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Posted August 23, 2026

Quality Assurance Specialist III

BioPhase Solutions
Orange County, CA, US Full Time

Job Description

Job Description
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Quality Assurance Specialist III to work for a leading Greater Orange County area contract manufacturing company.

Pay Rate: $35-40/hour
Duration: 6+ months - possibility of conversion down the line, but not guaranteed

Responsibilities:
  • QC testing pH, water content, assay titration, Loss on drying. UV. FTIR, HPLC, GC., mineral and microbiology The candidate also familiar with USP. EP. JP compendial testing.
  • US FDA 21CFR210, 211, 11 and applicable ICH guidance documents. Develop and revise QA procedures to strengthen cGMP compliance.
  • Reviewing 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.
Experience/Requirements:
  • Bachelor's degree with 3-5+ years in Lab & QA, or a minimum of 4+ years with both lab & QA related work experience.
  • Advance experience and knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to contract laboratory and/or aseptic manufacturing operations.
  • Advance experience and knowledge of USP, Pharm. Eur. (EudraLex) and other applicable standards.
  • Advance knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.
  • Advance experience and knowledge in the use of LIMS and electronic documentation systems.
  • 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.
  • Works on complex issues; exercises good judgement in selecting methods, techniques and evaluation criteria for obtaining results while handling Quality Assurance tasks.
  • Ability to perform routine work with minimal instructions, determines methods and procedures on new assignments.
  • May coordinate activities of other personnel.
  • Ability to work effectively under pressure in a rapidly changing environment.
  • Ability to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.
  • Ability to seek critical information from key resources to assist in problem solving.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).
Please send resumes to [email protected] and visit our website at www.biophaseinc.com for additional job opportunities!!!

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