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Quality Assurance Compliance Specialist
2 months ago
Jubilant HollisterStier LLC, a leading pharmaceutical company, is seeking a highly skilled Quality Assurance Compliance Specialist to join our team.
The successful candidate will provide support to our Deviations, Corrective and Preventive Action (CAPA) program, ensuring product compliance and safety.
Key Responsibilities:- Review deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs, policies, and regulations.
- Facilitate deviation investigation and resolution, assessing product impact and completing final assessments for QA Management and client review.
- Enter data into the corporate RCA and CAPA database.
- Provide oversight of investigational RCA group activities, including meeting preparation, publishing meeting minutes, and follow-up on agreed-upon activities.
- Interface with management and responsible individuals to ensure task completion on or before established due dates.
- Support quality systems, processes, and procedures to ensure compliance and product quality and safety.
- Associate's degree in Biology, Chemistry, or a related field, or 5 years of experience in lieu of an Associate's degree.
- Minimum 2 years of experience in the pharmaceutical industry, with experience in technical writing a plus.
Jubilant HollisterStier LLC offers a dynamic work environment, competitive compensation, and opportunities for professional growth and development.