- Performing timely review of batch records, test results and supporting technical documentation. Work closely with QA management to proactively address the quality of documentation.
- Collaborating effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications, and other quality, documentation.
- Providing assistance during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies. This includes coordinating the retrieval of quality documents/records/trend data and any other documentation requested during these inspections.
- Providing support for execution of the supplier assurance program at the site
- Supporting review and release of raw materials and final product.
- Providing cGMP compliance guidance and advice as needed.
- Reviewing and approve deviations.
- Supporting QA management in gathering data necessary for tracking quality metrics.
- 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.
- Preferred 2 – 3 years industry related work experience.
- Bachelor's degree or equivalent in scientific discipline required.
- Proficient experience and knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to contract laboratory and/or aseptic manufacturing operations.
- Proficient experience and knowledge of USP, Pharm. Eur. (EudraLex) and other applicable standards.
- Proficient knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.
- Proficient experience and knowledge in the use of LIMS and electronic documentation systems (i.e. MasterControl).
- Works on problems of diverse scope; exercises good judgement in selecting methods and techniques for obtaining solutions while handling Quality Assurance tasks.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).
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QA Specialist - Orange County, United States - BioPhase Solutions
Description
Job Description
Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QA Specialist to work for an Orange County area contract manufacturing company.Pay Rate: $25-35/hour depending on experience.
Summary: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. Develop and revise QA procedures to strengthen cGMP compliance.
Responsibilities:
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