• 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.