Summary

Our client, a biotechnology company, is seeking a highly motivated person for the role of QA Specialist II- Quality Management Systems. This individual will be responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements and reports to Senior Manager of Quality Assurance.

Duties / Expectations of Role

· Support activities related to Quality Management System (QMS).

•  Performing tasks and troubleshooting of all activities in electronic systems for Quality Management Systems (Agile, Veeva, LMS and equivalent).
• Product Complaints and Returns – support investigations in cooperation with Senior Manager of QA, Regulatory Affairs, and other departments.
• Deviations, Investigations, Root Cause Analysis, Laboratory Investigations and Out-of-Specifications for the site - ensure timely initiation by the representative department; evaluation, review, and QA approval of investigations to ensure completion is appropriate to the level/ classification of discrepancy.
• Change Controls – support initiation, evaluation, and completion to ensure timely and satisfactory implementation of changes by all departments at the site.
• CAPA program - support and monitor all CAPAs to ensure implementation is completed according to the established procedures and policies.
• Support and back up for Document Control and Learning Management Systems for the site.
• Provide information for Product Quality Reviews and participate in review of PQRs.
• Provide information for metrics related to QMS and Compliance in support of the Management Review.
• Support activities for Gap Analysis for Quality Management Systems as requested by the manager.
• Support Internal Audit and Corporate Audit systems as requested by the manager.

Mandatory Requirements

• 3 years of experience with BS degree in the biological sciences or related field.
• Working knowledge of electronic Quality Management Systems.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards.
• Familiarity with electronic systems for Batch Record, Quality Management Systems, Veeva and Smartsheet.

Terms & Start

• 6 month contract to hire
• Onsite in Oceanside, CA
• Full time – 40hrs/week; benefits included (health, dental, vision, 401k)
• Vaccination required