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QA Associate II

Company: Minaris Regenerative Medicine
Location: Mountain View
Posted on: May 12, 2022

Job Description:

Quality Assurance Associate II At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Quality Assurance Associate II is responsible for performing Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs. Essential Functions And Responsibilities Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing. Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.) Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing. Release raw material in ERP system as well as on paper. Perform Accessioning of incoming Apheresis. Review Batch record and disposition material of finished product to client. Provides information for Out of Specification and deviations to investigator. Performs line clearance prior to manufacturing operations begins. Supports tech transfer activities. Other duties as assigned. Qualifications BS or higher education degree in a scientifically related field Experience in a biologics or biotechnology company (1 -3 years) Working knowledge and technical understanding of the aseptic manufacture of biologics preferred Working knowledge of GMP and TCTP regulations Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc) Competencies/Candidate Profile Relevant computer skills (Microsoft Office, Outlook) Detail-oriented and organized Analytical and problem-solving skills Good written and oral communication skills Ability to multi-task, prioritize, time manage and be adaptable Flexible and able to adapt to company growth and evolving responsibilities Ability to work independently and with a team Minimum Required Training To Be Completed within the first 90 Days of hire GXP training SOP & WI training Safety Training Supervisory Responsibilities This job has no supervisory responsibilities. Working Environment Must have the ability to work in a team-oriented environment and with clients Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen Must have the ability to work with specialized equipment Must be able to handle the standard/moderate noise of the manufacturing facility Physical Requirements Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance) Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Monday-Friday, 1st Shift (8:30AM-5:30PM), occasional weekend and holidays as needed.

Keywords: Minaris Regenerative Medicine, Mountain View , QA Associate II, Other , Mountain View, California

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