Senior Technical Writer, cGMP Lab Documentation

Artech Information System LLC; Northborough (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing company is seeking experienced professionals for a role focused on cGMP laboratory operations. You will review QCRM documents, ensure compliance with quality systems, and provide training on analytical methodologies. The ideal candidate has at least 5 years of lab experience and a Bachelor's degree in a related field. This position involves coordination of equipment management and regulatory readiness, making it critical for maintaining high-quality standards in laboratory testing.

Qualifications

• Minimum of 5 years of experience in a cGMP laboratory environment.
• Previous experience with management of lab equipment.
• Strong analytical skills and understanding of test results.

Responsibilities

• Ensure timely and efficient creation/review of QCRM documents.
• Coordinate laboratory equipment calibration and qualification.
• Provide training to QCRM staff on analytical methods.
• Support readiness for regulatory inspections.

Skills

cGMP laboratory experience

Lab equipment management

Quality systems

Analytical skills

Education

Bachelor's degree in a related discipline

Job description

A leading IT staffing company is seeking experienced professionals for a role focused on cGMP laboratory operations. You will review QCRM documents, ensure compliance with quality systems, and provide training on analytical methodologies. The ideal candidate has at least 5 years of lab experience and a Bachelor's degree in a related field. This position involves coordination of equipment management and regulatory readiness, making it critical for maintaining high-quality standards in laboratory testing.