee talent through training and coaching measures, while also conducting employee performance reviews
• Support the development and updating of Quality Assurance programs, policies, processes, procedures and controls
• Review, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepancies
• Manage the review of batch records and avoid impacting shipment dates
• Manage Department Training Coordinator activities and projects
• Manage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documents
• Lead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirements
• Measure and analyze Quality System trends
• Oversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)
• Maintain the Archive Room and document retention requirements
• Write and revise Standard Operating Procedures (SOPs) and provide training, as required
• Manage the CAPA and Change-Control process to include, issuing, reviewing and approving steps
• Support all customer or registrar quality related audits and/or evaluations
• Utilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business Unit
• Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findings
• Help promote and implement safety/EHS directives and maintain a clean and safe workspace
• Assure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines

QC Supervisor

Kelly® Science & Clinical is seeking a QC Supervisor for a direct-hire position at a cutting-edge client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location:Ft. Collins, CO (onsite)

Shift: 1st or 2nd

Salary: $100-105,000 + Benefits

Essential Duties & Responsibilities

• Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• Support and execute all potential 3-day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Ensure all samples logged into the LIMS system are submitted correctly.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as required by business demands.

Knowledge, Skills & Abilities

• Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
• Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
• Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in analytical method validation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
• Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
• Knowledge of analytical troubleshooting and product investigation.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
• Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
• Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.

Education & Experience

• Bachelor’s degree in science, preferably in Chemistry or Biochemistry, or Microbiology.
• 6+ years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Supervisory or team lead experience is preferred.

What Happens Next

Once you apply, you’ll move forward to next steps if your background aligns with the role. If not, no worries — you’ll remain in our network, giving our Science & Clinical recruiting team access to your profile, helping open the door to future opportunities.

Duties:

• Primary responsibility is to execute routine Microbiology/Environmental monitoring, Raw Materials testing of bulk drug substance and drug product in a multi-product facility.
• Executes Raw Material sampling, Microbiological compendial testing and sampling of clean rooms (as applicable).
• Proficiency in 1-3 analytical methodologies.
• Performs technical and quality review of data.
• Responsible for routine lab maintenance work and quality and compliance activities.
• Performs duties under supervision and according to standard operating and QC procedures.
• Ensures that all data is organized and archived per appropriate workflows and SOPs.
• Works with GMP and non-GMP databases to ensure all samples are received, logged, stored, distributed and tracked within defined timelines.
• Interacts with Sample Management, QC laboratories and Raw Materials groups to prioritize samples, cross checks SOPs and protocols to ensure all samples have been received and distributed, troubleshoots discrepancies, and relays information back to line management to ensure all samples are tested per appropriate testing schedule.
• Coordinates shipment of samples to contract labs and other testing site.
• Maintain sampling and testing paper records, equipment logs and other controlled documentation.
• Ensure accuracy and completeness of sampling and testing in LIMS system and/or test records.
• Maintain cleanliness and orderliness of the labs.
• Perform QC-related data entry.
• Provides assistance to other group members as needed.
• Responsible for transferring samples from cleanrooms to the labs.
• Familiar with clean room gowning.

Skills:

• 1-3 years of GMP lab and/or clean room experience.
• Gowning and Aseptic techniques.
• Pipetting skills.
• Must be willing to work all shifts including weekend support if needed but primary work hours are during five days a week.

Education:

• Bachelor’s Degree in a Scientific Discipline, preferably in Microbiology

Immediate need for a talented Compliance Specialist II (Manufacturing/Quality). This is a 12 Months contract opportunity with long-term potential and is located in Northborough, MA , USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08294

Pay Range: $33 - $43/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Support department Quality Management System (Change Control, Deviations, CAPA)
• Main Accountabilities- Ensuring that activities within scope are conducted in compliance with applicable regulatory requirements
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Perform finished product inspections according to standards, specifications established timelines
• Perform AQL inspections according to standards, specifications established timelines
• Trend AQL failures according to standards, specifications established timelines
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelines
• Manage / perform annual inspection of retention samples
• Support creation of new material and product specifications
• Perform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
• Support department Quality Management System (Change Control, Deviations, CAPA)
• Support department documentation archival system
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
• Managing / escalating and resolving quality-related issues in a timely and effective manner
• Support the monitoring and analyzing of quality performance metrics, implementing corrective actions as needed
• Support root cause analysis investigations for quality incidents and implementing preventive measures
• Support quality walkthroughs
• Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focus
• Support risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization
• Request corrections when GMP rules are not respected
• Prioritize quality and compliance objectives
• Request quality improvement initiatives and strategies
• Identify discrepancies and corrective/preventive actions that need to be taken
• Escalate to upper management any failure in GMP execution on shopfloor
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures
• Advise on how to present a topic and answer specific questions
• Advise on risk management strategies and plans
• Advise on initiatives to promote a quality-focused culture

Key Requirements and Technology Experience:

• Key skills: - Experience with inspecting finished goods and product
• Quality Shop floor experience
• Fully onsite position Possibility of extension Open to candidates willing to relocate at their own expense
• Top candidates, references will be requested Free parking onsite
• Bachelors degree (Masters and PHD's will be accepted)
• 3 Year experience in related role (more experience the better)
• Quality Shop floor experience, quality assurance review experience
• Experience with inspecting finished goods and product
• Previous pharma and biotech experience / GMP (strongly preferred)
• Change Control, Deviations, CAPA (strongly preferred) • SAP, Veeva
• Minimum 3 years of related experience
• Minimum Education: Bachelors degree

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

COMPANY OVERVIEW

This is a unique opportunity to join a market-leading company in the telehealth industry. We support healthcare providers around the country through our teleradiology services. Using our novel cloud enabled medical image management and interpretation services, we help to advance patient care by facilitating rapid diagnosis from our large network of radiologists and clinical support professionals who all work from their homes.

POSITION OVERVIEW

The Credentialing and Licensing Assistant assists their direct supervisor and/or the Manager, Credentialing and Licensing in all aspects of licensing and credentialing StatRad radiologists, on behalf of StatRad and its clients, which are located across the country. The Credentialing and Licensing Assistant works hand-in-hand with their manager and department colleagues, as well as with the other areas of the company.

PRIMARY RESPONSIBILITIES

• Completing/processing initial and reappointment applications.

• Assisting with physician licensing.

• Ensuring timely renewal of licenses and certificates.

• Keeping track of all credentialing requirements.

• Responding to medical staff office requests.

• Updating physician and medical staff documents.

• Sorting daily credentialing mail/faxes/emails.

• Creating USPS labels and tracking delivery dates.

• Filing and archiving.

• Ability to integrate new responsibilities into current job description when needed.

• General office duties including, but not limited to, answering phones, emailing, faxing, making copies, scanning documents, archiving, opening, and sorting mail, etc.

• Other projects and duties as assigned.

JOB REQUIREMENTS AND SKILLS

• Office equipment (phone, fax, etc.) and computer proficiency necessary, including Microsoft Office (Outlook, Word, Excel, PowerPoint) and Adobe.

• Must be able to learn quickly and work with minimal supervision.

• Ability to effectively prioritize and execute tasks in a high-volume, high-pressure environment.

• Strong customer service orientation and focus.

• Must be reliable and possess extreme attention to detail and documentation.

• Excellent interpersonal and communication skills, both oral and written.

EDUCATION AND EXPERIENCE

• Bachelor’s Degree, preferred.

• Credentialing experience preferred, but not required.

WORK LOCATION AND CONDITIONS

• Corporate office in San Diego. Hybrid Model, 3 days in the office and 2 days remote, with manager approval.

• Job Type: Full-time; Non-Exempt.

REQUIRED TRAININGS

• Internal Regulatory and Quality System training required for Credentialing.

StatRad has implemented a pay scale to reward employees fairly and competitively, as well as to support recognition of employees’ career progress, ranging from entry level to experts in their field, and talent mobility. It reflects the range that StatRad reasonably expects to pay for this position at various levels of experience. The actual pay rate for this position will be dependent on a variety of factors, including an applicant’s relevant experience, unique skills and abilities, education, market demand, and employer business practices, and will be discussed at the offer stage with the selected candidate. The starting hourly pay for full time is $22.00/hour.