Quality Control Team Lead - 2nd shift

Amgen • Holly Springs, NC

1d

About The Position

The Quality Control Team Lead performs analytical testing and assists with managing Amgen’s Quality Control Bioassay laboratory. The role supports laboratory startup, testing, method transfers and validation, documentation, daily operations, and quality investigations. It may manage bioassay staff and reports directly to the Senior Manager of Quality Control Bioassay.

When assigned as the second-shift team lead, the Level 4 Specialist leads daily shift operations, coordinates work and handoffs, serves as the first escalation point, and helps ensure testing timelines and laboratory readiness. The role also oversees shift training, equipment and supply readiness, continuous improvement, technical support, and communication with other departments.

Requirements

• High school diploma or GED plus 4 years of Quality Analytical testing experience; or an associate degree plus 2 years; or a bachelor’s degree plus 6 months; or a master’s degree.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Ability to work independently as a project owner, collaboratively on group tasks, and as a trainer.

Nice To Haves

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in immunology, biology, biochemistry, or a related scientific field.
• Experience with cell-based methods and ELISA, with strong data analysis skills.
• Experience with equipment validation.
• Strong knowledge of aseptic technique.

Responsibilities

• Assist with planning and executing Bioassay laboratory equipment installation and qualification.
• Perform QC bioassay analytical testing for biologic products, including ELISA and cell-based methods.
• Lead transfers, qualifications, and validations of complex biologic procedures.
• Author, revise, and review SOPs, safety assessments, methods, trend reports, qualification and validation summaries, technical reports, and method assessments.
• Assist with planning, scheduling, and executing daily laboratory activities.
• Work with external partners on successful transfers, release testing, and stability testing.
• Support Bioassay laboratory operations, including supply ordering and equipment and laboratory-space upkeep.
• Participate in audits, initiatives, and projects with interdepartmental or global scope.
• Own, manage, and participate in deviations, CAPAs, and cross-functional investigations.
• Train junior staff in bioassay techniques and assays; assist with laboratory setup and 5S.
• Support routine work on weekends and Amgen holidays as needed.
• Lead second-shift operations by assigning work, setting priorities, balancing workload, and coordinating shift handoffs and coverage.
• Act as the second-shift escalation point for technical, quality, safety, and equipment issues, escalating to management when needed.
• Monitor sample testing and release or stability timelines and flag risks early.
• Ensure second-shift work meets GMP, ALCOA+ data-integrity, and documentation standards; review records for accuracy and completeness.
• Lead or support deviation notification, containment, investigation, CAPA actions, and effectiveness checks.
• Maintain inspection readiness and confirm staff are trained and qualified on assigned methods.
• Provide onboarding, method training, and competency sign-off; maintain training matrices, identify skill gaps, coach staff, and promote cross-training.
• Oversee equipment readiness, calibration, preventive maintenance, cleaning schedules, and inventory of reagents, consumables, and critical supplies.
• Coordinate equipment qualification, installation, and startup with Engineering, Metrology, and vendors; sustain laboratory 5S.
• Identify and implement operational efficiencies, support method transfers and validation, and trend assay performance to raise recurring issues for investigation.
• Report shift performance metrics to the Senior Manager and partner with Manufacturing, QA, Supply Chain, and Metrology on cross-functional issues.
• Represent the Bioassay laboratory in second-shift tiered or daily huddles.

Benefits

• Retirement and Savings Plan with company contributions
• Group medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability insurance
• Flexible spending accounts
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
• Stock-based long-term incentives
• Time-off plans
• Flexible work models where possible
• Career development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED