Quality Assurance Associate - Gmp Biomanufacturing Center

With your help, we can change the future of healthcare!

The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease.

To learn more about the CBC, please visit: GMP Biomanufacturing Services | Cedars-Sinai.

Are you ready to be a part of groundbreaking research?

The Quality Assurance Associate will work closely with supervisor to support with implementation of inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance. Ensures products and processes are compliant with internal and external regulations and quality standards. Performs assessments and ensure adherence to SOPs, cGMPS, policies and procedures. Performs evaluation of internal controls, communications, risk assessment and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy and initiate corrective actions. May perform audits and risk assessments. Maintains and support the quality systems infrastructure.

Primary Duties and Responsibilities:

• Assist in the first-level enforcement of quality processes in compliance with quality procedures.
• Participates in training programs to facilitate the proper use and implementation of quality systems.
• Assists review of manufacturing processes and cGMP documents following procedures and policies.
• Collects and reviews defect data contained in non-conformance forms, summarized defect data and publishes trend charts and corrective action status and effectiveness.
• Assists with coordination and review of proficiency testing.
• Assists in performing root cause analysis and establishing corrective and preventative actions.
• Assists with document control and records management.
• Initiates corrective action in accordance with procedures.

Education:

• High School Diploma/GED is required. Associate Degree with cell research experience or Bachelor Degree in biology, biochemistry or related science/engineering field is preferred.

Experience and Skills:

• No experience is required. Three (3) years of experience in Quality or Regulatory compliance is preferred.

Working Title: Quality Assurance Associate - GMP Biomanufacturing Center
Department: CS Biomanufacturing Facility
Business Entity: Cedars-Sinai Medical Center
Job Category: Compliance/Quality
Job Specialty: Quality Measurement & Reporting
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$24.82 - $37.23