GMP Change Control Lead — Cross‑Functional Scientist

Eurofins US Network; West Point (PA); Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) with Match

Paid Vacation

Descripción de la vacante

Eurofins USA PSS Insourcing Solutions in West Point, PA is seeking a senior Change Control Lead to manage GMP-related change controls across laboratory operations. You will coordinate teams, review technical documentation, and drive root-cause investigations to ensure regulatory readiness.

The role requires a life sciences background, 5+ years in GMP environments, and strong technical writing and leadership abilities. Monday–Friday, on-site in West Point with comprehensive benefits.

Formación

• Bachelor’s degree in Life Sciences or related field.
• Minimum 5 years of GMP/biopharma lab/quality systems experience.
• Proven expertise in change control, investigations, and regulatory compliance.
• Strong leadership, communication, and problem-solving skills.

Responsabilidades

• Lead GMP change control activities and ensure milestones are met.
• Serve as SME for change control projects and coordinate cross-functional teams.
• Evaluate regulatory and quality impacts of proposed laboratory changes.
• Review complex change records and supporting documentation.
• Lead root cause investigations and drive effective resolutions.
• Mentor laboratory and quality personnel and ensure inspection readiness.

Conocimientos

GMP change control

Quality systems

Regulatory compliance

Cross-functional leadership

Technical writing

Root cause investigations

Mentoring

Educación

Bachelor’s degree in Life Sciences or related

Descripción del empleo

Eurofins USA PSS Insourcing Solutions in West Point, PA is seeking a senior Change Control Lead to manage GMP-related change controls across laboratory operations. You will coordinate teams, review technical documentation, and drive root-cause investigations to ensure regulatory readiness.

The role requires a life sciences background, 5+ years in GMP environments, and strong technical writing and leadership abilities. Monday–Friday, on-site in West Point with comprehensive benefits.