Pharmalearner
Compliance Specialist II || Framingham, MA || Type-16 month Contract ||$28-30/hr
Pharmalearner, Framingham, Massachusetts, us, 01704
Description: The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at Sanofi Framingham Biologics facilities. QA’s main responsibility is to ensure adherence to CGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. 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 Responsibilities:Core ResponsibilitiesThe Senior Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team.Actively supports the QA Operations team by providing technical supportCompletes Phenix/Trackwise Laboratory Investigations/Deviations/ CAPA/Change ControlsEnsure all safety requirements are being metPerforms batch record and logbook reviewPerforms review of column packing and qualification recordsReview and approve CRs related to EBRsFunction as SME on challenges related to production requiring quality inputProvide 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 media / buffer and intermediate releasePerform release of Cell Banks for forward processing (as applicable)Support cross-functional internal audit activities and conduct walkthrough inspectionsExecute containment activitiesProvide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRsMaintain a high level of personal compliance to the required standardsPartner with manufacturing and support operations to ensure a culture of continuous compliance
Basic Qualifications:
Master’s Degree & 2 years of experience or Bachelor’s Degree and 4 years of experience in a Quality and/or other cGMP related field.Knowledge in external agency regulations (FDA, EMA, etc.)Strong computer, verbal and written communication skills.Experience in quality systems.Experience with Trackwise or equivalent system.Proficient in Microsoft Office
Preferred Qualifications:
Operations experience in one of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems.Experience with root cause analysis tools.Demonstrated experience with change control, CAPA and deviation quality systems.Experience in a Quality Assurance role.Strong technical writing skills.Effective time management, attention to detail, organizational skills, teamwork and collaboration.Significant capability in problem solving methodology.Experience training and technically 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 and Quality Control areas.Ability to work a 12-hour rotating shift and every other weekend, including holidays.Ability to lift 10 lbs.
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Position Overview with Key Responsibilities:Core ResponsibilitiesThe Senior Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team.Actively supports the QA Operations team by providing technical supportCompletes Phenix/Trackwise Laboratory Investigations/Deviations/ CAPA/Change ControlsEnsure all safety requirements are being metPerforms batch record and logbook reviewPerforms review of column packing and qualification recordsReview and approve CRs related to EBRsFunction as SME on challenges related to production requiring quality inputProvide 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 media / buffer and intermediate releasePerform release of Cell Banks for forward processing (as applicable)Support cross-functional internal audit activities and conduct walkthrough inspectionsExecute containment activitiesProvide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRsMaintain a high level of personal compliance to the required standardsPartner with manufacturing and support operations to ensure a culture of continuous compliance
Basic Qualifications:
Master’s Degree & 2 years of experience or Bachelor’s Degree and 4 years of experience in a Quality and/or other cGMP related field.Knowledge in external agency regulations (FDA, EMA, etc.)Strong computer, verbal and written communication skills.Experience in quality systems.Experience with Trackwise or equivalent system.Proficient in Microsoft Office
Preferred Qualifications:
Operations experience in one of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems.Experience with root cause analysis tools.Demonstrated experience with change control, CAPA and deviation quality systems.Experience in a Quality Assurance role.Strong technical writing skills.Effective time management, attention to detail, organizational skills, teamwork and collaboration.Significant capability in problem solving methodology.Experience training and technically 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 and Quality Control areas.Ability to work a 12-hour rotating shift and every other weekend, including holidays.Ability to lift 10 lbs.
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