Quality Assurance

  • location: Marietta, PA
  • type: Contract
  • salary: $23.77 - $27.96 per hour

job description

Quality Assurance

Job Title: QA Specialist - Level 1 US

Job Summary

  • The QA Operations contingent provides a link between operations and the various quality systems. Primary responsibility is to directly support Formulation, Filling and Lyophilization (FFL) Operations through real-time, on-line batch record QA review and approval.
Job Responsibilities

  • Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
  • Provide advice and counsel on cGMP and related quality assurance issues to the value stream
  • Demonstrate sound decision making relating to quality issues
  • Provide on the floor QA support and perform QA Operations activities (batch record issuance and review, room release, event assessment, documentation review, etc)
  • Take initiative to follow-up on any issues concerned with quality documentation (e.g., investigations, deviations, and other required documentation).
  • Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
  • Alert management of production trends which may serve as forewarning of process or equipment problems.
  • Aseptic gowning experience preferred; gowning and presence in aseptic areas required.
Education & Qualifications

Required Qualifications:

  • BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
Preferred Qualifications

  • QA and/or GMP experience.
  • Working knowledge of pharmaceutical facilities, equipment and systems preferred. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
  • Experience working in Aseptic processing environment/Knowledge of Aseptic behaviors preferred.
  • Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Working knowledge of validation principles, quality systems (Deviations, CAPAs, Change controls) and FDA regulations.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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