Compliance Specialist
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Accentuate Staffing is currently recruiting for a Compliance Specialist with a leading company in Raleigh, NC. This position is expected to help develop, implement, and maintain systems and procedures designed to maintain a high level of internal and external audit readiness and regulatory compliance. The position is responsible for facilitating the approval of the Annual Product Quality Reviews (APQR) and the development of relevant systems designed to maintain compliance with the various APQR procedures and Regulatory Agency requirements.
Responsibilities:
- Participates in multi-functional project teams as a Quality Compliance representative as directed by the CQA Supervisor or Site Quality Head.
- Supports site quality systems including participation in investigation and change control writing, review, and closure, as appropriate.
- Actively participates in the review and approval of GMP documents including, but not limited to procedures, validation protocols, engineering documents, critical work orders.
- Responsible for compiling and reporting metrics related to site compliance efforts.
- Performs the QA review of incoming materials in JDE, as required.
- Responsible for compiling, processing and facilitating the APQR.
- Responsible for maintaining the Approved Supplier List (ASL), Quality Agreements, and applicable duties associated with corporate supplier management.
- Serve as Good Distribution Practices (GDP) responsible person for the Raleigh site with a focus on developing, evaluating and implementing good transportation practices for maintaining product quality and integrity.
- Tracks open records in TrackWise to include Deviations, Environmental Excursions, OOS investigations, CAPAs, and Change Controls to closure. Creates metrics for CAPA effectiveness evaluation.
- Assists in ensuring adherence to regulatory requirements and industry guidance through the review of appropriate documentation and internal audit activities as directed by the Compliance Management team.
- Responsible for the compliance of the storage and archiving of documents with company policies and Regulatory Agency requirements.
- Assists and coordinates compliance initiatives based on new regulations, guidance documents and industry standards as they apply to site Quality Assurance.
- Participates in internal and customer or regulatory audits, as required.
Requirements:
- Bachelor’s Degree and 3-5 years GMP Pharmaceutical experience
- Must have experience as a Technical Reviewer.
- Experience with TrackWise preferred.
- Must have an in depth knowledge of current GMP well as FDA trends and guidelines.
