Pharmalearner
Compliance Specialist III || Framingham, MA || Type-16 month Contract ||$40-45/h
Pharmalearner, Framingham, Massachusetts, us, 01704
Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi’s Framingham Biologics facilities. QA’s main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi’s Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company’s business and global markets.Position Overview with Key ResponsibilitiesThe Principal Compliance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Principal Compliance Specialist may also be responsible for providing leadership to the QA team in the absence of the manager.Core Responsibilities:
Function as shift lead including developing junior employeesPerform batch record reviewPerform review of column packing and qualification recordsReview and sign-off on manufacturing supervisor notesReview and approve CRs related to EBRs (as applicable)Function as SME on challenges related to production requiring a quality inputNon-conforming material discardPerform log book reviewProvide on the floor (OTF) support to the operations department, including OTF support for critical operations stepsIssue action notices and conduct affiliated provisional releaseConduct log book audits against compliance requirementsReview CV related documentation against specificationPerform Bulk Raw Material ReleasePerform media / buffer and intermediate releasePerform release of Cell Banks for forward processing (as applicable)Support cross-functional internal audit activities and conduct walkthrough inspectionsFunction as department lead for internal auditsFunction as CAPA ownerExecute containment activitiesProvide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRsFunction as document owner as neededMaintain a high level of personal compliance to the required standardsPartner with manufacturing and support operations to ensure a culture of continuous complianceMay provide training to new employeesReview of Quality Critical Alarms and NRSRInitiate and investigate and QA review deviationsProvide off-hour support for batch record and log book issuanceRepresent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA)Function as back-up for QA ManagerOther activities as assignedLeadership QualificationsAn ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.Being honest and treating people with respect and courtesy.Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.Coaching and mentoring QA personnel including QA Ops customers.Flexible and adaptable to changes and support business needs.Basic QualificationsMaster’s Degree & 4 years of experience, Bachelor’s Degree and 6 years of experience, Associate’s Degree and 8 years of experience, or a High School Diploma and 10 years of experience in a Quality and/or other cGMP related field.• 2 years of experience in a Quality role.• Working experience in external agency regulatory audits (FDA, EMA, etc.).• Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations.• Prior experience leading teams or projects.• Knowledge in external agency regulations (FDA, EMA, etc.).• Strong computer, verbal and written communication skills.• Experience in quality systems.• Experience in leading cross functional teams.• Experience with Trackwise or equivalent system.• Proficient in Microsoft Office.Preferred Qualifications• Bachelor’s degree in a scientific field with 6+ years of experience in a Quality and/or cGMP environment.• 4+ years of experience in a Quality Assurance role.• Experience in bio-pharmaceutical industry.• Capable of analyzing trends and metrics that lead to improvement.• Strong technical writing skills.• Effective time management, attention to detail, organizational skills, teamwork and collaboration.• Significant capability in problem solving methodology.• Experience working in an environment of operational excellence.• Experience training and developing employees.• Experience participating in external agency inspections.• Knowledge of regulatory enforcement trends.• Ability to work independently.Special Working Conditions• Ability to gown and gain entry to manufacturing areas• Ability to work a 12-hour rotating shift and every other weekend, including some holidays• Ability to lift 10 lbs.
#J-18808-Ljbffr
Function as shift lead including developing junior employeesPerform batch record reviewPerform review of column packing and qualification recordsReview and sign-off on manufacturing supervisor notesReview and approve CRs related to EBRs (as applicable)Function as SME on challenges related to production requiring a quality inputNon-conforming material discardPerform log book reviewProvide on the floor (OTF) support to the operations department, including OTF support for critical operations stepsIssue action notices and conduct affiliated provisional releaseConduct log book audits against compliance requirementsReview CV related documentation against specificationPerform Bulk Raw Material ReleasePerform media / buffer and intermediate releasePerform release of Cell Banks for forward processing (as applicable)Support cross-functional internal audit activities and conduct walkthrough inspectionsFunction as department lead for internal auditsFunction as CAPA ownerExecute containment activitiesProvide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRsFunction as document owner as neededMaintain a high level of personal compliance to the required standardsPartner with manufacturing and support operations to ensure a culture of continuous complianceMay provide training to new employeesReview of Quality Critical Alarms and NRSRInitiate and investigate and QA review deviationsProvide off-hour support for batch record and log book issuanceRepresent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA)Function as back-up for QA ManagerOther activities as assignedLeadership QualificationsAn ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.Being honest and treating people with respect and courtesy.Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.Coaching and mentoring QA personnel including QA Ops customers.Flexible and adaptable to changes and support business needs.Basic QualificationsMaster’s Degree & 4 years of experience, Bachelor’s Degree and 6 years of experience, Associate’s Degree and 8 years of experience, or a High School Diploma and 10 years of experience in a Quality and/or other cGMP related field.• 2 years of experience in a Quality role.• Working experience in external agency regulatory audits (FDA, EMA, etc.).• Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations.• Prior experience leading teams or projects.• Knowledge in external agency regulations (FDA, EMA, etc.).• Strong computer, verbal and written communication skills.• Experience in quality systems.• Experience in leading cross functional teams.• Experience with Trackwise or equivalent system.• Proficient in Microsoft Office.Preferred Qualifications• Bachelor’s degree in a scientific field with 6+ years of experience in a Quality and/or cGMP environment.• 4+ years of experience in a Quality Assurance role.• Experience in bio-pharmaceutical industry.• Capable of analyzing trends and metrics that lead to improvement.• Strong technical writing skills.• Effective time management, attention to detail, organizational skills, teamwork and collaboration.• Significant capability in problem solving methodology.• Experience working in an environment of operational excellence.• Experience training and developing employees.• Experience participating in external agency inspections.• Knowledge of regulatory enforcement trends.• Ability to work independently.Special Working Conditions• Ability to gown and gain entry to manufacturing areas• Ability to work a 12-hour rotating shift and every other weekend, including some holidays• Ability to lift 10 lbs.
#J-18808-Ljbffr