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QA Specialist - II

San Mateo, CA 94404

Posted: 11/21/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 514612 Country: United States Is job remote?: No

Job Description

Description:
Pay Rate Range: $40-47.90/hr
We are seeking a highly motivated individual to join us as QA Operations Specialist II at our commercial manufacturing site in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Must be proficient in Quality Systems, particularly associated with Operations and Management / CAPA.

This position will work 4 - 10 hour days, Wednesday to Saturday, 0700 - 1730.

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:
  • Assessment and closure of discrepancies, deviations and change controls requests.
  • On-the-floor support Quality support to manufacturing and QC staff.
  • Assessment and closure of laboratory investigations.
  • Timely assessment and closure of batch and material hold events.
  • 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 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.
  • 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, GMP and system issues, non-conforming materials and products, and CAPA.
  • Perform other duties as required.

Skills/Qualifications:
  • Bachelors degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 3-5 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
  • Must be proficient in Quality Systems, particularly associated with Operations and Exception Management/CAPA.
  • 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 laboratory investigations, deviations, and CAPA.
  • Experience with change control practices and strategies.
  • General knowledge of aseptic manufacturing processes.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Ability to communicate and work independently with scientific/technical 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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