Quality Assurance Investigator
6 months ago
Job Title: Quality Assurance Investigator
Location: Westborough, MA
Zip Code: 01581
Start Date: Right Away
Job Type: Contract
Pay Rate: Up to $56.67/hr
Keywords: #QualityAssuranceJobs #PharmaceuticalIndustry
JOB 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
REQUIRED QUALIFICATIONS:
* 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
EOE/F/M/D/V
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