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Consultant, Quality Assurance Specialist III - Biotech

Company: GForce Life Sciences
Location: Santa Monica
Posted on: August 1, 2022

Job Description:

Consultant, Quality Assurance Specialist III - BiotechSummaryOur client, a Fortune 500 Biotech Company, leading the industry in the fight against cancer, has engaged GForce Life Sciences to provide them with a Quality Assurance Specialist III. This position will report to the Sr. Manager of Quality Assurance within the Quality RDMC department. The Quality Assurance Specialist III will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Client's quality practices. In addition, you will also provide objective evaluation of process performance and product quality and support the department for continual contributions towards site and Client's quality goals. This role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of the Client. Duties / Expectations of RoleWork closely with and provide quality assurance support across functions (Manufacturing, Supply Chain, Site QC, Process Development, Regulatory Affairs, Site QA, and QS) within Kite and externally to assure compliance and strong relationships.

  • Provide QA support on the floor up to 50% of the time. On-Site Full Time.
  • Batch documentation review and ensure resolution of issues to release product
  • Review and approval of Deviations and CAPAs Support Disposition of product for U.S. and other countries
  • Support of New Product Introductions
  • Support quality assessments of internal operations to analyze quality compliance and assess risk
  • Provide QA guidance on product development projects and technical transfer activities
  • Support Management Review activities and oversee trending of key quality, product and GMP metrics
  • Support regulatory inspections, internal audits, and external audits from partners
  • Review technical (process and analytical) reports as appropriate
  • Support the viral vector manufacturing site
  • Participates in developing Standard Operating Procedures to ensure Quality objectives are met
  • Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished product.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products Mandatory Requirements
    • Master's Degree and 3+ years' experience in a GMP environment OR
    • Bachelor's Degree and 5+ years' experience in a GMP environment OR
    • High School Degree and 9+ years' experience in a GMP environment
    • Cell Biology and/or Cell Therapy experience/foundation Term & Start
      • 6 Months Contract with the opportunity to convert to FTE after 6 months.
      • Start Date: As soon as possible
      • Full time (40 hours/week)
      • On-Site in Santa Monica, CA - (RDMC Group/Building)- Clinical Manufacturing Site
      • No Travel
      • W2 Benefits included (Medical, Dental, Vision)
      • Vaccine is required.
      • The Interview process consists of a Zoom Interview with the Hiring Manager and potentially a 2nd interview with other team members, and then a decision will be made.

Keywords: GForce Life Sciences, Santa Monica , Consultant, Quality Assurance Specialist III - Biotech, Professions , Santa Monica, California

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