Artech Information System LLC
Technical Writer II
Artech Information System LLC, Northborough, Massachusetts, us, 01532
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.
Is this the role you are looking for If so read on for more details, and make sure to apply today.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 documentEnsure a consistent style of presentation of QCRM documents to maintain quality and ease of reviewExecute activities associated with optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materialsCoordinate and conduct tasks for laboratory equipment calibration, qualification, preventative maintenance and re-qualification programAct 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 resultsSupport readiness for regulatory inspections and compliance audits.Assess routine compendial updates and ensure timely revision of test methodsReview data generated by contract laboratories (internal and external labs)Support development of junior analysts through mentoringExecute and ensure timely closure of compliance events, including deviations, CAPA, change controlsRevise standard operating procedures as neededPractice safe work habits and adhere to Genzyme's safety procedures and guidelinesMaintain proficiency training per assigned curriculaSkills:Bachelor's degree in a related disciplineMinimum of 5 years of experience in cGMP laboratory environmentPrevious experience with management of lab equipmentPrevious experience with lab control operations and quality systemsQualifications
Bachelor's degree in a related disciplinePrevious experience with lab control operations and quality systemsAdditional Information
Regards,Akriti GuptaAssociate Recruiter (Scientific & Clinical Division)Artech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960Office: 973.967.3409 | Fax: 973.998.2599Connect with us on - LinkedIn | Facebook | Twitter
#J-18808-Ljbffr
Is this the role you are looking for If so read on for more details, and make sure to apply today.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 documentEnsure a consistent style of presentation of QCRM documents to maintain quality and ease of reviewExecute activities associated with optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materialsCoordinate and conduct tasks for laboratory equipment calibration, qualification, preventative maintenance and re-qualification programAct 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 resultsSupport readiness for regulatory inspections and compliance audits.Assess routine compendial updates and ensure timely revision of test methodsReview data generated by contract laboratories (internal and external labs)Support development of junior analysts through mentoringExecute and ensure timely closure of compliance events, including deviations, CAPA, change controlsRevise standard operating procedures as neededPractice safe work habits and adhere to Genzyme's safety procedures and guidelinesMaintain proficiency training per assigned curriculaSkills:Bachelor's degree in a related disciplineMinimum of 5 years of experience in cGMP laboratory environmentPrevious experience with management of lab equipmentPrevious experience with lab control operations and quality systemsQualifications
Bachelor's degree in a related disciplinePrevious experience with lab control operations and quality systemsAdditional Information
Regards,Akriti GuptaAssociate Recruiter (Scientific & Clinical Division)Artech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960Office: 973.967.3409 | Fax: 973.998.2599Connect with us on - LinkedIn | Facebook | Twitter
#J-18808-Ljbffr