Avid Bioservices
  • 17-Aug-2018 to 31-Oct-2018 (PST)
  • Quality Assurance - Quality Systems
  • 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!

Summary:

The Specialist, Quality Systems, is responsible for performing administrative tasks related to Avid's Quality Management Systems (including deviations and CAPAs) and training system.

Essential Duties and Responsibilities include the following. Other duties may be assigned:

  • Perform administrative tasks associated with Avid's electronic Quality Management System; this includes (as applicable) assigning, classifying, and updating records, and moving records on workflows.
  • Host regularly scheduled meetings to discuss QMS and CAPA records; work closely with departmental stakeholders and subject matter experts to ensure Quality records are closed on time.
  • Track quality system records; send reminders to authors and approvers.
  • Trend quality system records; prepare and report quality system metrics.
  • Perform administrative tasks associated with electronic training system; this includes (as applicable) creating and revising curricula, assigning curricula to personnel, and generating training reports.
  • File paper-based training and other records.
  • Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs).
  • Provide support during regulatory and other inspections; maintain a state of inspection readiness.
  • Perform other duties as assigned by Quality management.

Supervision Received:

General supervision: routine duties are performed with minimal supervision; standard practices or procedures allow incumbent to proceed alone at routine work; work is reviewed upon completion.

Position Type/Expected Hours of Work:

This role is a full-time, non-exempt position. General days and hours of work are Monday through Friday 8:00am to 5:00pm, unless otherwise stated by Supervisor. The incumbent may need to work overtime and/or weekends when necessary.

Education and/or Experience:

  • Minimum of a Bachelor's degree, preferably in Biochemistry, Biology, Chemistry, or other scientific field, and 2 - 4 years of experience in the pharmaceutical or biopharmaceutical industry, or equivalent combination of education and experience.
  • Familiarity with ICH and FDA guidelines, GMP regulations, and quality compliance requirements preferred.
  • Excellent writing skills and editing, formatting, and organization skills. 
  • Excellent attention to detail and customer service attitude. 
  • Flexibility in problem solving and work hours to meet business objectives.

 

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices 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.

Avid Bioservices
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