New · posted Nov 10
Amgen · Biotechnology
Quality Control Team Lead - 2nd shift
- Holly Springs, NC
- On-site
- Full-time
- Senior & Principal
The role
Quality, Compliance, and Readiness
- 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.
Training and Development
- 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.
Laboratory and Equipment Management
- 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.
Continuous Improvement, Technical Support, and Communication
- 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
What you need
Two ways to qualify
High school
+ 4 years of experience
High school/GED + 4 years of Quality Analytical testing experience OR
- or
Associate
+ 2 years of experience
Associate’s + 2 years of Quality Analytical testing experience OR
Basic Qualifications
- Bachelor’s + 6 months of Quality Analytical testing experience OR
- Master's
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Control Bioassay professional we seek is a dynamic, flexible, and driven individual with these qualifications.
Preferred Qualificationsnice to have
- 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.
What you'll do
Let’s do this. Let’s change the world. 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.
Under minimal supervision, the successful candidate will support the QC organization by:
- 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
When assigned as second shift team lead, the Level 4 Specialist will also be responsible for:
Pay and benefits
$79,000 – $107,000 a year
Employer provided78,724.45USD -106,509.55 USD
What you can expect of us
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
Where you'll work
Holly Springs, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Holly Springs, NCWorking conditions
Shift Leadership and Coordination
- 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.
Career Category
Quality
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
From the posting
About Amgen
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Equal opportunity, accessibility and legal noticesAmgen's statements, word for word
Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in North Carolina7 roles publishing pay
Senior & Principal roles in the US51 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,000 | — | $107,000 |
| North Carolina (middle half) | $93,000 | $93,000 | $116,500 |
| All US (middle half) | $89,000 | $95,000 | $109,250 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 256 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 45 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods24
- Collaboration and leadership9
- Documentation and SOPs6
- Validation and qualification6
- GMP and compliance4
- Investigations and CAPA4
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
Company hiring pulse
Amgen on Regulatory Jobs
- 59
- Open roles
- 59
- Distinct roles
- 5
- Locations
By discipline
- Quality35 58%
- Regulatory13 22%
- Clinical12 20%
By level
- Manager20 33%
- Senior & Principal19 32%
- Director13 22%
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Quality Control Team Lead - 2nd shift at Amgen
Applications close November 23. $79K–$107K a year, employer provided.