Quality Assurance Complaint Specialist
3 weeks ago
Our client, a life sciences leader, is looking to bring on a Freelance Quality Assurance Investigator, starting May 2024 for a 6 month contract. Role will be hybrid in Westborough, MA.
Top Skills Needed:
- Pharma background
- Quality Management Systems
- Technical Writing
- Complete management experience
Responsibilities:
- Execute the triage, investigation, and closure of product quality complaints.
- Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.
- Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.
- Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.
- Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers
Requirements:
- Bachelor’s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master’s level program
- Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required
- Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
- Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance
- Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints
If you are interested in and qualified for this role, please forward your resume today
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