Change Control Specialist

• Responsible for executing Good Manufacturing Practices (GMP) change control processes for various laboratory testing. • Have ownership of all analytical change activities of several change control requests, cross-functional proactive communication from start to finish, coordination to ensure key milestone completions, Second Person Review (SPR) as the change control Subject Matter Expert (SME) of the project • Ensure the change control process is in accordance to associated specifications, procedures, Standard Operating Procedures (SOPs), and regulations. • Provide scientific and technical leadership for complex change control initiatives. • Evaluate regulatory, compliance, operational, and technical impacts of proposed laboratory changes. • Leads cross-functional teams through change planning, implementation, execution, and effectiveness verification. • Develop and implement strategic improvements to change management processes. • Review and approve complex change records, technical assessments, and supporting documentation. • Lead root cause investigations and resolution of complex quality and compliance issues. • Interpret regulatory expectations and develops solutions to maintain inspection readiness. • Author and review technical reports, procedures, change strategies, and regulatory support documentation. • Provide mentoring and technical consultation to laboratory and quality personnel. • Bachelor’s degree in Life Sciences, Biology, Chemistry, Microbiology, or related scientific discipline. • Minimum 5 years of pharmaceutical, biologics, laboratory operations, quality systems, or related GMP experience. • Extensive GMP laboratory, quality systems, or pharmaceutical industry experience. • Proven expertise in change control, investigations, quality systems, and regulatory compliance. • Experience leading complex technical initiatives across multiple departments. • Demonstrated ability to evaluate and implement new technologies and methodologies. • Strong analytical, problem-solving, organizational, and leadership skills. • Excellent technical writing and stakeholder communication abilities. • Authorization to work in the United States indefinitely without restrictions or sponsorship. This position is Full-Time, Monday-Friday 8am-5pm. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply. • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options • Life and disability insurance • 401(k) with company match • Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.