Change Control Specialist

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

West Point, PA, USA

Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• 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

• 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.

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.