Senior Compliance Specialist & Technical Writer

• 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.