Sr Associate PQA

Senior Associate Quality Assurance What You Will Do

Lets do this. Lets change the world. At Amgen, our mission is simple yet powerful: to serve patients. At our Ohio site, you’ll play a critical role in ensuring the highest standards of quality in the products that impact lives around the world. We’re looking for a Senior Associate in Quality Assurance who brings energy, precision, and a passion for excellence to our growing team.

If you thrive in a fast-paced, regulated environment and enjoy solving complex challenges, this is your opportunity to make a meaningful difference.

As a Sr. Associate in QA, you will be a key player in maintaining compliance and driving quality across manufacturing operations. Your responsibilities will include:

• Providing on-the-floor QA support for manufacturing activities across assigned shifts
• Ensuring adherence to GMP regulations and internal quality standards
• Reviewing and approving batch records, logbooks, and quality documentation
• Supporting deviations
• Partnering cross-functionally with Manufacturing, QC, and Engineering teams
• Identifying opportunities for continuous improvement and operational excellence
• Acting as a quality advocate, promoting a culture of compliance and accountability

Position will train on first shift and then move to a shift structure. Possible shifts are 12 hour am, 12 hour pm, second or third shift, and/or one weekend day.

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

• High school/GED + 4 years quality work experience
• Associates + 2 years quality work experience
• Bachelors + 6 months quality work experience
• Master's

• Bachelors degree in Life Sciences, Engineering, or related field
• 1+ years of experience in Quality Assurance within a GMP environment (biotech/pharma preferred)
• Strong knowledge of cGMP regulations and industry best practices
• Experience with batch record review, and deviations
• Ability to work flexible shifts, including evenings, nights, weekends, or holidays as needed
• Excellent communication, problem-solving, and organizational skills
• A proactive mindset with a strong attention to detail

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 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:

• 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.

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.

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.