Quality Control Team Lead - 2nd shift

Amgen•Holly Springs, NC

22h•$78,724 - $106,510

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, routine operations, external method transfers, and testing and release or stability activities for biologic products. The Specialist, Quality Control Bioassay reports directly to the Senior Manager of Quality Control Bioassay; the role may manage bioassay staff. The position operates QC bioassay tests, including ELISA and cell-based methods; leads complex procedure transfers, qualifications, and validations; and authors, revises, and reviews laboratory documents and technical reports. It supports daily work planning, equipment and supply management, audits and investigations, staff training, laboratory setup, and 5S. Routine weekend and Amgen holiday activities may be required. When assigned as the Level 4 second-shift team lead, the specialist leads shift operations, assigns and prioritizes work, coordinates handoffs and coverage, and serves as the initial escalation point for technical, quality, safety, and equipment issues. The lead monitors testing timelines and performance, promotes GMP and data-integrity compliance, reviews records, supports deviations and CAPAs, maintains inspection readiness, and oversees staff training, equipment readiness, inventory, and laboratory organization. The role also supports continuous improvement, method transfers, technical troubleshooting, performance reporting, and coordination with Manufacturing, QA, Supply Chain, Metrology, Engineering, vendors, and other teams.

Requirements

High school diploma or GED and 4 years of Quality Analytical testing experience; or an associate degree and 2 years of Quality Analytical testing experience; or a bachelor’s degree and 6 months of Quality Analytical testing experience; or a master’s degree.
Meet applicable GMP, data-integrity, and documentation standards for laboratory work.
Confirm training and qualification on assigned methods before performing them.

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 ELISAs, 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.
Ability to work flexibly and independently, own projects, collaborate on group tasks, and serve as a trainer.

Responsibilities

Assist with planning and execution of equipment installation and qualification in the Bioassay laboratory.
Operate QC bioassay analytical testing for biologic products, including ELISA and cell-based methods.
Lead transfers, qualifications, and validations for complex biologic procedures.
Author, revise, and review SOPs, safety assessments, methods, trend reports, qualification and validation summary reports, technical reports, and method assessments.
Assist with planning, scheduling, and execution of daily laboratory activities.
Work with external partners to support successful transfers, release testing, and stability testing.
Support Bioassay laboratory operations, including ordering supplies and maintaining equipment and laboratory spaces.
Participate in audits, initiatives, and projects that may have 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 general laboratory setup and 5S.
Support routine activities over weekends and Amgen holidays as needed.
Lead second-shift daily operations, assign work, set priorities, and balance testing workloads.
Lead shift-start and shift-end handoffs with first shift, night shift, and the Senior Manager, communicating testing status, open deviations, equipment status, and pending samples.
Serve as the first point of escalation on second shift for technical, quality, safety, and equipment issues, escalating to management as needed.
Ensure sample testing and release or stability timelines are met, and flag at-risk timelines early.
Coordinate shift coverage and schedule changes, including weekend and holiday support.
Ensure second-shift work meets GMP, ALCOA+ data-integrity, and documentation standards.
Review laboratory notebooks, assay data, and records for accuracy and completeness before release or handoff.
Lead or support initial deviation notification, containment, and investigation, and drive CAPA actions and effectiveness checks to timely closure.
Maintain second-shift laboratory areas in inspection-ready condition and guide inspection walkthroughs as needed.
Confirm staff are trained and qualified on assigned methods before they perform them.
Serve as a primary trainer for new and junior staff, including onboarding, method training, and competency sign-off.
Maintain second-shift training matrices, identify skill gaps, and provide team-development feedback to the Senior Manager.
Promote cross-training to build assay coverage on second shift.
Oversee daily equipment readiness, including calibration, preventive maintenance, and cleaning schedules.
Manage reagent, consumable, and critical-supply inventory to prevent testing interruptions.
Support equipment qualification, installation, and startup with Engineering, Metrology, and vendors.
Drive laboratory organization and sustainment of 5S.
Identify and implement efficiencies, including automation opportunities, scheduling improvements, and reduction of repeat testing.
Support method transfers, qualification, and validation so second shift can execute transferred methods.
Trend assay performance, including invalid runs, OOT/OOS, and system suitability failures, and raise recurring issues for investigation.
Report shift performance metrics, including on-time testing, right-first-time rate, deviation counts, and backlog, to the Senior Manager.
Partner with Manufacturing, QA, Supply Chain, and Metrology on cross-functional issues and represent the Bioassay laboratory in second-shift tiered or daily huddles.