Job Description
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 Home - CSBIO (csbiomfg.com).
The Quality Assurance (QA) Specialist conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment; and with a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance. Contributes to the planning, implementation, and administration of cost effective Quality Programs, assuring that a system is in place which will meet contractual quality requirements. The QA Specialist will ensure the quality assurance of clinical manufacturing for quality standards of final cell products and identifies and assesses quality risk in activities and processes per regulatory guidelines, cGMPs, and standard operating procedures. Responsible for ensuring compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the cGMP facilities of the CBC. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing that appropriate standards of quality are attained and to assure that products are required quality for their intended use.
Primary Duties and 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, summarized 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 approve any changes to cGMP-systems to assure validated state of the systems is maintained.
- Creates and or maintain standardized templates for documents, forms, and similar to provide consistent finished product.
- Point of contact for Processing Change Orders (CO).
Qualifications
Education:
- Bachelor's Degree in molecular biology, biochemistry or 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.
Our compensation philosophy
We offer competitive total compensation that includes pay, benefits, and other recognition programs for our employees. The base pay range shown above takes into account the wide range of factors that are considered in making compensation decisions including knowledge/skills; relevant experience and training; education/certifications/licensure; and other business and organizational factors. This base pay range does not include our comprehensive benefits package and any incentive payments that may be applicable to this role. Pay Transparency Non Discrimination Provision (PDF) (opens in new window)
Diversity and Inclusion at Cedars-Sinai
We are caretakers and innovators committed to the pursuit of equitable healthcare. But health equity is not possible without representation. Our commitment to diversity goes beyond demographics or checking boxes. Our people must reflect the diverse identities, experiences and geographies of the communities and patients we serve – because that’s what our patients, colleagues and communities deserve. Quality Care and Research—For All, By All (opens in new window).
Cedars-Sinai is an Equal Employment Opportunity employer.
Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy. Cedars-Sinai’s AA Policy Statement (PDF) (opens in new window)