New · posted Nov 8
Amgen · Biotechnology
Associate QC I
- Holly Springs, NC
- On-site
- Full-time
- Associate & Specialist
What you need
Basic Qualifications
- High school/GED + 2 years of Quality work experience OR
- Associate’s + 6 months of Quality work experience OR
- Bachelor’s
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vestal professional we seek is an effective leader with these qualifications.
Preferred Qualificationsnice to have
- Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
- 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
- Strong knowledge of laboratory techniques.
- Proficient in the use of LIMS & LMES/CIMS.
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
- Strong written and verbal communication skills including technical writing and presentation.
- Experience with equipment and method validation, verification, and transfer including the change control process.
- Interact effectively with variety of communication and working styles and ability to work well in teams.
What you'll do
Let’s do this. Let’s change the world. In this vital role you will be responsible for supporting the Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The Senior Associate QC Chemistry will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.
Under minimal supervision, the successful candidate will support the startup of the QC organization by:
- Participating in the QC Chemistry start up activities including execution of system qualification and validation and method transfers.
- Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
- Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
- Review and Approve QC method executions for GMP and Stability support.
- Assisting with procurement activities for consumables and critical reagents for routine lab activities.
- Ensure execution and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
- Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
- Support routine activities over the weekends and public holidays as required.
Pay and benefits
$63,000 – $85,000 a year
Employer provided62,571.90USD -84,656.10 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
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 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in North Carolina5 roles publishing pay
Associate & Specialist roles in the US89 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $63,000 | — | $85,000 |
| North Carolina (middle half) | $65,500 | $74,000 | $81,000 |
| All US (middle half) | $62,500 | $72,000 | $88,500 |
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 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 261 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Career resources on Quality Control
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods8
- Collaboration and leadership6
- GMP and compliance4
- Validation and qualification4
- Data and digital systems3
- Documentation and SOPs2
- Quality systems and risk1
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 two 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 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
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- 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
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- 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
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
Company hiring pulse
Amgen on Regulatory Jobs
- 55
- Open roles
- 55
- Distinct roles
- 5
- Locations
By discipline
- Quality31 55%
- Regulatory13 23%
- Clinical12 21%
By level
- Manager20 36%
- Senior & Principal17 30%
- Director13 23%
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Associate QC I at Amgen
Applications close November 11. $63K–$85K a year, employer provided.