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Quality Assurance Associate

Location:
Poway, CA

Description:
The Quality Assurance Associate is responsible for working closely with the Quality Assurance Manager to assist in the development and maintenance of Quality Management Systems at VetStem. These systems will ensure the safety, efficacy, and purity of the products manufactured by VetStem. The VetStem manufacturing facility is a state-of-the-art, GMP and GTP compliant controlled cleanroom facility designed to enable production of regenerative medicine products.

Primary Responsibilities
Develop and maintain the following systems:
Document control
Records management
Raw material control
Change control
Labeling
Validation activities
Specification development
Corrective action and process improvement
Record keeping associated with tissue screening/ donor eligibility
Support QA with the day-to-day management of the following
Manage day-to-day document control, maintaining files in an organized manner
Assure that training files are complete and organized
Issue labels
Review completed records prior to filing in Records Management
Assist in records management
Maintain files of technical reports and change control files
Maintain Quality Assurance metrics
Assist in closing and filing manufacturing batch records
Assist in deviation investigations and coordination of corrective and preventive actions (CAPA)

Secondary Responsibilities:
Support FDA inspections, internal audits from 3rd parties, and external audits, including completion of customer supplier evaluations and review of supplier agreements
Support production activities as needed
Assist in training of staff on regulatory requirements and internal procedures as applicable
Perform additional job related duties as required

Requirements:
2+ years of experience in a Quality Assurance role; prior experience within a cGTP/cGMP regulated biotech, cell processing, tissue bank or pharmaceutical company preferred
Demonstrated ability to manage and prioritize multiple projects and meet deadlines
Excellent time management and organizational skills
Strong written and verbal communication skills
Understanding of the field of cell therapy processing and cryopreservation preferred
Exceptional analytical skills and solutions-oriented approach to problem-solving
Ability to work effectively in a fast-paced, rapidly changing environment
Demonstrated ability to work independently as well as part of an integrated team
Flexibility and dedication: Position may require some “off-standard hours”

To apply for this position reference job code QM-87222 in the Subject line and send resume with cover letter to VetStem Biopharma

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12860 Danielson Court, Suite B, Poway, CA 92064 Phone: 858-748-2004 or 888-387-8361