New · posted Nov 6
Amgen · Biotechnology
Sr. Associate Plant QA
- New Albany, OH
- On-site
- Full-time
- Senior & Principal
What you need
Basic Qualifications
High school/GED + 4 years of Quality and/or GMP Manufacturing experience
Associate’s + 2 years of Quality and/or GMP Manufacturing experience
Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
Master's
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with any of these qualifications.
Preferred Qualificationsnice to have
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Experience in and knowledge of GMP/GCP operations or similarly regulated industry
Affinity with digital innovation, data sciences and Quality engineering
Experience with raw material receipt, inspection & sampling
Highly effective verbal and written communication skills, strong interpersonal skills
Great attention to detail and high degree of accuracy in task execution and GMP documentation
Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
Strong organizational skills, including ability to follow assignments through to completion
Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.
What you'll do
Let’s do this. Let’s change the world. In this role As Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at AOH. Next to that, you will provide support in different QA related projects/systems.
In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.
Let’s do this. Let’s change the world. In this vital role you will:
Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
Perform finished product checks during (commercial) production runs
Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.
Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
Review and approve Deviation, CAPA, and Change Control records.
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives
Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.
Pay and benefits
$82,000 – $111,000 a year
Employer provided82,081.95USD -111,052.05 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, including remote and hybrid work arrangements, where possible
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
New Albany, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in New Albany, OHWorking 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.
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 diverse, 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $82,000 | — | $111,000 |
| All US (middle half) | $90,750 | $95,500 | $101,750 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 92 open Quality Operations & Batch Release 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 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Documentation and SOPs7
- Collaboration and leadership3
- Quality systems and risk2
- Investigations and CAPA1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release 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
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- 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
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- 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
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amgen on Regulatory Jobs
- 47
- Open roles
- 47
- Distinct roles
- 5
- Locations
By discipline
- Quality24 51%
- Clinical12 26%
- Regulatory11 23%
By level
- Manager17 36%
- Director13 28%
- Senior & Principal12 26%
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Sr. Associate Plant QA at Amgen
Applications close November 12. $82K–$111K a year, employer provided.