Change Control Specialist

Eurofins PSS Insourcing Solutions; West Point (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions in West Point, PA is seeking a Change Control Lead to execute GMP change control processes for laboratory testing, owning multiple change events from start to finish. Responsibilities include reviewing records, coordinating SPR, and ensuring alignment with SOPs.

This role provides scientific and technical leadership, evaluates regulatory and operational impacts, leads cross‑functional teams, and mentors staff while ensuring inspection readiness and

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 5+ years GMP pharma or biologics experience.
• Extensive GMP lab experience and quality systems.
• Proven change control, investigations, regulatory compliance.
• Experience leading cross-functional initiatives.
• Ability to adopt new technologies and methods.
• Strong analytical, problem-solving and leadership skills.
• Excellent technical writing and stakeholder comms.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Execute GMP change control processes for laboratory testing.
• Own analytical change activities and coordinate milestones; SPR as SME.
• Ensure change control aligns with SOPs, specs, and regulations.
• Provide scientific and technical leadership for change initiatives.
• Evaluate regulatory, compliance, operational, and technical impacts.
• Lead cross-functional teams through change planning and execution.
• Develop and implement improvements to change management.
• Review complex change records and supporting documentation.
• Lead root-cause investigations for quality issues.
• Interpret regulatory expectations and propose solutions for inspections.
• Author and review technical reports, procedures, and regulatory docs.
• Mentor laboratory and quality personnel.

Skills

GMP

Change control

Regulatory compliance

Quality systems

Leadership

Technical writing

Analytical thinking

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences

Job 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.

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.