Arraylist Methods Jobs in Usa

Provides shop floor support for manufacturing methods and processes in machining, metal finishing and assembly operations for assigned product lines. Maintains Manufacturing Process Planning documentation and insures the accuracy of labor standards. Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.

• Completes activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with the company Corporate CAPA system.
• Completes activities of Lean Sigma projects and process improvements.
• Provides technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.
• Proactively execute and support development of validation/qualifications studies. Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group.
• Responsible for the investigation of change requests received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes.
• Working with the appropriate groups; maintains manufacturing process sheets for all machining, assembly, and finishing operations.
• Makes appropriate changes in manufacturing methods, processes and Manufacturing Process Planning documentation when dictated by engineering drawing changes. Documents all changes through the appropriate change control system.
• Coordinates entry of all master data for assigned product lines. This may include Purchase Requests, Capital Appropriation Request, Inventory Approval Forms, Material Masters, Bills of Material, routings, production versions, work centers, and document information records.
• Coordinates update of production order data as needed
• Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.
• Performs other duties as assigned.

Requirements:

• Working knowledge of industry standards and regulatory requirements (including but not limited to: ISO 13485, ISO 14971, MDD 93/42 EEC, PAL, CMDR, and 21 CFR Part 820). Understands impact of compliance to the requirements and how it relates to their job, or is aware of resources available to them to assist with determining impact.
• Strong communication skills, both oral and written
• Good interpersonal skills
• Ability to work in a fast paced environment
• Ability to work well under pressure and maintain positive, enthusiastic attitude
• Eagerness to learn and expand responsibilities
• Ability to work effectively in a team environment and build strong working relationships.
• Willingness to participate in continuous improvement activities

General Job Description

Responsible for performing and reviewing routine analytical testing of various sample types, including raw materials, intermediates, and drug substance/products to ensure compliance with GMP standards and product specifications. This QC Analyst II position requires team-coordinated work, combined with exercising more independent efforts to troubleshoot methods, support method qualifications, and investigations pertaining to OOS/OOT findings. Increased efforts in document writing and supporting operational aspects of QC team is an important function of this position.

Supervisory Responsibilities

None

Duties and Responsibilities

• Execute and troubleshoot analytical methods including potency assays, qPCR/dPCR, ELISA, and/or flow cytometry.
• Review and interpret analytical data, ensuring accuracy, traceability, and compliance.
• Assist in method qualification, sample management, and stability testing.
• Support OOS/OOT investigations, deviations, and CAPA implementation.
• Train junior analysts and maintain laboratory readiness for audits.
• Contribute to continuous improvement and process efficiency projects.
• Additional duties as assigned.

Education and Experience Requirements

• A Bachelor’s degree in a science related field.
• 2-5 years of industry experience in biologics, vaccines, cell/gene therapy, or a similarly relevant area, utilizing a defined QMS.

Required Skills and/or Qualifications

• Well versed in aseptic technique, molecular biology assays, cell-based potency assay, and/or biochemical/protein assays.
• Familiarity with data integrity principles and electronic systems (LIMS, ELN).
• Should be detail-oriented and have the ability to work independently and productively under general direction, routinely exercise initiative and sound judgment to contribute to team objectives.
• Able to assist in the authorship of complex protocols and reports, and/or quality programs
• Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.

Job Type

• Weekends or weeknight work is occasionally required depending on the production schedule or process needs.

Benefits

• Group Healthcare Plan, including company paid dental and vision.
• Short- and long-term disability, life and AD&G insurance.
• Simple IRA with employer match
• Educational assistance program
• Holiday and PTO

Details:

Job Title: API EM Quality Assurance Professional

Location: Indianapolis, IN

Duration: 12+ Months Contract (extendable)

Pay Range: $70 - $77 per hour on W2.

Qualifications:

At Client, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing organizations (CMs). The QA for QC position is essential for ensuring that all QC testing is in accordance with the validated methods and are compliant to cGMPs and regulatory commitments.

Basic Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

• 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.

• Additional Preferences:

• Testing experience with Small Molecule

• Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories

• Knowledge of pharmaceutical manufacturing operations.

• Demonstrated coaching and mentoring skills.

• Experience in root cause analysis.

• Demonstrated application of statistical skills.

• Demonstrated strong written and verbal communications skills.

• Strong attention to detail.

• Proficiency with computer system applications.

• Excellent interpersonal skills and networking skills.

• Ability to organize and prioritize multiple tasks.

• Ability to influence diverse groups and manage relationships.

Education Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

Other Information:

• Must complete required training for API EM Quality Assurance.

• No certifications required.

• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

• Must be able to support 24 hour/day operations.

• Up to 20% travel US & OUS.

Responsibilities:

Key Objectives/Deliverables:

• Serve as a liaison between CMs and Client.

• Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.

• Provide quality oversight of CM method validation or method transfer activities

• Escalate quality issues at CMs to Client's QA management.

• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.

• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).

• Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.

• Participate in regulatory inspection preparations with CMs.

• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.

• Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.

• Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.

• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.

• Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.

• Participate in APR activities.

• Participate in projects to improve productivity.

• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

As the Principal Packaging Engineer, you will serve as the enterprise-wide technical expert and strategic lead in FDA regulated packaging. The position leverage deep knowledge in packaging including but not limited to design, test methods, standards, and industry insights to create and deliver a pipeline of breakthrough innovations and overall organizational improvement.

You will operate with a high degree of autonomy, and lead with accountability projects from concept to commercialization. A proactive approach in identifying opportunity areas and a strong drive for results and overall organizational improvement is essential.

This role requires excellent communication skills to effectively collaborate across functions, influence stakeholders and ensure alignment with organizational goals. The Principal Engineer must take responsibility for technical mentorship and coaching, fostering technical growth and knowledge of junior engineers while strengthening the team’s technical capabilities. As a recognized expert, you will guide internal and external teams on the application of packaging standards (e.g., CCIT, ISO 11607, USP , USP , etc.), and represent the company in regulatory interactions, technical forums, and industry partnerships.

Success requires exceptional problem-solving skills, strategic influence, and proven ability to align cross-functional teams toward breakthrough innovation. This role is accountable for delivering measurable outcomes and ensuring that packaging innovations translate into tangible business impact.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Technical Leadership, Data Analysis and Interpretation

• Demonstrate strong ownership and leadership on technical strategies and problem solving while driving projects from concept to commercialization.
• Own the technical roadmap for packaging innovation and ensure alignment with business priorities.
• Take responsibility for the accuracy, integrity, and impact of technical data used to inform decisions.
• Design and direct meaningful and robust research projects or experiments both internally and externally through relationships with academic institutions and industry partners.
• Facilitate knowledge sharing and foster collaborative research initiatives while mentoring, coaching and guiding junior engineers.
• Analyze experimental data to draw meaningful conclusions from research and guide further development.
• Ensure robust statistical methods are applied where necessary.
• Develop innovative solutions to address technical challenges.
• Act as subject matter expert in packaging for FDA regulated products (expert in packaging standards such as CCIT, ISO 11607, USP , USP , etc).
• Identify, scope and represent the organization at key conferences, seminars and other professional events.
• Stay current and keep stakeholders updated with emerging technologies, regulatory trends, and scientific advancements in packaging.

Innovation and Strategy

• Exhibit a proactive mindset in identifying, vetting and implementing new opportunities for innovation and improvement of the organization.
• Demonstrate ability to think strategically and influence the organization on key initiatives.
• Champion initiatives that deliver quantifiable improvements in product performance, cost efficiency, or regulatory compliance.
• Lead cross-functional teams to bring strategic innovations from concept to launch, ensuring accountability at each stage.
• Develop and execute innovation strategies aligned with business goals, including new technologies, methods, and IP creation.
• Lead the development of new products, technologies, and methods that deliver measurable impact and enhance organizational success.
• Assess and take necessary actions to acquire new in-house technologies to improve PDI’s capabilities.

Project Scoping and Ownership

• Define, communicate and align project goals and request necessary resources for execution cross functionally.
• Hold self and cross-functional teams accountable for meeting project milestones, quality standards, and business objectives.
• Ensure post-launch evaluation and continuous improvement based on performance metrics.
• Demonstrate strong interpersonal and influencing skills to drive initiatives forward and overcome challenges.
• Ensure accountability to milestones and objectives while demonstrating strong ownership, coordination and leadership in project execution, anticipating risks, and implementing mitigation strategies to ensure timely and high-quality delivery.
• Demonstrate excellent communication skills in preparing and presenting progress updates, status, reports and findings to senior level management.

PERFORMANCE MEASUREMENT

• Packaging Leadership and Effectiveness: leads packaging design development that meets intended performance, safety and regulatory requirements
• Project Acceleration and Execution: Demonstrates initiative in shaping project direction, anticipating potential obstacles and proposing solutions to ensure timelines are met or accelerated. Consistently delivers technical work on time, in scope and aligned to evolving business priorities
• Strategic Technical Problem Solving: Anticipates and identifies complex packaging development challenges early, leveraging expertise and leadership to drive resolution paths with minimal rework and high technical rigor.
• Cross-Functional Influence and Alignment: Actively engages and influences cross-functional partners (Regulatory, Marketing, Operations, Quality) to ensure clarity of technical direction, ensure alignment and provide technical strategies, expertise and data to remove barriers impeding project progress
• Pipeline Advancement and Opportunity Identification: Proactively scans internal and external landscapes to identify new opportunities, unmet needs and technology enablers that can strengthen the pipeline and move concepts into development
• Performance will be evaluated based on the ability to deliver projects on time, within scope, and with measurable business impact.
• Expected to take full ownership of assigned initiatives and proactively resolve barriers to success.

QUALIFICATIONS

EDUCATION/CERTIFICATION

• Bachelor’s degree in Packaging, Mechanical Engineering, or related scientific discipline required. Advanced degree preferred.

REQUIRED KNOWLEDGE

• New Product development and leadership in a regulated environment.
• Packaging development for FDA regulated products.

EXPERIENCE REQUIRED

• 8+ years of relevant experience in product development and R&D support, with a demonstrated track record of scientific and packaging development responsibilities.

SKILLS/ABILITIES

• Strong analytical thinking capabilities and mindset
• Strong sense of accountability and commitment to delivering results with excellence and timeliness
• Excellent communication and interpersonal skills
• Ability to make sense of, organize and present complex information
• Proven ability to work independently and take initiative in ambiguous or evolving environments
• Ability to set specific goals for self and others and organize/align the resources to help achieve goals
• Demonstrated ability to manage multiple projects with varying complexity
• Ability to evolve, learn and implement new systems and programs
• Initiative taker, ambitious and driven
• Resourceful and able to find creative and innovative ways to achieve results
• Demonstrated accountability for project outcomes and ability to drive initiatives to successful completion.
• Proactive leader who takes full ownership of challenges and drives results with urgency and precision.

WORKING CONDITIONS

• Mix of lab, manufacturing and office environment

SALARY RANGE:

• $128,000 - $141,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

Our pharmaceutical client is seeking a Principal Scientist who will be responsible for evaluating and interpreting analytical results, as well as developing, validating, and transferring analytical methods for APIs, intermediates, and raw materials. If you are someone who wants to be apart of a highly technical environment with a lot of growth, this role may be the one for you!

Responsibilities:

• Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency testing.
• Coordinate off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed.
• Qualify reference materials.
• May also perform other duties as required.

Qualifications:

• Ph.D. in Chemistry or related field with minimum 6 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 14 years of experience in lab environment, pharmaceutical experience preferred.

• Assist hiring managers in defining their strategic workforce needs as a foundation for understanding recruitment objectives. As well as defining the qualities, characteristics and KSAs for positions open for recruitment.
• Reviews search strategies with MVHS hiring managers to determine sourcing options for talent stream development, developing and leveraging appropriate sourcing approaches and methods to develop the sourcing talent pool of high match candidates.
• In collaboration with the Talent Acquisition/Sourcing Specialist and the hiring manager, writes talent sourcing campaign materials specific to each individualized search, and targeted to high potential candidates from a ‘candidate value’ perspective. Reviews campaign materials with manager prior to posting.
• Daily tracks and reviews candidates received through sourcing methods for match with position specifications for each search campaign, and timely reaches out to applicants and managers regarding potential candidacy for each search.
• Routinely confers with hiring manager(s) on talent campaign status and slate of available candidates to assess effectiveness of talent campaign, updating and improving campaign approaches and methods as needed.
• Assist hiring manager in scheduling individual or team behavior interviews, preparing interview guides and scoring guides as needed. Assist in training behavioral interview teams on interview process, legal issues involved in interviewing, and on utilization of interview and guides to evaluate candidates’ potential for performance against expectations.
• Serves as routine contact for applicants and candidates in assigned areas to ensure high engagement throughout the interview, selection and on boarding process.
• Assesses candidates with hiring manager in preparation for candidate selection, verifying quality selection process.
• Assist the hiring manager in continuing onboarding contacts with selected candidate, including supervisor and team welcome note, pre-orientation onboarding material, orientation information, and other related candidate engagement interactions.
  

• Bachelor’s degree from an accredited University in business administration, HR or closely related field.
• An associate degree in business administration, HR or closely related field along with four (4) years of direct experience in healthcare recruitment may substitute for a bachelor’s degree.
• Minimum one (1) year recruitment experience
  

• PRC certification
• CIR/ACIR and/or CSSR/CSMR certification
  

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

• Perform routine QC release and stability testing using HPLC methods including RP-HPLC, SEC, and IEX.
• Prepare samples, operate Agilent HPLC systems, verify system suitability, and ensure analyses meet method and specification requirements.
• Execute complementary analytical assays such as UV-Vis, pH, surface tension, and mechanical tests.
• Maintain complete, accurate documentation in compliance with cGMP, ALCOA+, and data integrity requirements.
• Conduct routine instrument care (solvent flushes, column care, daily checks) and assist troubleshooting under supervision.
• Process and review chromatographic data in Agilent OpenLab CDS.
• Support method qualification, validation, and transfer activities by executing protocols and recording observations.
• Maintain calibration, maintenance, and service records for analytical instrumentation.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related field with 1–3 years of experience; or a master’s degree with relevant laboratory experience.
• Hands-on experience operating HPLC systems; Agilent systems and OpenLab CDS experience strongly preferred.
• Practical experience with chromatographic techniques including RP-HPLC, SEC, and IEX.
• Experience supporting QC release or stability testing in a GMP/GLP environment.
• Strong attention to detail and ability to follow SOPs precisely.
• Excellent documentation practices and understanding of data integrity.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Work Shifts

9:00 A.M – 5:00 P.M

Duties & Responsibilities

Purpose of Position:

Under varying degrees of direction, with broad latitude for the exercise of independent judgment, acts as an expert consultant and advisor on complex and important management problems, with particular reference to business organization and methods. All personnel perform related work.

Examples of Typical Tasks:

Under direction, performs the following typical tasks:

1. Provides expert consultant services for the use of executives, department heads, other departmental personnel, and to inter-corporate facilities or City-wide committees on business organization and methods, and the establishment and implementation of programs for the evaluation, improvement and regularization of normal business operations.

2. Engages in research on business organization and methods to assist in the development and installation of methods and techniques of general application in wide areas of departmental determination and execution or achievement of management policies, objectives and goals.

3. Prepares or supervises the preparation of reports on departmental organization and administration of normal business operations in the light of study and analysis of surveys designed to secure optimum efficiency, economy and adequacy of public service and convenience.

4. Conducts or supervises the conduct of special studies of assigned complex and important management problems.

5. Participates in the establishment and maintenance of effective cooperation and liaison with executive personnel in City departments and agencies, other government agencies and private agencies concerning problems and activities in the area of business organization and methods or the conduct of special studies of management problems.

Minimum Qualifications

1. A Master's degree in public administration or business administration, or in an equivalent or equally acceptable program, and four (4) years of satisfactory, full-time paid experience in a major governmental agency or large corporation or foundation in management analysis or in operational direction, planning, coordination or control of which two (2) years must have been in a supervisory, administrative or consultative capacity; or

2. A Baccalaureate degree from an accredited college or university and five (5) years of experience as stated in #1 above of which three (3) years must have been in a supervisory, administrative or consultative capacity; or

3. A satisfactory equivalent, however, all candidates must possess not less than the two (2) years of supervisory, administrative or consultative experience required.

Four (4) years of appropriate general experience may be substituted for a Baccalaureate degree requirement. Appropriate full-time teaching experience in an accredited college or university may be substituted on a year-for-year basis for the required general experience and appropriate full-time teaching experience in a position of professional rank may be substituted on a year-for-year basis for the required supervisory, administrative or consultative experience.

Department Preferences

Educational Level:

• Graduate Degree

Special Equipment/Machines Operated:

• MS Office
• Peoplesoft Financials
• FMS

Knowledge, Skills, Abilities and other Requirements:

• Capital Eligibility
• Financial Analysis and Controls
• Strong Written and Verbal Communication Skills
• Excellent Customer Service to internal Stakeholders
• Detailed Oriented and Organized

Job Summary

Provide analytical support and data generation for daily chemistry testing activities related to raw materials, in- process and finish products. Perform all testing in a timely and accurate manner in accordance with approved GMP documents (test methods, Specifications, SOPs).

Chemist I

Essential Functions:

• Inspects components, products and/or processes to ensure conformance with standards.
• Executes laboratory procedures for sample preparation
• Performs materials analysis of substantial variety & complexity using ARx test methods, compendia methods, specifications with minimal supervision.
• Ensure all analytical operations comply with cGMPs & ARx procedures and all laboratory experiments are properly documented in notebook and are in accord with regulatory requirements.
• Provide support to routine USP water and environmental testing.
• Works with minimal supervision/direction in expediting completion of laboratory assignments.
• Abide by the ARx Laboratory Chemical Hygiene Plan and other safety policies. Maintains a safe and clean work environment, notifying the supervisor of unsafe practices, conditions, or acts; L-II takes on increasing responsibility for surfacing and implementing improved safety practices.
• Responsible for following all applicable waste handling procedures.

Additional Responsibilities:

• Completes required paperwork / documentation accurately, neatly and in a timely manner.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
• Performs other duties and responsibilities as assigned.
• Make identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established ARx guideline consistent with all regulatory requirements. Actively complies with and endorses Department and Company objectives.

Job Specifications:

• BS (or higher) degree in Chemistry, Microbiology, or closely related discipline and 0-2 years lab experience (preferably pharmaceutical GMP) or requires high school education and 5 years minimum lab experience (preferably pharmaceutical GMP).
• Knowledgeable in the application of various analytical techniques such as chromatography and spectroscopy; thermal analysis and wet chemistry techniques desired.
• Basic knowledge and understanding of scientific principles involved in the performance of analytical test methods.
• Ability to efficiently utilize time (coordinate several assignments concurrently).
• Ability to read and interpret documents such as test methods and procedure manuals.
• Knowledge of requirements for maintaining proper laboratory otebook documentation
• Must have above average computer skills and knowledge; specially in the operational use of analytical equipment have a computer interface.
• Ability to perform basic mathematical functions and apply basic concepts such as mean and standard deviation.
• Good communication skills (verbal and written).
• Excellent interpersonal skills.
• Requires common physical characteristics and abilities, such as above average agility and dexterity; physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching or similar activities should be expected.
• Work environment involves moderate risks or discomforts requiring special safety precautions, will be required to use personal protective equipment.

Physical Demands:

Sitting: 67-100%/day

Standing: 67-100%/day

Walking: 67-100%/day

Kneeling: 1-33%/day

Reaching: 1-33%/day

Overhead Reaching: 1-33%/day

Crawling: Never

Twist/Pivot at Waist: 1-33%/day

Bending: 1-33%/day

Upward Gaze: 1-33%/day

Downward Gaze: 1-33%/day

Squat: 1-33%/day

Balance: Rarely

Light Grasping: 1-33%/day

Heavy Grasping: Rarely

Fine Motor: 1-33%/day

Foot Pedal: Rarely

Hand Controls: 34-66%/day

Lab Assistant – Dover, DE

Contract: 3 months, contract-to-hire

Pay Rate: $24–$26/hr. DOE

Must-Have Skills: LC-MS, GC-MS, and sample preparation

Job Description Summary

The Instrument Readiness Specialist provides operational and technical support for LC-MS, HPLC, and GC-MS laboratories at Customer facilities in Delaware. This role includes routine instrument operation, sample preparation support, preventive maintenance, performance monitoring, and compliant documentation following Customer SOPs, validated methods, and regulatory requirements.

The position requires strong attention to detail, the ability to work independently in a laboratory environment, and effective collaboration with Customer scientists and project stakeholders to ensure reliable analytical operations.

Job Responsibilities

• Provide hands-on operational support for LC-MS, HPLC, and GC-MS instrumentation at Customer facilities, including the DuPont Experimental Station (Wilmington, DE) and New Castle, DE, following SOPs, validated methods, and compliance requirements.
• Perform routine operation of analytical systems: instrument startup/shutdown, method loading, sequence/sample queue setup, data acquisition, and basic system checks.
• Support sample preparation activities: dilution, extraction, filtration, derivatization (as applicable), reagent preparation, consumable selection, and proper sample labeling per Customer-approved procedures.
• Monitor and assess instrument performance: chromatographic stability, pressure/flow profiles, vacuum system performance, detector response, ion source condition, mass accuracy, and column integrity; promptly communicate deviations or abnormal trends.
• Conduct routine preventive maintenance and system upkeep: solvent/mobile phase preparation, degassing, tubing/fitting inspection, leak checks, column flushing, injector/ion source cleaning, vacuum pump monitoring, tuning verification, and routine calibration per manufacturer and Customer requirements.
• Support day-to-day lab operations: equipment readiness, workflow coordination, and effective communication with project leads and local stakeholders.
• Comply with all site-specific safety, laboratory access, emergency response, and environmental health requirements; participate in required safety, EHS, and instrumentation training programs.
• Maintain accurate documentation of instrument usage, maintenance activities, experimental observations, deviations, and corrective actions per Customer practices and data integrity standards.
• Prepare analytical summaries, instrument performance logs, and status updates as requested.
• Ensure proper archiving of raw data, chromatographic results, mass spectral files, electronic logs, and supporting documentation within Customer systems.
• Document and escalate deviations, nonconformances, or unexpected findings promptly; support quality assurance, audit readiness, and inspection activities as requested.

Note: Management reserves the right to assign or reassign duties at any time.

Critical Skills

• Working knowledge of LC-MS, HPLC, and GC-MS instrumentation and laboratory workflows
• Ability to operate analytical instruments according to SOPs, validated methods, and compliance requirements
• Strong attention to detail and commitment to data integrity
• Ability to monitor instrument performance, identify deviations, and escalate issues
• Hands-on experience with routine instrument maintenance, troubleshooting, and preventive care
• Strong organizational and time-management skills in a fast-paced laboratory environment
• Ability to follow instructions and adhere to established procedures
• Effective communication and collaboration with scientists, vendors, and site stakeholders
• Ability to work independently while supporting team objectives

Basic Qualifications

One of the following education and experience combinations:

• Bachelor’s degree in chemistry, biology, biochemistry, or related discipline + 3+ years of relevant lab experience supporting analytical instrumentation
• Associate’s degree in a scientific/technical discipline + 5+ years of hands-on experience supporting LC-MS, HPLC, or GC-MS systems
• High School diploma or GED + 7+ years of directly related laboratory experience in an analytical environment

Additional Requirements:

• Basic proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)

Preferred Qualifications

• 5+ years supporting LC-MS, HPLC, and/or GC-MS in industrial, academic, or regulated labs
• Master’s degree in chemistry, analytical science, or related discipline
• Experience in SOP-driven or regulated labs (GLP, GMP, or similar)
• Familiarity with analytical data systems, ELNs, and data archiving
• Demonstrated ability to support audits, inspections, or QA activities

Working Environment

• Work in laboratory and controlled environments requiring PPE (lab coat, safety glasses, etc.)
• Fast-paced environment with high job completion demands
• Stationary work >25% of the time; occasional movement between labs, corridors, adjoining rooms, and buildings
• Frequent bending, squatting, stretching, and reaching for instrument operation
• Occasionally lift/move up to 25 pounds (potential up to 50 pounds)
• Vision requirements: close-range observation, color vision, peripheral vision, depth perception, ability to adjust focus
• Occasional use of computers and office machinery
• May handle hazardous waste per regulations
• Exposure to lab hazards: extreme temperatures, biological materials, hazardous chemicals
• May require medical clearance, respiratory protection training, and respirator fit testing