Sr Associate Plant QA (12 hour PM 6pm-6:30am)

Role Summary

Senior Associate Plant QA for the Amgen Advanced Assembly and Final Product Operation facility. Part of the Quality Assurance Floor Support team, providing QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area. Supports multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance. Location: New Albany, near Columbus, Ohio (on-site).

Responsibilities

• 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 a first point of contact in case of 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 records 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 Standard Operating Procedures (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.
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Qualifications

• Required: High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• Required: Associate’s + 2 years of Quality and/or GMP Manufacturing experience
• Required: Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
• Required: Master’s degree
• Preferred: Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
• Preferred: Experience in and knowledge of GMP/GCP operations or similarly regulated industry
• Preferred: Affinity with digital innovation, data sciences and Quality engineering
• Preferred: Experience with raw material receipt, inspection & sampling
• Preferred: Highly effective verbal and written communication skills, strong interpersonal skills
• Preferred: Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Preferred: Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
• Preferred: Strong organizational skills, including ability to follow assignments through to completion
• Preferred: Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.

Education

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies (Preferred)