GMP Change Control SME – Life Sciences QA & Compliance

SmartRecruiters, Inc.; West Point (PA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life and Disability Insurance

401(k) with company match

Paid vacation & holidays

Job summary

Eurofins Scientific in the United States is seeking a Senior GMP Change Control Lead to own and execute change control activities across lab operations. You will coordinate cross-functional teams, review complex change records, and ensure compliance with SOPs and regulatory requirements.

The role requires a Bachelor’s in Life Sciences and 5+ years in pharmaceutical or GMP environments; strong writing and leadership skills; on-site work in West Point, PA with full-time benefits.

Qualifications

• Bachelor\'s degree in Life Sciences, Biology, Chemistry, Microbiology, or related field.
• Minimum 5 years of GMP experience in pharmaceutical, biologics, or lab operations.
• Extensive GMP laboratory experience and regulatory compliance exposure.
• Proven expertise in change control, investigations, and quality systems.
• Strong analytical, writing and stakeholder communication abilities.

Responsibilities

• Execute GMP change control processes for laboratory testing.
• Own analytical change activities across multiple change control requests with cross-functional coordination.
• Ensure changes comply with SOPs, regulations, and specifications.
• Provide scientific and technical leadership for change initiatives.
• Lead root cause investigations and resolution of quality issues.
• Interpret regulatory expectations and maintain inspection readiness.
• Mentor and provide technical consultation to lab and QA personnel.

Skills

Leadership

Change control

GMP

Regulatory compliance

Analytical

Problem-solving

Written communication

Education

Bachelor\'s degree in Life Sciences or related

Tools

GMP systems

Change control software

Job description

Eurofins Scientific in the United States is seeking a Senior GMP Change Control Lead to own and execute change control activities across lab operations. You will coordinate cross-functional teams, review complex change records, and ensure compliance with SOPs and regulatory requirements.

The role requires a Bachelor’s in Life Sciences and 5+ years in pharmaceutical or GMP environments; strong writing and leadership skills; on-site work in West Point, PA with full-time benefits.