Senior Compliance Specialist & Technical Writer

Eurofins USA PSS Insourcing Solutions•West Point, PA

About The Position

The Senior Compliance Specialist & Technical Writer leads technical-writing activities for the Compliance team, including procedures, process flows, regulatory and audit responses, and reports related to trending, deviations, investigations, and validation. The role leads quality-process improvements to strengthen GxP testing operations, systems, procedures, and documentation practices, and conducts detailed reviews of laboratory data and in-lab processes to support GxP data integrity, accuracy, completeness, and quality. The position collaborates with Quality Assurance to maintain alignment with company policies and applicable federal regulations and to support inspection readiness. It participates in regulatory inspections and internal Quality Assurance audits, including preparation and follow-up. The role monitors laboratory operations and quality metrics, identifies trends, and drives process and procedural improvements. It also evaluates system data integrity and end-to-end data flows, identifies opportunities for enhancement or modernization, and participates in validation of computer and laboratory systems. The specialist develops or updates procedures for documentation and process reviews, leads training and coaches staff on SOP adherence, documentation requirements, procedures, assays, and laboratory systems, and participates in or leads initiatives that strengthen quality operations and support the setup of a new facility and laboratories. This is a full-time, Monday–Friday position with hours of 8 a.m. to 5 p.m. Candidates within commuting distance of West Point, Pennsylvania are encouraged to apply.

Requirements

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, 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 ability to manage multiple priorities.
Adherence to applicable safety procedures in a BSL-2 laboratory.

Nice To Haves

Experience in a GxP bioanalytical or clinical testing laboratory.
Experience with Laboratory Information Management Systems, electronic laboratory notebooks, and other scientific applications.

Responsibilities

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 preparation and follow-up activities.
Monitor laboratory operations and quality metrics, identify trends, and drive related process and procedural improvements.
Evaluate system data integrity and end-to-end data flows, identify enhancement or modernization opportunities, and participate in validation of computer and laboratory systems.
Develop 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 or lead internal initiatives that strengthen quality operations and support the setup of the new facility and laboratories.