Quality Assurance Coordinator
Location: Parkwood, CA
Pay: $60-80k Ideal Salary Range (Direct Hire) + Benefits
We are seeking a highly motivated individual to join us as QA Operations Specialist at our commercial manufacturing site. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas.
Responsibilities include (but are not limited to):
• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
• Coordinate and facilitate Quality Assurance related production and production related activities, including:
-Issuance of electronic batch records and manufacturing labels.
-Assessment and closure of discrepancies, deviations and change controls requests.
-Communicate lot disposition pending issues to management.
-Review of batch manufacturing and testing documentation for timely delivery of final product.
• Ensure that tests are performed and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
• Support development of SOPs and review/approve SOPs to ensure quality objectives are met
• Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
• Review and approve manufacturing production records.
• Compile and verify all batch related documents into a final product lot disposition package.
• Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
-Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
-Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
-Provide periodic updates to management for deviations, system issues, non-conforming materials and products and CAPA.
• Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
• Manage and participate in internal, external and regulatory inspections and audits at the site.
• Perform other duties as required.
• Bachelor's degree with 5+ years of experience in Quality Assurance manufacturing facility.
• Shift Details: This position will support regular hours (M-F) in 2020
• Must be proficient in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management/CAPA.
• Working knowledge of quality systems and ability to apply GMP's in conformance to U.S. and EU standards.
• Experience with approving test method qualification/validation protocols and reports.
• Strong knowledge of GMP, SOPs and quality systems.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Strong interpersonal, verbal and written communication skills.
• Experience with change control practices and strategies.
• Proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work independently with personnel.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
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