About the role
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.