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Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)BioSpace, Inc. • New Albany, Indiana, United States
Postuler Maintenant
XX

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

BioSpace, Inc.
  • US
    New Albany, Indiana, United States
  • US
    New Albany, Indiana, United States
Postuler Maintenant

À propos

Position Senior Associate Plant QA Night Shift
What You Will Do As Senior Associate Plant QA, you will work in a shift system and be responsible for providing QA guidance and support to AOH production. You will perform Quality Batch Record Review for all commercial batches labeled and packed at AOH, and support QA related projects and systems. You will establish effective working relationships with production operators, line leads, shift supervisors, warehouse, facilities, maintenance, and engineering.
Responsibilities
Provide daily guidance and support to production staff regarding compliance with SOPs and Work Instructions.
Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
Act as first point of contact for production queries during packaging and labeling operations.
Lead, mentor, and coach operations and support personnel on quality matters, driving site quality culture.
Review and approve batch production records and GMP documentation; 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 internal and external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives.
Adhere to safety rules and maintain a safe work environment.
Basic Qualifications
High school/GED + 4 years of Quality and/or GMP Manufacturing experience.
Associates + 2 years of Quality and/or GMP Manufacturing experience.
Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience.
Master’s degree in relevant field.
Preferred Qualifications
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies.
Experience with GMP/GCP operations or similarly regulated industry.
Affinity with digital innovation, data sciences, and quality engineering.
Experience with raw material receipt, inspection and sampling.
Strong verbal and written communication and interpersonal skills.
Excellent attention to detail and accuracy in GMP documentation.
Ability to work independently and report to senior management.
Strong organizational skills and ability to follow through assignments.
Direct experience with ERP (SAP), TrackWise, CDOCS, etc.
Benefits
Comprehensive employee benefits package: retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts.
Discretionary annual bonus program.
Stock-based long-term incentives.
Award-winning time‑off plans.
Flexible work models, including remote and hybrid arrangements where possible.
Equal Opportunity Employer 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 perform essential job functions and receive other employment benefits. Please contact us to request accommodation.
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  • New Albany, Indiana, United States

Compétences linguistiques

  • English
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