Sr Associate PQA

Amgen•New Albany, OH

About The Position

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. Senior Associate Quality Assurance What you will do Let’s do this. Let’s 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

Requirements

High school/GED + 4 years quality work experience OR Associate’s + 2 years quality work experience OR Bachelor’s + 6 months quality work experience OR Master's

Nice To Haves

Bachelor’s 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

Responsibilities

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.

Benefits

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.

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