Job Title: QA Specialist
Duration: 1 Year
Location: Foster City, CA 94404
QA Specialist I
2+ years of relevant experience in a GMP related industry and a BS.
- Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients
- Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations
- Provides acknowledgement letters to the complainant upon receipt of complaint
- Notifies appropriate organizations for any product replacement requests from the complainants
- Conducts follow up calls to the reporters as required
- Communicates any Safety events to Drug safety
- Provides general support to the quality systems group including but not limited to database maintenance and report outputs
- Shipment of prepaid FedEx labels to the complainant for sample return
- Performs returned sample receipt, storage and assessment.
- May participate in cross functional complaint related teams
- May perform investigation of minor complaints
- Manages CMO investigation associated with complaints
- Performs authenticity check for returned complaint samples
- Reviews and approved investigation tasks from other Client sites
- May perform basic data analysis in support of complaint investigations, trend reports and APQRs
- Perform reconciliation of Drug Safety events
- Ensure compliance with applicable regulatory requirements with current Good Manufacturing Practices (cGMPs)
- Normally receives general instruction on routine work, detailed instructions on new assignments
- This is an entry-level position requiring working knowledge of quality assurance systems, methods and procedures.
- Assignments range from routine to basic where analysis of situation or data requires a review of simple and fairly identifiable factors.
- Works on assignments that are routine in nature where ability to recognize deviation from accepted practice is required.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Demonstrates good verbal, written, and interpersonal communication skills are required.
- Demonstrates working knowledge in Microsoft Office applications