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.

Qualifications :

• Bachelors 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.

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time