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Quality Assurance Specialist
2 months ago
Reporting To: Quality Assurance Supervisor or Manager
Key Responsibilities:
- Conducts comprehensive Annual Drug Reviews and Device History evaluations.
- Ensures the maintenance of Regulatory Compliance documentation and external records.
- Oversees Document Control processes, including Records Retention.
- Engages in both internal and external audit activities.
- Participates in Mock product recall assessments.
- Maintains Standard Operating Procedures (SOPs) and Quality Forms as part of Document Control.
- Records and manages customer approval documents to ensure authenticity.
- Participates in Quality Assurance audits and prepares detailed reports.
- Implements changes to specification sheets following approved change control requests.
- Supports the Change Control program and maintains documentation of product and process modifications.
- Updates SOP binders and related documents through approved Change Controls.
- Facilitates Employee training and documentation for EWL.
- Administers the qualification program for suppliers and vendors.
- Supports and oversees approvals for formulary, specifications, and manufacturing records.
- Engages in Mock product recall assessments.
- Manages Records Retention for the Quality Assurance Department.
- Initiates, tracks, and authors Annual Drug Reviews (ADRs) for OTC products and Device History Reviews (DHRs).
- Assists in the organization, review, and maintenance of OTC bulk batch records, Certificates of Analysis (COAs), and formula documents.
- Conducts physical sample retain reviews for ADRs and DHRs.
- Tracks and manages requests for Change Control Notices (CCNs), Defective Material Forms (DMFs), and Deviations, as well as Return Authorizations and Investigations.
Qualifications:
- Minimum of 2 years of diploma program or a 4-year college degree.
- 2 to 3 years of relevant industry experience.
- Prior experience in Pharmaceuticals, Cosmetics, Food, Medical Devices, or related fields.
- Strong Technical Writing skills.
- Proficient in Word, Excel, Access, and other Windows-based applications.
- Excellent record-keeping abilities.
Benefits:
- Medical, Dental, and Vision Insurance.
- Life Insurance coverage.
- 401k matching program.