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
Bachelor s degree in a related discipline
Previous experience with lab control operations and quality systems
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: 973.998.2599
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Job details are sourced from the employer's original posting.
Open job postingAbout the company
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com