QA Specialist - I in Foster City, CA at Apex Life Sciences

Date Posted: 7/13/2018

Job Snapshot

Job Description

Description: QA Specialist I


  • 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 Gilead sciences 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.
  • 2+ years of relevant experience in a GMP related industry and a BS.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.