From BioPharma Consulting JAD Group's posting. “We” and “our” refer to the employer.
The Sr Specialist, Quality Assurance serves as a technical expert supporting quality systems, validation activities, and compliance within a regulated manufacturing environment. This role is responsible for reviewing and approving product documentation, validation protocols, environmental reports, and quality records. The specialist leads investigations, supports cross‑functional teams, and maintains ownership of key quality program procedures to ensure consistent adherence to regulatory and internal standards.
RESPONSIBILITIES
Review and approve product manufacturing procedures (MPs).
Approve process validation protocols and reports for manufacturing processes.
Approve Environmental Characterization reports.
Approve planned incidents and ensure proper documentation.
Release sanitary utility systems in accordance with quality requirements.
Represent Quality on incident triage teams.
Represent QA on New Product Introduction (NPI) teams.
Serve as designee for the QA Manager on the local Change Control Review Board (CCRB).
Collaborate with Manufacturing, Facilities, Utilities, Validation, and Process Development teams.
Lead investigations and ensure timely closure of quality events.
Own and maintain site quality program procedures.
Perform advanced data trending, evaluation, and compliance assessments.
Support audit readiness and interact effectively with regulatory agencies.
SKILLS
Strong knowledge of manufacturing, distribution, QA, QAL, validation, and process development.
Ability to evaluate compliance issues and apply regulatory expectations.
Advanced data trending and evaluation skills.
Strong understanding of validation protocol execution requirements.
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