Night Shift Plant QA Specialist — Quality & Compliance

BioSpace

New Albany (OH)

On-site

USD 90,000 - 120,000

Full time

3 days ago

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Benefits offered by this job

Health insurance

Retirement plan

Performance bonus

Stock options

Job summary

Amgen seeks a Sr. Associate Plant QA on the Night Shift to provide QA guidance for AOH production and perform Batch Record Reviews for commercial batches. You will collaborate with production operators, leads, supervisors, and support functions to uphold GMP and quality systems.

The role requires strong QA expertise, experience with GMP manufacturing, and the ability to interact across multiple disciplines. The position emphasizes safety, documentation accuracy, and process improvement.

Qualifications

High school/GED with 4 years QA or GMP manufacturing experience, or an Associate with 2 years, or a BA with 6 months.
Master's degree is considered advantageous for advanced QA roles.
Preference for GMP/GLP regulated industry experience and data-driven quality work.

Responsibilities

Provide daily guidance to Production staff on SOP and work instruction compliance.
Monitor GMP operations in device assembly and packaging areas.
Act as first contact for quality queries during packaging and labeling.
Lead and coach teams on quality matters and promote a site quality culture.
Review and approve batch production records and GMP documents.
Perform finished product checks during commercial production.
Compile batch records for lots manufactured, packaged, and labeled.
Own and approve controlled documents, SOPs, and forms.
Review deviations, CAPAs, and change controls; participate in inspections.
Support Lean and Operational Excellence initiatives; uphold EHSS goals.