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Quality Systems and Compliance Specialist
2 months ago
This role involves supporting Quality Systems and Compliance by managing product complaint handling, acting as document control backup, and assisting with regulatory inspection preparation.
Key Responsibilities- Manage product complaint intake and coordination with partners for timely resolution and safety compliance.
- Develop training and assist in revising handling procedures and reporting to maintain compliance standards.
- Act as backup for document control and support regulatory inspection preparation and execution.
- Bachelor's degree in life sciences, chemistry, or engineering with 5+ years in Pharma Quality/Regulatory.
- Skilled in managing product complaint processes and adverse event reporting.
- Knowledgeable about GxP regulatory compliance, including privacy and documentation.
- Experience with Veeva QualityDocs and eQMS preferred.
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
