Senior Compliance Specialist & Technical Writer

📋 Description

• Lead technical-writing activities for the Compliance team, including procedures, process flows
• Lead quality-process improvements that strengthen GxP testing operations, systems, procedures, and
• Conduct detailed laboratory data and in-lab process reviews to support the integrity, accuracy
• Collaborate with Quality Assurance to maintain alignment with company policies and applicable
• Participate in regulatory inspections and internal Quality Assurance audits, including related
• Monitor laboratory operations and quality metrics, identify trends, and drive related processes and

🎯 Requirements

• Expertise in technical writing, including reports and controlled procedures.
• Experience conducting, auditing, and supporting GxP laboratory documentation, protocols, and
• 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.

🎁 Benefits

• 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