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Sr QA Associate in Thousand Oaks, CA at Apex Life Sciences

Date Posted: 12/3/2018

Job Snapshot

Job Description


Responsibilities:

  • Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.
  • Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of class 1 nonconformances and CAPAs.
  • Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
  • The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment. 

Basic Qualifications: 

  • Master's Degree OR Bachelor's Degree and 2 years of Quality experience OR Associate's degree and 6 years of Quality experience OR High school diploma/GED and 8 years of Quality experience 


Preferred Qualifications: 

  • Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field. 
  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices. 
  • Experience managing projects through to completion meeting timelines 
  • Evaluating documentation and operations according to company procedures 
  • Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk 
  • Experience working with Quality Systems 
  • Strong organizational skills and ability to manage multiple tasks at one time 
  • Effective communication skills (both written and verbal) 
  • Demonstrated ability to work as both a team player and independently 

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.




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