Specialist QA

We are seeking a highly motivated Quality Assurance (QA) Specialist to support quality systems and manufacturing operations in a regulated pharmaceutical or biotechnology environment. This individual will be responsible for reviewing and approving key documentation, ensuring compliance, leading investigations, and supporting facility and system validations under minimal supervision.

Key Responsibilities :

• Review and approve Master Production Records (MPs) and process validation protocols and reports.
• Approve planned incidents , environmental characterization reports , and sanitary utility system releases.
• Participate in incident triage and serve as QA representative on New Product Introduction (NPI) teams.
• Lead and support deviation investigations , CAPAs , and change control evaluations.
• Review and approve risk assessments , work orders , and EMS / BMS alarm responses .
• Oversee lot disposition and authorize batches for shipment.
• Represent QA in internal audits , cross-functional meetings, and compliance reviews.
• Own and maintain site-level quality procedures and participate in quality governance forums.
• Support automation , facilities , and environmental monitoring programs.
• Act as QA delegate in local change control review boards when required.

Key Competencies :

Requirements

Required Qualifications :

Preferred Qualifications :

Benefits