Senior Quality Specialist at TSR Consulting Services in Devens, MA
TSR Consulting Services, Inc.Devens, MA
Senior Quality Specialist
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a Senior Quality Specialist on a contracting basis. Work Location Devens MA
SummaryPerform and troubleshoot routine and advanced processing and data review of raw materials, in-process, batch release, andor stability samples of Bulk Drug Substance in a cGMP compliant environment Execute and improve procedures owned by the Sample Management functional area Author revisions to SOPs for managerial review and approval and drafts new documentation where appropriate May author protocols andor reports as required Train on multiple proceduresprocesses, and provide support to a wider spectrum of Sample Management responsibilities May be assigned as team leader overseeing day to day execution of a shift of junior analysts Required skills Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, supply chain, a related discipline, or the equivalent in related experience A minimum of 6 years of experience in cGMP Biologics QC laboratory or related cGLP or cGMP lab Proficiency (or mastery) of one or more of the methodologies within the QC sub-team Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints Proficiency in applying cGMP regulations and compendial testing required Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, ELN, Maximo or similar, DeltaV or similar, and Infinity or similar May represent QC Sub-team or functional area in cross functional teams or projects Frequent contact with Manufacturing and Stability organizations for troubleshooting and forecastingplanning Cross-sitevendor communications as needed for strategic purposes May be required to coordinate with site stakeholders for troubleshooting purposes Quality Assurance as necessary Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility and Stability commitments Flexibility to work irregular hours and short notice overtime Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested. Regards, Dianne Weiss Technical Recruiter 646-668-4249
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