Change Control Specialist

Eurofins; West Point (PA); Presencial; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Descripción de la vacante

Eurofins Scientific seeks a senior GMP Change Control Lead to drive complex change initiatives across multiple departments. You will own change activities, supervise SPR reviews, and ensure adherence to SOPs and regulatory requirements.

The role demands strong analytical skills, technical writing, and leadership in a GMP environment, with US work authorization. West Point, PA area offers full-time employment with comprehensive benefits.

Formación

• Bachelor’s degree or higher in Life Sciences or related field.
• 5+ years of GMP-related pharma/biologics laboratory operations or quality systems.
• Extensive GMP laboratory, quality systems, or pharma industry experience.
• Proven expertise in change control, investigations, quality systems, and regulatory compliance.
• Experience leading complex initiatives across multiple departments.
• 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 sponsorship.

Responsabilidades

• Execute GMP change control processes for laboratory testing.
• Own analytical change activities across multiple change control requests with SPR as SME.
• Ensure changes comply with specifications, SOPs, and regulations.
• Provide scientific and technical leadership for complex change initiatives.
• Evaluate regulatory, compliance, operational, and technical impacts of changes.
• Lead cross-functional teams through planning, implementation, and verification.
• Develop and implement strategic improvements to change management processes.
• Review and approve complex change records and supporting docs.
• Lead root cause investigations for quality and compliance issues.
• Interpret regulatory expectations and develop solutions for inspection readiness.
• Author and review technical reports, procedures, and regulatory support docs.
• Provide mentoring and technical consultation to lab and QA staff.

Conocimientos

Analytical skills

Problem solving

Leadership

Technical writing

Stakeholder communication

Regulatory compliance

Change control

Educación

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

Descripción del empleo

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.

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.