- 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.