Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)

Role Summary

Sr. Associate Plant QA Night Shift (6pm–6am) at Amgen. Provide QA guidance and support to AOH production, perform Quality Batch Record Review of all commercial batches labelled and packed at AOH, and support QA-related projects/systems. Works with a wide range of stakeholders to establish effective working relationships with production operators, line leads, supervisors, warehouse, facilities, maintenance, and engineering.

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 monitor GMP operations and quality systems.
• Act as a 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, driving the site Quality culture.
• Review and approve batch production records and other GMP documentation in support of daily operations; perform 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 provide support during internal/external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives.
• Adhere to safety rules and maintain a safe work environment in line with EHSS goals.

Qualifications

• 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 GMP/GCP operations or similarly regulated industry
  • Affinity with digital innovation, data sciences and Quality engineering
  • Experience with raw material receipt, inspection & sampling
  • Strong verbal and written communication, interpersonal skills
  • Attention to detail and accuracy in GMP documentation
  • Ability to complete tasks autonomously and provide updates to senior management
  • Strong organizational skills and follow-through
  • Direct experience with ERP software (SAP), TrackWise, CDOCS, etc.

Skills

• Quality assurance and GMP documentation
• Documentation control and compliance
• Problem solving and corrective actions (CAPA)
• Communication and stakeholder collaboration
• Attention to detail and accuracy in recordkeeping
• ERP systems familiarity (SAP, TrackWise, CDOCS)

Education

• As specified in qualifications (degrees as listed above)