Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)
Amgen, New Albany, OH, United States
Sr. Associate Plant QA Night Shift
The Senior Associate Plant QA is responsible for providing QA guidance and support to AOH production, performing Quality Batch Record Review of all commercial batches labeled and packed at AOH, and supporting QA related projects and systems. They will work a night shift and collaborate with production operators, line leads, shift 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 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—including 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 and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Adhere to safety rules and maintain a safe work environment for all by supporting EHSS corporate and site goals.
Basic Qualifications
High school/GED + 4 years of Quality and/or GMP Manufacturing experience.
Associate’s degree + 2 years of Quality and/or GMP Manufacturing experience.
Bachelor’s degree + 6 months of Quality and/or GMP Manufacturing experience.
Master's degree.
Preferred Qualifications
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 and 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.
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; 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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan covering health and welfare plans, financial plans, work/life balance, and career development opportunities.
Sponsorship
Sponsorship for this role is not guaranteed.
Equal Employment Opportunity
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
#J-18808-Ljbffr
The Senior Associate Plant QA is responsible for providing QA guidance and support to AOH production, performing Quality Batch Record Review of all commercial batches labeled and packed at AOH, and supporting QA related projects and systems. They will work a night shift and collaborate with production operators, line leads, shift 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 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—including 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 and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Adhere to safety rules and maintain a safe work environment for all by supporting EHSS corporate and site goals.
Basic Qualifications
High school/GED + 4 years of Quality and/or GMP Manufacturing experience.
Associate’s degree + 2 years of Quality and/or GMP Manufacturing experience.
Bachelor’s degree + 6 months of Quality and/or GMP Manufacturing experience.
Master's degree.
Preferred Qualifications
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 and 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.
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; 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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan covering health and welfare plans, financial plans, work/life balance, and career development opportunities.
Sponsorship
Sponsorship for this role is not guaranteed.
Equal Employment Opportunity
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
#J-18808-Ljbffr