New · posted Oct 16
Amgen · Biotechnology
Sr Associate QA - Nights
- West Greenwich, RI
- On-site
- Full-time
- Senior & Principal
Open until filled
What you need
Two ways to qualify
High school
+ 4 years of experience
High school/GED + 4 years Quality Assurance or manufacturing work experience OR
- or
Associate
+ 2 years of experience
Associate’s + 2 years Quality Assurance or manufacturing work experience OR
Basic Qualifications
- Bachelor’s + 6 months Quality Assurance or manufacturing work experience
- Master's
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The agile professional we seek is a good collaborator with these qualifications.
Preferred Qualificationsnice to have
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
What you'll do
Let’s do this. Let’s change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.
Responsibilities Include:
- Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
- Provide Quality oversight during on-the-floor analytical testing.
- Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.
- Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.
- Alert senior management of potential quality, compliance, supply, or safety risks.
- Complete assigned training to permit execution of required tasks.
- Drive operational improvement initiatives, programs, and projects.
- Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals
In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C shift). The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off and receiving an added 15% shift differential.
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 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:
Apply now and make a lasting impact with the Amgen team.
Where you'll work
West Greenwich, RIOn-siteOpen in Maps (opens in a new tab)
More jobs in West Greenwich, RIWorking conditions
Career Category
Operations
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 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. 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 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 · October 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US285 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $82,000 | — | $111,000 |
| All US (middle half) | $104,000 | $122,500 | $137,500 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Documentation and SOPs6
- Collaboration and leadership6
- Lab testing and methods4
- Investigations and CAPA2
- Quality systems and risk2
- Data and digital systems2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amgen on Regulatory Jobs
- 31
- Open roles
- 29
- Distinct roles
- 5
- Locations
By discipline
- Quality22 71%
- Regulatory7 23%
- Compliance & Safety2 6%
By level
- Manager12 39%
- Senior & Principal9 29%
- Associate & Specialist7 23%
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Sr Associate QA - Nights at Amgen
Open until filled. $82K–$111K a year, employer provided.