Apex Systems QA Associate II in St. Louis, Missouri

QA Associate II in St. Louis, MO at APEX Systems

Date Posted: 1/5/2019

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Job Snapshot

  • Employee Type:

Full-Time

  • Location:

St. Louis, MO

  • Job Type:

Other

  • Experience:

Not Specified

  • Date Posted:

1/5/2019

Job Description Job #: 914442

QA Associate 2

Summary:

This individual will assist functional departments with Quality needs and understanding of Quality procedures and Regulations.

Responsibilities:

Act as subject matter expert in one or more of the following validation focused areas: equipment, instruments, facilities, utilities, cleaning, sterilization, computer systems.

Oversight of quality aspects for documentation and processes related to these areas.

Review and approve documentation, including validation periodic reviews, plans, protocols, summary reports, and all other validation related documentation.

Advise functional departments on Quality procedures and Regulations to ensure compliant validation documentation.

Complete change management assessments for validated equipment, systems, and processes.

Requirements:

Education

Minimum of a Bachelor’s Degree in Engineering, Life Sciences or Computer Science.

Experience

2-5 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.

Knowledge, Skills, Abilities

Exposure and knowledge of industry standards and cGMP regulations.

Technical Writing Skills

Able to work in environmental clean rooms.

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