Senior Compliance Specialist & Technical Writer
Posted
Summary
Leads technical writing and compliance documentation for Eurofins' GxP laboratory operations in West Point, PA — authoring SOPs, audit/regulatory responses, and investigation reports, while driving quality-process improvements, coaching staff, and supporting inspections and computer/laboratory system validation.
- Lead technical-writing activities for the Compliance team, including procedures, process flows, regulatory and audit responses, and reports associated with trending, deviations, investigations, and validation.
- Lead quality-process improvements that strengthen GxP testing operations, systems, procedures, and documentation practices.
- Conduct detailed laboratory data and in-lab process reviews to support the integrity, accuracy, completeness, and quality of GxP data.
- Collaborate with Quality Assurance to maintain alignment with company policies and applicable federal regulations and support ongoing inspection readiness.
- Participate in regulatory inspections and internal Quality Assurance audits, including related preparation and follow-up activities.
- Monitor laboratory operations and quality metrics, identify trends, and drive related processes and procedural improvements.
- Evaluate system data integrity and end-to-end data flows, identify opportunities for enhancement and/or modernization, and participate in validation of computer and laboratory systems.
- Develop and/or update procedures supporting documentation reviews and process reviews.
- Lead training and coach department staff on adherence to SOPs, documentation requirements, procedures, assays, and laboratory systems.
- Participate in and/or lead internal initiatives that strengthen quality operations and support the setup of the new facility and laboratories.
- Expertise in technical writing, including reports and controlled procedures.
- Experience conducting, auditing, and supporting GxP laboratory documentation, protocols, and testing.
- Experience leading process-improvement efforts in laboratory, quality, and/or compliance settings.
- Experience training staff in procedures, assays, and laboratory systems.
- Experience operating in a GxP laboratory environment.
- Strong critical-thinking, troubleshooting, verbal-communication, and written-communication skills.
- Ability to follow procedures and thoroughly document laboratory work.
- Ability to work independently with limited supervision and meet project timelines.
- Strong attention to detail and the ability to manage multiple priorities.
- Adherence to applicable safety procedures in a BSL-2 laboratory.
Preferred Experience & Skills
- Experience in a GxP bioanalytical or clinical testing laboratory.
- Experience with Laboratory Information Management Systems, electronic laboratory notebooks, and other scientific applications.
Position is full-time, Mon-Fri 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.