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

Amgen • New Albany, OH

1d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients 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. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr Associate Plant QA (12 hour PM 6pm-6:30am) Live What you will do Let’s do this. Let’s change the world. In this role as Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at AOH. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering. Senior Associate Plant QA – 12 hour PM Shift The Sr. Associate Plant QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area. The Sr. QA Associate will support multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Production, IQA, and other groups, as needed. Advising Production on proper documentation as needed and performing other duties as assigned. This role will require local presence at the New Albany facility near Columbus, Ohio. 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 record and other GMP documentation in support of daily operations. 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 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. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• Provide QA guidance and support to AOH production
• Performing Quality Batch Record Review of all commercial batches labelled and packed at AOH
• Provide support in different QA related projects/systems
• Establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering
• Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Production, IQA, and other groups, as needed.
• Advising Production on proper documentation as needed and performing other duties as assigned.
• 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 record and other GMP documentation in support of daily operations. 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 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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level