Quality Assurance Specialist III
Posted on: September 9, 2023
Great Pharma company in Irvine - benefits are attractive, and a
commitment to work-life balanceThis Jobot Job is hosted by: Michael
MontevideoAre you a fit? Easy Apply now by clicking the "Apply"
button and sending us your resume.Salary: $80,000 - $90,000 per
hourA bit about us:We are your single source for high-quality
chemistry, manufacturing and control (CMC) services for the pharma,
biotech, and medical device industries. Our comprehensive suite of
services streamlines processes to accelerate time-to-market. With
more than 30 years' experience, we have deep scientific expertise
across a range of products, with a special focus on
oligonucleotides.Why join us?As a QA Specialist III, you'll review
GMP technical documentation to ensure quality standards are met and
compliant with applicable SOPs, US FDA 21CFR210, 211, 11 and
applicable ICH guidance documents. You will also develop and revise
QA procedures to strengthen cGMP compliance.Job
- Reviewing batch records, test results and supporting technical
documentation. Work directly with operations management to resolve
findings noted during the review process.
- Performing release of raw materials and consumables.
- Reviewing and approving Certificate of Analysis for raw
materials, drug substance and drug products.
- Collaborating effectively with operations management to review
and approve: SOPs, protocols, reports, equipment qualifications and
calibrations, change controls, specifications trend reports and
other quality documentation.
- Responsible for writing/revising Quality Assurance procedures
to strengthen compliance with cGMPs.
- Reviewing and approving deviations and gather/issue quality
metrics reports to QA management.
- Providing QA support during cGMP compliance inspections of the
facility by clients, the FDA and/or other regulatory bodies.
- Acting as a co-auditor during supplier/internal quality
- Providing subject matter expertise for the supplier assurance
program at the site
- Providing QA management with the support needed for compliance
- Maintaining workspace cleanliness by adhering to the 5S method
- Abiding by safe work practices and adhere to general safety
rules, performing all duties in a safe manner and never placing
yourself or those around you in an unsafe condition. Report all
unsafe conditions to your supervisor.
- This list of duties and responsibilities is not all inclusive
and may be expanded to include other duties and responsibilities,
as management may deem necessary.Required Skills/Abilities:
- A minimum of 3 - 5 years preferred, industry related work
- Bachelor's degree or equivalent in scientific discipline
- Advanced experience and knowledge of cGMP regulations, and FDA
and ICH guidelines as they pertain to contract laboratory and/or
aseptic manufacturing operations.
- Advanced experience and knowledge of USP, Pharm. Eur.
(EudraLex) and other applicable standards.
- Advanced knowledge of root cause investigation and problem
solving; experience in the use of 5 Whys and/or other appropriate
root cause investigation tools.
- Advanced experience and knowledge in the use of LIMS and
electronic documentation systems (i.e. MasterControl).
- Strong interpersonal skills. Must be able to express oral and
written communication in a clear and concise manner and effectively
present information and respond to questions from managers,
customers and employees
- Effective organizational and time management skills with the
ability to multi-task and prioritize assignments as needed.
- Ability to perform routine work with minimal instructions,
determines methods and procedures on new assignments.Interested in
hearing more? Easy Apply now by clicking the "Apply" button.
Keywords: Jobot, Irvine , Quality Assurance Specialist III, Other , Irvine, California
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