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GMP Engineer, Quality Assurance (Viral Vector)

Company: Avid Bioservices
Location: Tustin
Posted on: May 16, 2022

Job Description:

Job DescriptionAvid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including cell culture and feed optimization, analytical methods development, and product characterization.We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!Check out our website at https://avidbio.com!In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.Covid-19 Hiring Update: We are continuing to interview and hire during this time. Avid Bioservices' is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually.Summary/Objective:The Quality Assurance Engineer (Viral Vector) is an individual contributor who performs a variety of activities to ensure compliance with applicable quality and regulatory requirements. Primary responsibilities include reviewing and approving change controls for implementation of critical utilities, manufacturing equipment, analytical instruments, computerized systems, and software. Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Review and approve Engineering Change Requests pertaining to facility and equipment through reviewing and approving Commissioning and Qualification (C&Q) documents, Requirement Specifications (e.g., URS and DS), Standard Operation Procedures (SOPs), and other pertinent documents.
  • Attend change control review meetings as the Quality Representative for projects pertaining to facility and equipment implementation and/or changes.
  • Assist project team members in initiating change requests for facility, equipment, and documents.
  • Provide quality assessment and collaborate with project team members to resolve change control issues.
  • Review and approve controlled documents such as calibration, maintenance, certification, and revalidation relating to manufacturing equipment, computerized systems, analytical instruments, facilities, and critical utilities in the manufacture of product.
  • Interact with project team members on discrepancy assessment, resolution, and quality approval.
  • Participate in investigations to ensure discrepancies are thoroughly identified, defined, properly assessed, and approved.
  • Review and approve controlled documents relating to processes, equipment, facilities, and utilities in the manufacture of product.
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.Position Type/Expected Hours of Work:This role is a full-time, exempt position. Days of work are Monday through Friday unless otherwise stated by Supervisor or needed due to projects. Must be available to work holidays, weekends, or extended hours when needed. Required Education and Experience:
    • Bachelor of Science degree in a Life Science is required, such as Biology, Microbiology, Biochemistry, Chemistry
    • Minimum of 4 years of work experience in the pharmaceutical or biopharmaceutical industry. Knowledge of FDA cGMP regulations and quality compliance requirements is required.
    • Excellent professional communication skills both verbally and in writing.
    • Experience in validation or quality engineering is preferred.
    • Understanding of Biosafety Level practices is a plus.EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERAvid Bioservices, Inc. does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

      Job Posted by ApplicantPro

Keywords: Avid Bioservices, Tustin , GMP Engineer, Quality Assurance (Viral Vector), Engineering , Tustin, California

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