Compliance Specialist
About the role
The QA Compliance Specialist works with the Compliance Management Team to identify and correct cGMP inadequacies at the Production Unit, develop and implement Quality Systems designed to maintain a high level of internal and external audit readiness, and ensure Regulatory Compliance. The position is responsible for facilitating the approval of the Annual Product Quality Review (APQR) and developing relevant systems to maintain compliance with APQR procedures and Regulatory Agency requirements. The QA Compliance Specialist participates in compliance initiatives based on new regulations, guidance documents, and industry standards, and provides support for event initiation, investigations, and internal audits.
Responsibilities
- Participates in multi-functional project teams as a Compliance representative as directed by the Compliance Management Team
- Responsible for compiling, processing, and facilitating the Annual Product Quality Review in a timely manner
- 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 policy 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 FDA readiness audits as required by the Compliance Management team
- Performs other duties as assigned by Compliance Supervisor, Manager, or Director of Quality Assurance
Benefits
- Medical, dental, and vision coverage
- Life insurance
- Disability insurance
- 401K with company contribution
- Wellness program
Employment is at-will, meaning both the employee and employer have the right to end the employment relationship at any time.