Senior Compliance Specialist & Technical Writer

Job Description

• 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.

Qualifications

• 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.

Additional Information

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.