Job ID: JOB_ID_9316
About the Role:
We are seeking a dedicated Quality Assurance Specialist with a strong background in Vendor Quality Management to oversee critical aspects of raw material inventory and quality processes within a leading biopharmaceutical company. This role is essential for ensuring compliance with cGMP standards and maintaining the integrity of the supply chain.
Key Responsibilities:
- Oversee the management of raw material inventory, including segregation, storage, and conducting regular cycle counts to ensure accuracy.
- Review and approve incoming raw material receiving packets, ensuring all documentation is complete and accurate.
- Manage the status of raw materials within the ERP system, reflecting accurate inventory levels and quality attributes.
- Process and manage Vendor Change Notifications (VCNs), Supply Corrective Action Requests (SCARs), and handle raw material-related deviations and change controls.
- Collaborate with suppliers and internal teams to resolve quality issues and implement corrective actions.
- Ensure all activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines.
- Maintain comprehensive and accurate cGMP documentation for all quality assurance activities related to raw materials.
- Work closely with cross-functional teams, including Procurement, Manufacturing, and R&D, to support product development and commercialization efforts.
Required Skills and Qualifications:
- Bachelor’s or Master’s degree in a relevant scientific field (e.g., Chemistry, Biology, Pharmacy, Engineering).
- Minimum of 4 years of experience in Quality Assurance, specifically overseeing Raw Material Inventory Management, Segregation, Storage, and Cycle Count processes.
- Excellent cGMP documentation skills, with a proven ability to maintain detailed and accurate records.
- Prior experience reviewing and approving incoming raw material receiving packets and managing raw material status in an ERP system.
- Demonstrated experience with Vendor Change Notification, Supply Corrective Action Request (SCAR), raw material deviations, and change controls.
- Must have past experience working in established biopharma companies with commercial QA Operations experience.
- Strong understanding of the pharmaceutical/biotech industry regulatory landscape.
- Excellent analytical, problem-solving, and communication skills.
- Must possess a valid LinkedIn profile.
Employment Type:
- USC and GC (US Citizens and Green Card holders only)
Special Requirements
Onsite, USC and GC, Must have Pharma/Biotech industry, Must have valid LinkedIn
Compensation & Location
Salary: $90,000 – $130,000 per year (Estimated)
Location: Boston, MA
Recruiter / Company – Contact Information
Recruiter / Employer: Pharma/Biotech Company
Email: ishek.kumar@steneral.com
Recruiter Notice:
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ishek.kumar@steneral.com with the subject:
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