QA Training Specialist

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 b.copeland@proclinical.com.

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.

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