Description
The QA Specialist will be a member of the plant QA team, that will provide on-the-production-floor support for the start-up activities, new product introductions and commercial manufacturing associated with unit operations in component preparation, formulation, syringe filling, and inspection.This person will serve as the Quality reviewer and approve batch documentation, non-conformance and CAPA documentation, change control documentation, maintenance work order and job plan approval and other GMP documents.
This position requires the ability to work shifts in support of the production schedule.
Key Responsibilities:
. Provide Quality representation for triage of non-conformance (NC) events
. Review and approve cGMP records (eg electronic batch record, change controls, design qualifications, SOP)
. Collaborate with operations to resolve compliance discrepancies
. Review production batch records in Real Time
. Interact with internal & external regulatory agencies and provide technical expertise as necessary during audits/inspections
. Participate in site activities associated with QMS programs (eg Validation, Complaints, and Change Control)
. Review and approve Master Batch Records
. Collaborate with CAPA owners to ensure CAPA actions address root cause and implementation plan dates are achievable
. Provide Quality oversight of change control records and ensure scope of record is clear and implementation activities are completed according to plan
Basic Qualifications
. University degree. Engineering or Science related discipline preferred
. Significant experience (8yrs +) working in the pharmaceutical or biotechnology industry
. Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
. Possess key competencies: Team Work, Flexibility, Coaching and Motivation, Role Model
If this is you please apply today.