Sr. Associate Plant QA 12 Hour Day Shift (6am - 6:30pm)

Amgen•New Albany, OH

About The Position

Amgen is seeking a Senior Associate Plant QA to provide quality assurance guidance and support to AOH production. The role works in a shift system and includes Quality Batch Record Review for commercial batches labelled and packed at AOH, as well as support for other QA-related projects and systems. The position works directly with production operators and leads, shift supervisors, warehouse, facilities, maintenance, and engineering to establish effective working relationships and support compliant operations. The role provides guidance on compliance with Standard Operating Procedures (SOPs) and Work Instructions, monitors GMP operations and quality systems in device assembly and packaging areas, reviews and approves GMP documentation, and supports batch disposition. It also contributes to quality culture, inspections, Lean Transformation, Operational Excellence, and site safety goals.

Requirements

High school diploma/GED and 4 years of Quality and/or GMP Manufacturing experience, or an Associate’s degree and 2 years of such experience, or a Bachelor’s degree and 6 months of such experience, or a Master’s degree.
Highly effective verbal and written communication skills and strong interpersonal skills.
Strong attention to detail and a high degree of accuracy in task execution and GMP documentation.
Ability to complete tasks autonomously, provide updates to senior management, and identify potential issues.
Strong organizational skills, including the ability to follow assignments through to completion.

Nice To Haves

Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
Experience in and knowledge of GMP/GCP operations or a similarly regulated industry.
Affinity with digital innovation, data sciences, and Quality engineering.
Experience with raw material receipt, inspection, and sampling.
Direct experience with Enterprise Resource Management software such as SAP, TrackWise, or CDOCS.

Responsibilities

Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures and Work Instructions.
Maintain a regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
Serve as the first point of contact for quality-related production queries during packaging and labeling operations.
Lead, mentor, and coach Operations and support personnel on quality matters and promote the site Quality culture.
Review and approve batch production records and other GMP documentation in support of daily operations.
Review 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 SOPs, Work Instructions, and Forms.
Review and approve Deviation, CAPA, and Change Control records.
Participate in self-led inspections and support internal and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Follow safety rules and maintain a safe work environment by supporting EHSS corporate and site goals.