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:
As an individual contributor, performs a wide variety of activities to ensure compliance with applicable quality and regulatory requirements by conducting internal and external audits, data and documentation reviews and analysis. Prepares audit reports regarding compliance findings and concerns and provides recommendations for corrective actions. Coordinates resolution of quality issues with suppliers and monitors quality metrics. Writes and revises SOPs. This position focuses on regulatory compliance, strict adherence to the company's quality policy, in addition to improving and implementing cGMP practices.
OBJECTIVE:
ESSENTIAL DUTIES AND RESPONSIBILITIES include but are not limited to the following:
TECHNICAL DUTIES/RESPONSIBILITIES:
POSITION TYPE/EXPECTED HOURS OF WORK:
This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.
QUALIFICATIONS:
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.
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