Specialist, Quality Control

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.

Check out our website at https://avidbio.com!

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:

The Quality Control Specialist's main responsibilities will be in the area of QC Stability coordination. As part of the QC Stability team, the QC Specialist will review protocols, coordinate full sample lifecycle and compile testing summary packages.

Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Coordinate and maintain QC Stability sample lifecycle:
  • Prepare - STW/LIMS/label generation
  • Aliquot - sterile aliquoting of samples into assay specific individually labeled tubes
  • Ship/Track - track samples weekly to maintain on-time target delivery
  • Compile - review and compile data for Stability Summary of Testing reports
  • Dispose - coordinate sample inventory and disposition
• Perform aseptic sampling/aliquoting and gowning in clean room areas
• Receive / Log in samples to department sample Assignment Log and/or LIMS
• Store and maintain samples for easy identification of sample location within cold storage units
• Review of testing documentation from the QCA, QCM departments and 3rd party vendors
• Maintain the quality compliance of all QC operational areas
• Ensure and apply GMP throughout operations

Document Preparation:

• Maintenance and tracking of all QC Testing associated documentation (STWs and QC test method forms)
• Assist management in preparation of Stability Summary of Testing reports, Certificates of Authenticity and Statements of Testing as requested
• Generate weekly stability status reports for management using Excel
• Support internal and external audits
• Perform other duties as requested by management to support Quality activities

Position Type/Expected Hours of Work:

This role is a full-time, non-exempt position. Flexible schedule due to operations/scheduling.

• Work overtime and weekends as necessary
• Shift work: Monday - Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.

Qualifications:

• B.A. or B.S. degree in any related Science field - Biology, Chemistry, Biochemistry, etc.
• Minimum of 2 - 4 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Knowledge of cGMPs or equivalent regulations
• Ability to interpret Quality standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Skillful in problem solving and analytical thinking
• Flexibility in work hours to meet business objectives

Additional Qualifications:

Computer Skills - To perform this job successfully, an individual should have proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. Microsoft Office experience required (Excel, Word, PowerPoint).