Sr Associate Plant QA Albany, OH

Job Description

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Unless specifically stated otherwise, this role is “On‑Site” at the location detailed in the job post.

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.

In this role as Senior Associate Plant QA, you will work in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and for performing Quality Batch Record Review of all commercial batches labelled and packed  will also provide support in different QA related projects/systems.

In this role, you will be in direct contact with a wide range of partners and will be accountable for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.

• 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 provide oversight to GMP operations and quality systems.
• Act as first point of contact for 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.
• 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 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.
• Adhere to safety rules and maintain a safe work environment for both yourself and others.

Basic Qualifications

• High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• or Associate’s + 2 years of Quality and/or GMP Manufacturing experience
• or Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
• or Master’s

Preferred Qualifications

• 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…