QC Analyst 3
Location: 101 International Drive, Portsmouth, NH 03801
Contract Duration: 8 Months (Potential for Extension or Full-Time Conversion)
Pay Rate: $ 51.09–$ 69.34/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance
Position Summary
The QC Analyst IV will serve as an experienced member of the Quality Control team, supporting the testing and release of in-process and final product drug lots while ensuring accurate, timely, and compliant results. This role will also support testing for ongoing customer stability studies and provide technical expertise across multiple analytical laboratories. The QC Analyst IV will troubleshoot laboratory equipment and analytical processes, support investigations and continuous improvement initiatives, and provide guidance and training to junior analysts. The position operates with general supervision and requires strong knowledge of cGMP, data integrity, laboratory practices, and regulatory expectations.
Key Responsibilities
- Provide technical guidance and feedback to junior QC analysts and support compliance with laboratory procedures and regulatory requirements.
- Delegate and coordinate tasks to support daily QC laboratory operations and ensure testing activities are completed accurately and on schedule.
- Perform and review analytical testing within the HPLC Analytical and Electrophoresis laboratories, with opportunities for cross-training in Immunology and other advanced analytical methods.
- Support the execution and review of advanced assays, including HPLC, UPLC, electrophoresis, spectrophotometry, and other applicable laboratory techniques.
- Maintain laboratory equipment readiness by coordinating maintenance, calibration, troubleshooting, and vendor activities.
- Work with laboratory instruments and systems including HPLC/UPLC systems, pH and conductivity meters, pipettes, SoloVPE, Cary 60 spectrophotometers, PA-800 capillary electrophoresis systems, Protein Simple iCE3/icIEF instruments, 7500 Real-Time PCR systems, KingFisher Flex systems, and Sysmex CS-2500 analyzers.
- Troubleshoot laboratory equipment, software, and analytical issues and escalate complex problems when necessary.
- Identify and implement opportunities for continuous improvement, including 6S initiatives, document revisions, work orders, change controls, and process improvements.
- Collaborate with Manufacturing, Quality Assurance, MSAT, PV, and other cross-functional teams during laboratory and manufacturing operations.
- Initiate and support laboratory investigations, deviations, and other quality-related activities within the scope of assigned responsibilities.
- Drive audit readiness by maintaining laboratory compliance, conducting pre-audit walkthroughs, and serving as a QC subject matter expert during regulatory or customer audits.
- Apply data integrity principles to all laboratory activities in accordance with company policies, procedures, and regulatory expectations.
- Complete assigned work accurately and on time while independently identifying and addressing required tasks.
- Perform other duties and special projects as assigned.
Required Qualifications
Education
- Bachelor's degree in Biochemistry, Chemistry, Biology, or a related scientific discipline.
- Equivalent combination of education and relevant experience may be considered.
Experience
- 5–10 years of relevant industry experience, preferably within a cGMP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
- Experience with QC laboratory operations and analytical testing.
- Experience with laboratory investigations, equipment troubleshooting, documentation, and quality systems.
- Experience working in a regulated environment with strong understanding of cGMP and data integrity requirements.
Technical Skills
- Experience with HPLC and/or UPLC analytical testing and review.
- Knowledge of electrophoresis and related analytical techniques.
- Ability to work with laboratory instrumentation, software, calibration, and maintenance activities.
- Ability to interpret analytical data and identify trends, discrepancies, and potential issues.
- Understanding of laboratory documentation, deviations, change controls, investigations, and audit readiness.
- Strong understanding of data integrity principles and regulatory compliance.
- Ability to troubleshoot analytical equipment and software issues.
- Strong written and verbal communication skills.
- Strong prioritization, organization, problem-solving, and decision-making skills.
- Ability to manage multiple assignments and meet deadlines with minimal supervision.
Preferred Qualifications
- Experience supporting stability testing and/or commercial or clinical manufacturing programs.
- Experience with HPLC, UPLC, capillary electrophoresis, icIEF, PCR, spectrophotometry, or related analytical technologies.
- Experience serving as a laboratory or QC subject matter expert during audits.
- Experience training or mentoring junior laboratory analysts.
- Experience with continuous improvement, 6S, change controls, and laboratory process optimization.
Core Competencies
Agility
- Adapts effectively to changing priorities and new challenges.
- Supports continuous improvement and problem-solving initiatives.
- Demonstrates flexibility when learning new analytical methods and technologies.
Business Acumen
- Uses analytical data and sound judgment to support quality decisions.
- Communicates technical information clearly and effectively.
- Identifies opportunities to improve laboratory operations.
Collaboration
- Works effectively with QC and cross-functional teams.
- Shares technical knowledge and supports the development of other analysts.
- Maintains professional and respectful working relationships.
Customer Focus
- Understands internal and external customer requirements.
- Delivers accurate, timely, and reliable analytical results that support manufacturing and customer commitments.
Driving Results
- Plans, prioritizes, and organizes laboratory activities effectively.
- Consistently meets quality, productivity, and turnaround-time expectations.
- Maintains high standards of accuracy and minimizes rework.
Leadership
- Demonstrates ownership of assigned responsibilities and laboratory quality.
- Acts as a professional role model for other QC analysts.
- Promotes a positive, safe, and compliant laboratory environment.
Quality & Compliance
- Adhere to all applicable cGMP requirements, company policies, SOPs, and laboratory procedures.
- Take ownership of the quality and accuracy of all work performed.
- Promptly communicate regulatory concerns, GMP deficiencies, deviations, product quality issues, and other quality events to appropriate management.
- Maintain complete, accurate, and contemporaneous documentation in accordance with data integrity requirements.
- Support regulatory inspections, customer audits, internal audits, and inspection readiness activities.
Safety
- Follow all site safety policies, laboratory safety procedures, and applicable health and safety requirements.
- Complete required safety training and maintain compliance with site safety expectations.
- Proactively identify and report unsafe conditions, accidents, injuries, and potential hazards.
- Promote a strong safety culture within the laboratory and team.
Key Stakeholders
- QC Biochemistry
- Manufacturing
- Manufacturing Science and Technology (MSAT)
- Pharmacovigilance (PV)
- Quality Assurance (QA)
- Other cross-functional laboratory and operations teams
Work Style
This position works under
general supervision, receiving limited instruction for day-to-day activities and general guidance for new assignments. The QC Analyst IV is expected to exercise sound judgment, work independently within established procedures, and provide technical support to other team members.
Additional Skills & Attributes
- Strong attention to detail and commitment to quality.
- Ability to follow complex written and verbal instructions.
- Ability to work independently while contributing effectively to a team.
- Strong analytical thinking and problem-solving capabilities.
- Ability to prioritize multiple tasks in a fast-paced laboratory environment.
- Professional written and verbal communication skills.
- Self-motivated and dependable.
- Ability to perform complex and varied laboratory assignments.
- Strong commitment to meeting deadlines and maintaining accurate documentation.
#TMCA
