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

Amgen•New Albany, OH

23h

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 Night Shift 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 stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.

Requirements

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

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 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. 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

A 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
Flexible work models, including remote and hybrid work arrangements, where possible

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