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Senior QA Validation Associate in St. Louis, MO at Apex Life Sciences

Date Posted: 12/13/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Senior QA Associate II!

This is a non-supervisory role, reporting to the Manager of QA Validation, which is a sub-group within the Quality Assurance Department.  This role will serve as a subject matter expert to advise functional departments with Quality needs and understanding of Quality procedures and Regulations.  A Sr. QA Associate is a recognized subject matter expert in two or more of the following validation focused areas: equipment, instruments, facilities, utilities, cleaning, sterilization, computer systems, process, method.  This individual is responsible for overseeing quality aspects for documentation and processes related to these areas.  Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects. 

What will you do?             

  • Review and approve documentation, including validation periodic reviews, plans, protocols, summary reports, and all other validation related documentation.
  • Mentor and advise peers and functional departments on Quality procedures and Regulations to ensure compliant validation documentation.
  • Complete change management assessments for validated equipment, systems, and processes.

Requirements 

  • Bachelor’s Degree in Engineering, Life Sciences or Computer Science.
  • 8+ years of experience in Quality Assurance and/or Validation, or equivalent pharmaceutical industry experience.
  • Direct experience in two or more of the following areas: Process Validation; Method Validation; Validation of computerized systems, software, automation, analytical instruments, utilities, manufacturing equipment, cleaning, sterilization, or general equipment validation.
  • In depth knowledge of industry standards and cGMP regulations.
  • Demonstrated ability to work on multiple assignments effectively.
  • Excellent organizational skills and problem solving abilities.

Knowledge, Skills, Abilities

  • Technical Writing Skills
  • Able to aseptically gown and work in environmental clean rooms, as needed.
  • Able to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Able to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
  • Regularly required to talk and hear. The employee frequently is required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

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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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