Quality Assurance Investigator

Details:

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

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com

EOE/F/M/Disability/Veteran