Avid Bioservices
  • 10-Aug-2018 to 31-Oct-2018 (PST)
  • Quality Assurance
  • CA, USA
  • Full Time

Medical, Dental, Vision, 401 K with Company Match, 8 Designated Holidays, 4 Floating Holidays, 15 Days PTO, Wellness Program, Monthly Employee Appreciation Breakfast, ESPP


Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, 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!

Open for Associate, Specialist and Senior Specialist in QA dependent on experience.

(Currently No VISA Sponsorship nor Relocation Available/Local Candidates Preferred)

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

Essential Duties and Responsibilities:

  • Assist in the release of API batches and lots.
  • Release of Manufacturing Buffers and Formulations
  • Review of Manufacturing Batch Production Records - Must have at least 6 months to 1 year or more experience.
  • Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
  • Review of testing documentation from Microbiology and Chemistry groups.
  • Assist in compilation and client copying of Batch history records
  • Issue, verify and file documents relating to processes, equipment, facilities and utilities in the manufacture of product.

Qualifications:

  • B.S. degree in a Science discipline.
  • Require a minimum of 0 - 1 years (at Associate level) or 2 - 4 years (at Specialist level) or 5 - 6 years (at Senior level) of experience in the biopharmaceutical industry.
  • Industry experience working for a Contract Development and Manufacturing Organization (CDMO) is highly desirable.
  • Must have knowledge of cGMPs or equivalent regulations.
  • The ability to interpret Quality standards for implementation is required.
  • Skills to independently evaluate situations and propose potential solutions are essential.
  • Must be able to interpret Quality standards for implementation.
  • Require the ability to communicate clearly and professionally both in writing and verbally.
  • Must have flexibility in problem solving and work hours to meet business objectives.

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 the employee or applicant is a protected veteran.

Avid Bioservices
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