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 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
Covid-19 Hiring Update:
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.
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.
Support the Director, Quality Assurance Compliance by conducting
internal audits of Avid Operations and Quality Systems and external
audits of Avid's vendors. Follow up on internal and external audit
results to ensure appropriate responses during
Develop solutions to complex issues and Quality initiatives
following cGMP regulations
Perform tasks and work to achieve company goals and organizational
Essential Duties and Responsibilities include but
are not limited to the following:
Follow company policies and procedures.
Establish work priorities to meet targets and
Perform independent internal and external audits for adherence to
cGMPs and other relevant Federal, foreign and corporate regulations
Follow up on audit response and corrective actions.
Review data, records and documents to assess appropriateness of
investigation, root cause identification and corrective action
Serve as the Quality Compliance representative on cross-functional
Identify, design, and implement process and system
Evaluate regulatory requirement changes, impact to company's
operations and make recommendations to management.
Support client audit and regulatory inspection (FDA and Foreign)
Serve as a technical subject matter expert (SME) in support of
Mentor junior personnel serving as a subject matter expert (SME) on
Quality systems, processes and issues.
Notify Management of potential quality or regulatory issues that
may affect product quality or regulatory compliance.
May conduct investigations related to non-compliance
Review and approve quality management
Participate in discrepancy investigations. Ensure discrepancies are
thoroughly identified, defined and properly assessed.
Participate in company audit readiness activities.
Interact with interdepartmental contacts on discrepancy assessment,
resolution, and quality approval.
Provide guidance to internal and external customers on best
practices for maintaining a quality program.
Ensure that the proper policies and procedures are in
Identify, design, and implement process improvements.
Provide input into the design and presentation of departmental
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.
B.A. or B.S. degree (preferably in Life Science) and at least 5-6
years of experience in the pharmaceutical, biopharmaceutical or
related industry, or an equivalent combination of education and
Sound knowledge of cGMPs or equivalent regulations
Ability to interpret and relate 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
Skillful in problem solving and analytical thinking.
Flexibility in work hours to meet business objectives
Audit skill and/or certification is preferred.
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.
Job Posted by ApplicantPro