Quality Assurance Specialist

Job Summary

• Primarily responsible for supporting the Client Research and Development quality agreement process with a focus on identifying and implementing process improvements.
• Lead or participate in technically complex and strategic cross-functional projects, demonstrating the ability to work across various teams.
• Drive or support strategic initiatives aimed at improving compliance with regulatory requirements and standards.
• Take a proactive role in process improvements, which includes the review and update of current supporting processes and procedures to enhance efficiency and effectiveness.
• Achieve a difficult balance of involvement, independence, and objectivity.
• Provide support for periodic review of Quality Agreements, ensuring alignment with organizational and regulatory expectations.
• Collect, analyze, and report relevant metrics to inform decision-making and track the effectiveness of initiatives.
• Consistently demonstrate Client's Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.

• Bachelor's degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
• Must have experience with quality agreements and knowledge of worldwide regulatory requirements that influence their content.
• Persuasive, effective communication skills are essential with an ability to work effectively across functions, across technical areas, and outside of the company.
• Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience

• 5-7 years of experience in Quality Assurance / Regulatory Affairs (Pharmaceutical or Medical Device preferred).
• 3-5 years of experience in clinical research and development or manufacturing, or analysis of investigational products.
• Minimum of 7 years' total combined experience required (Not necessarily the sum of the above).