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

About the role

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.

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 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 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 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.
• Adhere to safety rules and maintain a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Qualifications

• High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• OR Associates + 2 years of Quality and/or GMP Manufacturing experience
• OR Bachelors + 6 months of Quality and/or GMP Manufacturing experience
• OR Master's
• 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 with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.