Supervisor, Quality Assurance - Allston, MA

Company: National Resilience
Location: Malden
Posted on: January 4, 2022

Job Description:

Quality Assurance (QA) is responsible for quality oversight of operations at Allston Landing facility, a large scale manufacturing facility.The main role of QA within the organization is to provide an independent oversight of operations, inclusive of the production areas and Quality Control laboratories, to ensure that CGMPS are maintained and quality product is manufactured.In order to achieve this QA reviews and approves Batch Records, Deviations, Laboratory Investigations, CAPAs Change Controls Requests, Document Change Requests, effectiveness reviews as well as associated documentation in support of----Preventive/Corrective----Maintenance, Metrology, Automation Engineering, Validation and dispositions intermediates and Drug Substance, and provides QA on the floor presence.Job ResponsibilitiesPerform record issuance and review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA.Conduct review of manufacturing processes to ensure compliance. Conduct review of testing results in support of release of intermediates.Provide compliance guidance and direction to QA and manufacturing support teams.Participate in bulk shipment oversight activities.Participate in Quality release activities of manufactured intermediates.Work closely with manufacturing groups to support all deviations within agreed timelines.Complete the OJT for All deviation classifications for investigating deviations within the QA cost center.Perform deviation investigation activities, including; GEMBA, containment, classification and initial impact assessment.Perform----deviation/nonconformance----investigations.May act as team lead to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.Work closely with manufacturing and support groups to develop effective CAPA to reduce deviation reoccurrence and for continuous improvement.Perform deviation review to ensure compliance of investigations to in-house specifications and government regulations.Responsible for management oversight of several direct reports and administering work load to ensure all department related activities and timelines are met,Participate in goal setting, performance and talent reviews and career development of personnel.QualificationsStrong technical writing skills.Fully versed in CGMP, ICH, EMA and FDA rules, guidance and expectations. Experience in on the job training and authoring SOPs.Experience with using operational excellence tools to drive continuous improvementStrong computer, verbal and written communication skills.Preferred Experience----Master's degree and 4 years of experience, or Bachelor's degree and 6 years of experience, or Associate's degree and 8 years of experience or 6 years of experience in the BioTech / Pharmaceutical IndustryExperience managing teams is preferredPandoLogic. Keywords: Quality Control / Quality Assurance Supervisor, Location: Malden, MA - 02148

Keywords: National Resilience, Malden , Supervisor, Quality Assurance - Allston, MA, Other , Malden, Massachusetts