Quality Assurance Specialist - GMP Biomanufacturing Facility

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 a cGMP cell‑manufacturing facility housing multiple clean‑room 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 Home – CSBIO.

About the role

The Quality Assurance (QA) Specialist conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment, and works with a team to implement inspection plans, quality plans, support auditing functions, and evaluate supplier performance. The specialist contributes to the planning, implementation, and administration of cost‑effective Quality Programs, ensuring systems meet contractual quality requirements, and guarantees compliance with all Federal and State laws, regulations, and accrediting‑agency requirements for biopharmaceutical products manufactured in the cGMP facilities of the CBC.

Responsibilities

• Assists in the second‑level QA subject‑matter‑expert/enforcement review of processes in compliance with quality procedures; overall objective of review for investigation.
• Measures and evaluates supplier quality and delivery performance; maintains supplier quality record files; maintains supplier approval status.
• Collects and reviews defect data contained in non‑conformance forms, summarizes defect data and publishes trend charts and corrective‑action status and effectiveness.
• Assists with document control and records management.
• Serves as a SME on the use of risk‑based tools for qualification, training, monitoring and disqualification.
• Assesses and approves any changes to cGMP systems to assure a validated state of the systems is maintained.
• Creates and/or maintains standardized templates for documents, forms, and similar items to provide a consistent finished product.
• Point of contact for Processing Change Orders (CO).

Qualifications

Bachelor’s Degree in molecular biology, biochemistry or a related science/engineering field is required.

Experience and Skills

• Three (3) years of experience in Quality or Regulatory compliance is required; five (5) years is preferred.
• Ability to apply critical thinking to analyze and interpret information and/or data.
• Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
• Ability to provide and/or support a level of work excellence and accuracy; recognize and address flaws or errors that others may overlook.
• Ability to apply advanced knowledge of science/learning/specialized intellectual instruction to analyze, interpret or make deductions from varying facts or circumstances.
• Ability to develop and deliver effective presentations.
• Ability to operate mechanical/medical devices and/or equipment.
• Ability to handle multiple demands and/or manage complex and competing priorities.
• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.