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Associate II, Quality Assurance - R-100842 - Allston, MA

Company: National Resilience
Location: Somerville
Posted on: January 10, 2022

Job Description:

Quality Assurance (QA) is responsible for quality oversight of operations at Allston Landing facility, a large-scale therapeutic protein 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. 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.The shift schedule is Wednesday - Saturday, from 7-5PM.ResponsibilitiesAdhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.Acting with integrity and treating people with respect and courtesy.Act as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgement in performing our jobs.This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's. The responsibilities include but are not limited to:Operations Responsibilities: Perform 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.Lot/ Intermediate Disposition Responsibilities:Participate in bulk shipment oversight activities.Participate in Quality release activities of manufactured intermediates.Deviation/CAPA Management Responsibilities: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.Perform final impact assessments to determine potential impact to product SISPQ to internal and external requirements.May provide compliance guidance and direction to QA and Manufacturing support teams.May approve management activities in Quality Management systems (ie. Trackwise/Phenix).May facilitate department regulatory related CAPAs and audit responses.May provide real time QA input to enable effective, compliant solutions to emerging issues in the manufacturing areas.Quality Engineering Responsibilities:Work with functional groups across the site to review and approve quality and technical documentation including deviations, CAPAs, Action Notices (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of-- -Preventive/Corrective-- -Maintenance, Metrology, Automation Engineering and Validation.Review unscheduled maintenance and facility alarms, specifically the return to service testing and assessing potential impact to product.Provide support for visual inspections of vessel surfaces, when required.Provide support for the development of robust maintenance procedures.Review automation call/event logs to identify opportunities for training, process improvement and assess product impact.Provide support to ensure automation changes are promptly removed to ensure system configuration and validation status are maintained.Review, approve and act as owner of department-controlled documents and processes ensuring compliance and adherence to requirements.Provide support in developing training strategies and materials that supports continuous improvement of processes and provide to end users.Participate in the QA consistency meetings to drive continuous improvement efforts.Participant in internal audits.Participate in the QA consistency meetings to drive continuous improvement efforts.Participant and/or lead in QA audit readiness program as well as assist and participant in external audits and regulatory inspections.Participant in QA audit readiness program as well as assist and participant in external audits and regulatory inspections.Participant or may lead in Lean initiatives to improve Quality processes.Effectively interact on a cross functional basis providing QA guidance at the area level and escalate any issues to Management in a timely fashion.May act as a change owner for QA change controls.May act as the change owner for QA document changes.Ensure that department goals are achieved and on time Quality product is realized through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)QualificationsMaster'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 IndustryPreferred QualificationsFully 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 improvement Strong computer, verbal, and written communication skills.Strong technical writing-- -skills.Experience managing-- -teams.PandoLogic. Keywords: Quality Control / Quality Assurance Analyst, Location: Somerville, MA - 02145

Keywords: National Resilience, Somerville , Associate II, Quality Assurance - R-100842 - Allston, MA, Other , Somerville, Massachusetts

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