Technical Writer

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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• Ensure timely and efficient creation/review of QCRM documents (material specifications, standard operating procedures, test methods, technical protocols and reports, etc.) Contribute scientific knowledge, analytical skills, and interpretation of the information to be captured on the document
• Ensure a consistent style of presentation of QCRM documents to maintain quality and ease of review Execute activities, associated with optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials
• Coordinate and conduct tasks for laboratory equipment calibration, qualification, preventative maintenance and re-qualification program Act as subject matter expert (SME) for method validation, laboratory equipment management and supplier certification testing, and provide input in cross-functional teams, including during Consent Decree remediation activities.
• Provide training and ensure adequate proficiency of QCRM staff with respect to analytical method principle and critical parameters; ensure understanding and interpretation of test results Support readiness for regulatory inspections and compliance audits.
• Assess routine compendial updates and ensure timely revision of test methods Review data generated by contract laboratories (internal and external labs) Support development of junior analysts through mentoring
• Execute and ensure timely closure of compliance events, including deviations, CAPA, change controls Revise standard operating procedures as needed Practice safe work habits and adhere to Genzyme s safety procedures and guidelines
• Maintain proficiency training per assigned curricula

Qualifications

Skills: Basic Qualifications: Bachelor s degree in a related discipline Minimum of 5 years of experience in cGMP laboratory environment Previous experience with management of lab equipment Previous experience with lab control operations and quality systems

Education: Bachelor s degree in a related discipline Previous experience with lab control operations and quality systems .

Additional Information

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960

Office: 973.967.3348 | Fax: [phone]

Connect with us on - LinkedIn | Facebook | Twitter