Senior GMP Change Control Lead

Vochure; Pennsylvania; Presencial; USD 100.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Descripción de la vacante

Eurofins USA PSS Insourcing Solutions is seeking an experienced Change Control Lead to drive GMP change control initiatives across multiple laboratories in the West Point, PA area. You will own change records, coordinate cross-functional teams, and ensure alignment with SOPs and regulatory requirements.

The ideal candidate holds a Life Sciences degree, 5+ years in GMP environments, strong analytical and technical writing skills, and the ability to mentor staff.

Formación

• Experience leading GMP change control projects across multiple departments.
• Strong analytical and problem-solving skills.
• Excellent technical writing and stakeholder communication abilities.
• Ability to mentor and provide technical consultation.
• Authorization to work in the United States without sponsorship.

Responsabilidades

• Execute GMP change control processes for laboratory testing.
• Own analytical change activities and ensure milestones.
• Ensure changes comply with SOPs and regulations.
• Provide scientific and technical leadership for change initiatives.
• Lead cross-functional teams through planning and implementation.
• Review complex change records and documentation.
• Investigate root causes of quality and compliance issues.
• Interpret regulatory expectations and maintain inspection readiness.
• Author and review technical reports and regulatory support docs.
• Mentor laboratory and quality personnel.

Conocimientos

GMP experience

Change control

Investigations

Quality systems

Regulatory compliance

Leadership

Technical writing

Stakeholder communication

US work authorization

Educación

Bachelor’s degree in Life Sciences, Biology, Chemistry, Microbiology, or related scientific discipline

Descripción del empleo

Eurofins USA PSS Insourcing Solutions is seeking an experienced Change Control Lead to drive GMP change control initiatives across multiple laboratories in the West Point, PA area. You will own change records, coordinate cross-functional teams, and ensure alignment with SOPs and regulatory requirements.

The ideal candidate holds a Life Sciences degree, 5+ years in GMP environments, strong analytical and technical writing skills, and the ability to mentor staff.