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Document Control/GMP Training Specialist, Quality Assurance

Company: Avid Bioservices
Location: Tustin
Posted on: May 6, 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.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.Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs).Perform administrative tasks associated with Avid's electronic Learning Management System.Review controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.Track quality system records; send reminders to authors and approvers.Review change requests and assist with discrepancy investigations.Provide Quality oversight to internal and external customers.Collaborate with departments to ensure that all review activities are executed efficiently and effectively.Provide support during regulatory and other inspections; maintain a state of inspection readiness.Qualifications: Bachelor's degree (preferably in Life Science) and 2 to 4 years of experience in the pharmaceutical, biopharmaceutical, medical device or related industry, or an equivalent combination of education and experienceExperience in cGMPs or equivalent regulations requiredExperience with document control process and ability to lift and/or move up to 50 poundsAbility to interpret Quality standards for implementationExcellent writing skills and editing, formatting, and organization skillsExcellent attention to detail and customer service attitudeAbility to independently evaluate situations and propose potential solutionsAbility to communicate clearly and professionally both in writing and verballyFlexibility in problem solving and work hours to meet business objectivesEQUAL 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 the employee or applicant is a protected veteran.

Keywords: Avid Bioservices, Tustin , Document Control/GMP Training Specialist, Quality Assurance, Other , Tustin, California

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