Quality Assurance Specialist

Proclinical is currently recruiting for a Quality Assurance Specialist with a biotechnology company located in St.Louis, MO.

Job Responsibilities:

• Perform Rapid Response and Root Cause Analysis investigations for Quality Incidents in operations with involved operators to ensure full understanding of the incident at the time it occurred.
• Ensure products are produced to the correct specification and per the operating instructions for all markets meeting compliance with registered details and TTS agreements.
• Assist in managing consumer complaint investigations, as required.
• Execute and/or assist in self-inspections and level 2 internal auditing programs.
• To ensure that all batch implicating issues are highlighted and resolved without delay to batch release and/or impact to compliance/regulatory requirements.
• Comply with all operational safety, process safety, environmental permits, Quality policies, procedures and training requirements.
• Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
• Effectively and compliantly write and manage the activities required to execute rework and AQL activities; including training and knowledge of Regional Distribution Center procedures and processes applicable to the site.
• Additional responsibilities include supporting incident and deviation investigations, participation in internal auditing activities, and the management of materials. Additional responsibilities include approving line clearance activities, GEMBA activities, QIR investigations and batch record review assistance as required.

Skills and Requirements:

• High school diploma or equivalent required
• High school diploma is sufficient to manage the job responsibilities and duties within the Quality organization.
• Computer skills and pharmaceutical background.
• Associate degree

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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