Misc. / Other

QA Associate

Direct Hire/Permanent

Accounting Career Consultants

QA Associate St. Louis, MO

Job Reference: JOB-20090

QA Associate Job Description Core Responsibilities

  • Support Quality Management System roll-out and maintenance at a site developing and conducting In-vitro diagnostic tests
  • Contribute to the creation, review, and approval of company policies, procedures, standards, and training requirements
  • Participate in various Quality Management System processes including, but not limited to document control, training, change control, design control, supplier quality, complaint management, deviation/CAPA management, and audit management.
  • Review and approval of qualification and validation standard operating procedures, protocols, reports, and general analytical data
  • Adhere to all company policies, procedures, standards, and training requirements
  • Adhere to cGMP as it applies to Quality System Regulation (QSR – 21 CFR Part 820) and maintain compliance as required

Desired Education

  • Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering, or Physics

Desired Experience

  • At least 2 years’ quality assurance experience in a regulated pharmaceutical, biopharmaceutical, or IVD/Medical Device industry
  • Quality auditing as a lead auditor (internal or external)
  • Firm understanding of 21 CFR 11 and 820
  • Experience implementing Quality Management System software and supporting documents
  • 1+ years’ experience with quality assurance validation activities
  • Familiarity with quality control principles and common analytical methods

Mark Kurz
Principal

I look forward to assisting you with your search and assessing whether this role could be a good fit for you. Please apply for confidential consideration!

Tel: 314-292-7908 | Email: mkurz@careeradvancers.com

Tagged as: QA Associate