29 days old

Quality Assurance Manager, Cell and Gene Therapy

Kelly Services
Davis, CA 95618
**Quality Assurance Manager**

**Duration: Temp-To-Hire**

**Benefits: Standard Kelly Benefits**

**Job Description:**

+ Lead Responsible for but not limited to: Approval or rejection of materials and reagents, intermediates, bulk and finished products in accordance to specifications.

+ Evaluation of batch records as part of the release process that meets specifications.

+ Evaluation of deviation reports relating to manufacturing, premises, equipment and documentation.

+ Ensures release testing has been performed and appropriate documentation is generated and stored with the batch records.

+ Conducts regular internal audits and self-inspections.

+ Implementation and development of electronic QMS in cooperation with GMP director Develops checks and maintains quality department, premises and equipment.

+ Ensures initial and continuous training of QC personnel.

+ Development and implementation of the GMP quality manual.

+ Develops and implements clinical supply chain procedures in cooperation with Management.

+ Coordinates and oversees operational compliance monitoring activities, including providing subject matter expertise to address/resolve quality and compliance related questions.

+ Lead Continuous Improvement projects

+ Assist in completing investigations, deviations, Out-of-specification reports, etc.

+ Assist in developing robust CAPAs to minimize reoccurrence of non-conformances and to prevent potential systemic compliance issues.

+ Quality Representative in Functional Area Team Meetings, serving as the go-to person answering quality related questions.

+ Author, review and/or approve related documents and records, such as for example, SOPs, Work Instructions, IQ/OQ/PQ, Analytical Test Methods, Specifications, etc

+ Assists and facilitate information in support of regulatory facility audits and inspections as needed. Implement the Change Management process by authoring and managing change controls.

+ Review and approve Validation Plans and Scientific Investigation Reports SIRs , including raw data review of lab test results.

+ Create and deliver training modules of quality topics.

+ Facilitate training related activities from a quality standpoint.

+ Should be highly knowledgeable in cGMPs, GLPs, GDPs e.g., FACT and FDA


**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-08-27 Expires: 2021-10-04

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Quality Assurance Manager, Cell and Gene Therapy

Kelly Services
Davis, CA 95618

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