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Quality Associate (Biology New Graduates) in Irvine, CA at Apex Life Sciences

Date Posted: 12/6/2018

Job Snapshot

Job Description


Pharmaceutical/Medical Device Company in a strong growth phase is seeking a Quality Associate to support the Quality Management System and QA Product Release Group.

Please send resumes to


1. Support the implementation and maintenance of an efficient system for reviewing and releasing finished product.

2. Provide support for the QA Complaint system for all product lines. Duties include the receipt and Investigation of complaints, correspondence with internal/external customers and with RA/QC.

3. Perform and coordinate QA documentation system. Assist in the review and modification of different manufacturing procedures and documents as part of continuing process improvements.

4. Provide in-process support in the manufacturing of all saleable products.

5. Receive, sample and analyze appropriate samples for the release testing of raw materials and in-process materials. Perform the QA testing on all applicable FDA, USP, NF, CFR and other standards.

6. Maintain protocols and final report files, reserve samples, product complaints and batch records.

7. Perform validation testing to support the release of raw materials, in-process materials and finished product. Execute protocols to support the validation of new equipment and products.

8. Review all notebooks and summary reports for accuracy, completeness and compliance to relevant procedures and standards.

9. Communicate with laboratory personnel/manager to correct and improve deficiencies in data collection, analysis and reporting.

10. Investigate laboratory deviation or systemic problems to identify root cause and effective corrective and preventive actions.

Required Knowledge, Skills and Abilities

  • Working knowledge of QA/QC principles
  • Knowledge and training in GMP/GLP/ISO guidelines.
  • Good computer skills
  • Strong attention to detail
  • Good oral and written communication skills

Required Education and Experience

  • BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required
  • Up to 2 + years’ experience in Quality Assurance / Manufacturing environment 

EEO Employer

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.