Eurofins Lancaster Laboratories

Senior QA Specialist

Eurofins Lancaster Laboratories • $75K — $95K *
Portage, MI 49024In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific discipline
  • 4+ years of QA experience within a pharmaceutical or regulated laboratory environment
  • Proven experience with investigations and CAPA management
  • Experience hosting audits (client and/or regulatory)
  • Strong working knowledge of GxP (GMP/GLP) regulations
  • Excellent written and verbal communication skills
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint)

Responsibilities

  • Lead deviation and investigation writing/review, including root cause analysis and CAPA development
  • Review and approve quality agreements for regulatory and client compliance
  • Host and support external audits by regulatory agencies and clients
  • Conduct internal audits and ensure audit readiness across laboratory operations
  • Perform risk assessments to identify and mitigate quality risks
  • Drive data integrity compliance initiatives adhering to ALCOA+ principles
  • Manage change control processes with compliance and impact assessments

Benefits

  • Comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
Full Job Description






Job Description
  • Lead and perform deviation and investigation writing/review, including thorough root cause analysis and CAPA development/effectiveness checks
  • Review and approve quality agreements and ensure alignment with regulatory and client requirements
  • Host and support external audits, including regulatory agency inspections and client audits
  • Conduct internal audits, walkthrough inspections, and ensure audit readiness across laboratory operations
  • Perform and support risk assessments to proactively identify and mitigate quality risks
  • Drive data integrity compliance initiatives, ensuring adherence to ALCOA+ principles
  • Manage and support change control processes, ensuring impact assessments and compliance with procedures
  • Review and approve SOPs, analytical methods, protocols, and reports
  • Release and ensure accuracy of analytical reports
  • Contribute to monthly and quarterly quality metrics reporting
  • Identify and implement continuous improvement opportunities within QA and laboratory functions
  • Partner cross-functionally with laboratory staff, clients, and leadership to ensure quality objectives are met
  • Maintain a strong commitment to safe, compliant, and efficient operations


Qualifications
  • Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific discipline
  • 4+ years of QA experience within a pharmaceutical or regulated laboratory environment
  • Proven experience with:
    • Investigations and CAPA management
    • Audit hosting (client and/or regulatory)
    • Quality systems (change control, deviations, document control)
    • Data integrity principles and compliance expectations
  • Strong working knowledge of GxP (GMP/GLP) regulations
  • Excellent written and verbal communication skills
  • Ability to confidently interact with clients, auditors, and internal stakeholders
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint)
  • Authorization to work in the U.S. without sponsorship


Additional Information

Position is full time, Monday to Friday, 8AM - 5PM. Candidates currently living within a commutable distance of Portage, MI 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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