Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)
BioSpace, New Albany, OH, United States
Sr. Associate Plant QA Night Shift
Provide QA guidance and support to AOH production, reviewing quality batch records for all commercial batches labeled and packed at AOH and supporting QA related projects and systems.
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 the first point of contact for production queries during packaging and labeling operations.
Lead, mentor, and coach personnel on quality matters, driving a site-wide quality culture.
Review and approve batch production records and other GMP documentation prior to production activities.
Perform finished product checks during commercial production runs.
Compile and review batch records for lots assembled, packaged, and labeled at AOH, preparing 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 support internal and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Adhere to safety rules, maintaining a safe work environment for all personnel.
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 in a relevant field
Preferred Qualifications
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Experience in GMP/GCP operations or a similarly regulated industry
Affinity with digital innovation, data sciences, and Quality engineering
Experience with raw material receipt, inspection & sampling
Strong verbal and written communication skills; excellent interpersonal skills
High attention to detail and accuracy in GMP documentation
Capability to complete tasks autonomously, providing updates to senior management and identifying potential issues
Strong organizational skills with ability to follow assignments through to completion
Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS, etc.
Salary and Benefits
Exp. annual salary range for this role in the U.S. is posted and will vary based on experience and qualifications. The total rewards plan includes health and welfare plans, financial planning options, work/life balance initiatives, career development opportunities, retirement and savings plans, group medical/dental/vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, stock-based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible.
Equal Employment Opportunity & Accommodations
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, or disability status. Individuals with disabilities will receive reasonable accommodation to participate in the job application or interview process and perform essential job functions.
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Provide QA guidance and support to AOH production, reviewing quality batch records for all commercial batches labeled and packed at AOH and supporting QA related projects and systems.
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 the first point of contact for production queries during packaging and labeling operations.
Lead, mentor, and coach personnel on quality matters, driving a site-wide quality culture.
Review and approve batch production records and other GMP documentation prior to production activities.
Perform finished product checks during commercial production runs.
Compile and review batch records for lots assembled, packaged, and labeled at AOH, preparing 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 support internal and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Adhere to safety rules, maintaining a safe work environment for all personnel.
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 in a relevant field
Preferred Qualifications
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Experience in GMP/GCP operations or a similarly regulated industry
Affinity with digital innovation, data sciences, and Quality engineering
Experience with raw material receipt, inspection & sampling
Strong verbal and written communication skills; excellent interpersonal skills
High attention to detail and accuracy in GMP documentation
Capability to complete tasks autonomously, providing updates to senior management and identifying potential issues
Strong organizational skills with ability to follow assignments through to completion
Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS, etc.
Salary and Benefits
Exp. annual salary range for this role in the U.S. is posted and will vary based on experience and qualifications. The total rewards plan includes health and welfare plans, financial planning options, work/life balance initiatives, career development opportunities, retirement and savings plans, group medical/dental/vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, stock-based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible.
Equal Employment Opportunity & Accommodations
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, or disability status. Individuals with disabilities will receive reasonable accommodation to participate in the job application or interview process and perform essential job functions.
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