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
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.
The Quality Control Supervisor provides leadership and oversees
the day to day operations of the Quality Control HPLC Finished
Product and Stability Testing group. He or she will supervise the
performance and development of direct reports to ensure
organization and department goals are met. Must have strong
technical skills and GMP experience. The Quality Control HPLC
Supervisor will lead and support continuous improvement
Essential Functions: (Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
- Review analytical data, stability testing, draft and review of
technical reports, SOPs or Test Methods (related to lab operations,
method validation or creation, instrument qualification, procedure
verification and validation).
- Monitor progress of individuals and teams of QC analysts toward
- Plan and create QC schedules to accommodate manufacturing
support and client support.
- Supervise analysts in their work assignments and identify needs
for further training.
- Ensure adherence to regulatory compliance and cGMPs.
- Provide review and feedback including evaluations, and ensure
correct billing of time and materials to clients.
- Facilitate or coordinate training for QC personnel in areas of
regulations and compliance.
- Ensure thorough and proper documentation of activities in
respective log books and complete reviews.
- Perform instrument troubleshooting and train QC personnel in
existing methods and instruments.
- Responsible for thorough knowledge of cGMP and regulatory
requirements and ensure compliance.
Directs activities of functional areas through direct reports
Position Type/Expected Hours of Work:
This role is a full-time, exempt position. Days and hours of
work are Monday through Friday, 8:00 a.m. to 5 p.m. unless
otherwise stated by Manager. Must be available to work holidays,
weekends, or extended hours to support QC schedule.
- B.S. degree in Chemistry or Biology.
- Minimum of 5 years of life science industry experience in a QC
or analytical lab including 1 year of supervisory experience.
- Experience with the following: analytical testing and
equipment, writing reports/procedures/specifications,
chromatography, aseptic techniques, assay validations, GMPs and
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 protected veteran status.