GMP Sr. Specialist, Quality Assurance
Peregrine Pharmaceuticals, Inc.
 Garden Grove, CA

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 a Science degree and are trained in Good Manufacturing Practices (“GMP“)? If so, apply today!

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

Essential Duties and Responsibilities:

  • 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 4 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.

Qualifications:

  • B.S. degree in a Science discipline.
  • Require a minimum 4-6 years of experience in Manufacturing Batch Production Records review.
  • Must be able to interpret Quality standards for implementation.
  • Must have flexibility in problem solving and work hours to meet business objectives.
  • Require the ability to communicate clearly and professionally both in writing and verbally.
  • Skills to independently evaluate situations and propose potential solutions are essential.
  • Knowledge of cGMPs or equivalent regulations is preferred.
  • Industry experience working for a Contract Development and Manufacturing Organization (CDMO) is highly desirable.

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.