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. Do you
possess the skills and expertise below to improve patient lives and
support patient innovative therapies? If so, apply
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.
The Quality Assurance Specialist is an individual contributor who
solves a variety of issues following cGMP regulations and company
Essential Functions: (Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions.)
Coordinate the release of API batches and lots.
Release of Manufacturing Buffers and Formulations.
Assist with discrepancy investigations.
Review of Manufacturing Batch Production Records -
Must have at least 2 years
or more experience.
Sign documents for activities as authorized and described by
company policies, procedures and job descriptions.
Collaborate with departments to ensure that all review activities
are executed efficiently per governing SOPs.
Serve as a technical subject matter expert (SME) in support of
Review of testing documentation from Microbiology and Chemistry
Compilation and QA Review of all records in Batch history
Issue, verify and file documents
relating to processes, equipment, facilities and utilities in the
manufacture of product.
Type/Expected Hours of Work:
This role is a
full-time position. Flexible schedule due to
- Work overtime and
weekends as necessary
- Shift work: Monday
- B.A. or B.S. degree
(preferably in Life Science).
- Minimum of 2 - 4
years of experience in the pharmaceutical, biopharmaceutical or
related industry, or an equivalent combination of education and
- Knowledge of cGMPs
or equivalent regulations.
- Ability to
interpret Quality standards for implementation and
- Ability to make
sound decisions about scheduling, allocation of resources, and
- Ability to
communicate clearly and professionally both in writing and
- Skillful in problem
solving and analytical thinking.
- Flexibility in work
hours to meet business objectives
- Audit skill and/or certification is
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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