Quality Assurance Specialist III

Company: Jobot
Location: Irvine
Posted on: September 9, 2023

Job Description:

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 DetailsResponsibilities:

• 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 audits
• Providing subject matter expertise for the supplier assurance program at the site
• Providing QA management with the support needed for compliance training.
• Maintaining workspace cleanliness by adhering to the 5S method of organization.
• 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 experience.
  • Bachelor's degree or equivalent in scientific discipline required.
  • 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