Quality Control Team Lead - 2nd shift

What you will do

In this vital role you perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff.

• Assisting with planning and execution of equipment installation and qualification within the Bioassay lab to support startup.
• Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods.
• Leading transfer, qualification, and/or validation for the complex biologic procedures.
• Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments.
• Assisting with planning, scheduling, and execution of daily activities.
• Working with external partners to ensure successful transfer and release of and stability testing.
• Supporting all operations of the Bioassay lab including the ordering of supplies, maintaining of equipment and lab spaces.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Own, manage, and participate in deviations, CAPAs, and cross functional investigations.
• Training of junior staff in bioassay techniques and assays.
• Assisting with general lab setup and 5S.
• Support routine activities over the weekends and Amgen holidays as needed.

Additional Responsibilities – Level 4 Second Shift Team Lead

• Leading second shift daily operations, including assigning work, setting priorities, and balancing workload across testing.
• Leading shifts start and end handoffs with first shift, night shift and the Senior Manager, covering testing status, open deviations, equipment status, and pending samples.
• Serving as the first point of escalation on second shift for technical, quality, safety, and equipment issues, and escalating to management as needed.
• Ensuring sample testing and release/stability timelines are met and flagging at-risk timelines early.
• Coordinating shift coverage and schedule changes, including weekend and holiday support.
• Ensuring second shift work meets GMP, data integrity (ALCOA+), and documentation standards.
• Reviewing laboratory notebooks, assay data, and records for accuracy and completeness prior to release or handoff.
• Leading or supporting initial deviation notification, containment, and investigation, and driving CAPA actions and effectiveness checks to timely closure.
• Maintaining second shift laboratory areas in a state of inspection readiness and guiding inspection walkthroughs as needed.
• Confirming staff are trained and qualified on assigned methods before performing them.
• Serving as a primary trainer for new and junior staff, including onboarding, method training, and competency sign-off.
• Maintaining second shift training matrices and identifying skill gaps.
• Providing feedback and coaching input to the Senior Manager on team member development needs.
• Promoting cross-training to build depth across assays on second shift.
• Overseeing daily equipment readiness, including calibration, preventive maintenance, and cleaning schedules.
• Managing reagent, consumable, and critical supply inventory to prevent testing interruptions on second shift.
• Supporting equipment qualification, installation, and startup in coordination with Engineering, Metrology, and vendors.
• Driving laboratory organization and sustainment of 5S.
• Identifying and implementing efficiencies, such as automation opportunities, scheduling improvements, and reduction of repeat testing.
• Supporting method transfers, qualification, and validation to ensure second shift can execute transferred methods.
• Trending assay performance (e.g., invalid runs, OOT/OOS, system suitability failures) and raising recurring issues for investigation.
• Reporting shift performance metrics (e.g., on-time testing, right-first-time rate, deviation counts, backlog) to the Senior Manager.
• Partnering with Manufacturing, QA, Supply Chain, and Metrology on cross-functional issues, and representing the Bioassay lab in second shift tiered or daily huddles.

Basic Qualifications

• High school/GED + 4 years of Quality Analytical testing experience OR
• Associate’s + 2 years of Quality Analytical testing experience OR
• Bachelor’s + 6 months of Quality Analytical testing experience OR
• Master's

Preferred Qualifications

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in immunology, Biology, Biochemistry, or related scientific field.
• Experience with cell-based methods and ELISA’s, with strong data analysis skills.
• Experience with equipment validation.
• Strong knowledge of aseptic technique.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.