QA Training Specialist

QA Training Specialist

ProClinical | King Of Prussia, PA, 19406, US
Salary Range:$57,000 – $90,000 Salary range estimated by Zippia

Posted 13 days ago

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Proclinical is seeking a QA Training Specialist for an innovative gene-therapy organization located in King of Prussia, PA.

Job Responsibility:

  • Acts as part of GMP Quality Assurance (QA) and is the Quality Assurance Document/Training Specialist.
  • Processes and formats GMP controlled documents from initiation through the review & approval process using both paper and electronic documentation systems.
  • Maintains GMP training files using both paper and electronic training systems in accordance with established procedures.
  • Exercises routine level of independent decision-making and ability to train and mentor others.
  • Seeks out advice on complex quality decisions from Manager/ Director QA. Supports Veeva System Administrator to transition the documentation management from a paper to electronic process.
  • Performs project specific tasks and duties with minimal guidance.
  • Follows established procedures.
  • Interacts with external clients, consultants, vendors and contract research/manufacturing organizations, and Regulatory Agency officials during audits or inspections.

Skills and Requirements:

  • Bachelor's degree in life science and 2 to 3 years of experience or equivalent combination is required. Advanced degree preferred.
  • 5 year's experience in Quality Assurance position(s) is preferred.
  • Operative knowledge of MS Office (including SharePoint) computer skills.
  • Metrics/Monitoring (Data analysis, Trending & Reporting - also includes providing Quality Issue updates, and escalation items for Quality Meeting review).
  • Process improvements skills with respect to quality, including (but not limited to) change control, deviations, OOS's, CAPAs.
  • Experience in Electronic Training Platforms e.g., Knowledge Link.
  • Quality Culture Knowledge: Thorough knowledge and experience with GxP quality assurance initiatives/programs and regulatory requirements.
  • Effective communication skills (verbal and written).
  • Excellent interpersonal skills.
  • Highly organized and result-oriented.
  • Productive ability to meet short and long-term goals.
  • Proactively anticipates challenges and develops & implement successful solutions.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at (+1) 267-297-3280 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.