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GMP Specialist, Quality Assurance (Lot Disposition) (Flex Team)

Company: Avid Bioservices
Location: Tustin
Posted on: May 3, 2021

Job Description:

Avid 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!

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:

The Quality Assurance Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Coordinate the release of API batches and lots.
  • Release of Manufacturing Buffers and Formulations.
  • Assist with discrepancy investigations.
  • Review of Manufacturing Batch Production Records - Must have at least 2 years or more experience.
  • Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
  • Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
  • Serve as a technical subject matter expert (SME) in support of department functions.
  • Review of testing documentation from Microbiology and Chemistry groups.
  • Compilation and QA Review of all records in Batch history records.
  • Issue, verify and file documents relating to processes, equipment, facilities and utilities in the manufacture of product.

Position Type/Expected Hours of Work:

This role is a full-time position. Flexible schedule due to operations/scheduling.

  • Work overtime and weekends as necessary
  • Shift work: Monday - Friday
    • 3pm - 12am

Qualifications:

  • B.A. or B.S. degree (preferably in Life Science).
  • Minimum of 2 - 4 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.
  • Knowledge of cGMPs or equivalent regulations.
  • Ability to interpret Quality standards for implementation and review.
  • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
  • Ability to communicate clearly and professionally both in writing and verbally
  • Skillful in problem solving and analytical thinking.
  • Flexibility in work hours to meet business objectives
  • Audit skill and/or certification is preferred.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid 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 Specialist, Quality Assurance (Lot Disposition) (Flex Team), Other , Tustin, California

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