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- Los Angeles, CA
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QA Operations Specialist
Apex Systems • Los Angeles, CA
Posted 3 days ago
An industry leader in Pharma/Biotech is seeking a QA Operations Specialist to join their team in west Los Angeles. This is a great opportunity to work for an industry leader! We look forward to reviewing your resume soon!
DUTIES AND RESPONSIBILITIES:
- Work with the Clinical Manufacturing, Materials Management and Quality Control departments as a Quality Assurance representative.
- Facilitate Quality Assurance related production and production related activities.
- Ensure timely issuance of production records, procedures and labels.
- Ensure timely assessment and closure of discrepancies, deviations and change controls requests.
- Ensure timely closure of laboratory investigations.
- Ensure timely assessment and closure of batch and material hold events.
- Communicate lot disposition pending issues to management.
- Ensure approval and timely delivery of final product.
- Ensure that tests are performed and products are manufactured in compliance with regulatory and GMP guidelines.
- Manage and perform area person in the plant activities.
- Review and approve manufacturing and validation documents for regulatory and compliance.
- Review and approve test reports.
- Review and approve manufacturing production records.
- Compile and verify all batch related documents into a final product lot disposition package.
- Support quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
- Provide Quality Assurance support in resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
- Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
- Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.
- Review and disposition raw materials and components for GMP use.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as required.
- Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 3 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Shift Details: Incumbents must be flexible to perform intermittent (and possibly regular) weekend work.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Some experience in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management/CAPA.
- Working knowledge of GMP, SOPs and quality systems.
- General knowledge of aseptic manufacturing processes.
- Working knowledge of change control practices/strategies.
- Knowledge of laboratory and/or production equipment.
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong written and verbal communication skills.
- Ability to communicate and work, under supervisor, with scientific/technical personnel.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178