Eurofins Lancaster Laboratories

Change Control Specialist

Eurofins Lancaster Laboratories • $80K — $95K *
West Point, PA 19486In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Biology, Chemistry, Microbiology, or related field.
  • Minimum 5 years of GMP experience in pharmaceuticals, biologics, or laboratory operations.
  • Extensive experience in GMP laboratories, quality systems, or the pharmaceutical industry.
  • Proven expertise in change control, quality investigations, and regulatory compliance.
  • Experience managing complex technical projects across departments.
  • Ability to implement new technologies and methodologies effectively.
  • Strong analytical, problem-solving, organizational, and leadership skills.
  • Excellent in technical writing and stakeholder communication.
  • Authorization to work in the US indefinitely without restrictions.

Responsibilities

  • Execute GMP change control processes for laboratory testing.
  • Own analytical change activities for change control requests and ensure proactive communication.
  • Ensure compliance with specifications, procedures, and SOPs during the change control process.
  • Provide scientific and technical leadership for complex change control initiatives.
  • Evaluate the operational and regulatory impact of proposed laboratory changes.
  • Lead cross-functional teams through change planning and execution.
  • Develop and implement improvements to change management processes.

Benefits

  • Comprehensive medical coverage
  • Dental and vision options
  • Life and disability insurance
  • 401(k) with company matching
  • Paid vacation and holidays
Full 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

About Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
Learn more about Eurofins Lancaster Laboratories
Size
12,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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