Technical Writer II

Artech Information System LLC; Northborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A prominent IT staffing firm is seeking a candidate for a lab-focused role requiring a bachelor's degree in a related field and at least 5 years of experience in a cGMP laboratory environment. The ideal candidate will ensure the quality of QCRM documents and support regulatory inspections. Responsibilities include providing training and coordinating lab equipment tasks. This role is essential for maintaining safety and compliance in laboratory operations.

Qualifications

• Minimum of 5 years of experience in cGMP laboratory environment.
• Previous experience with lab control operations and quality systems.

Responsibilities

• Ensure timely and efficient creation/review of QCRM documents.
• Provide training and ensure proficiency of QCRM staff.
• Support readiness for regulatory inspections and compliance audits.
• Coordinate and conduct laboratory equipment tasks.

Skills

Analytical skills

Ability to manage lab equipment

Knowledge of cGMP regulations

Experience with quality systems

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

Key Responsibilities:

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

Skills:

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

Qualifications

Bachelor s degree in a related discipline

Previous experience with lab control operations and quality systems

Additional Information

Regards,

Akriti Gupta

Associate Recruiter(Scientific & Clinical Division)

Artech Information Systems LLC

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

Office: 973.967.3409 | Fax: [phone]

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