Manufacturing Specialist

Compliance Specialist II (Manufacturing/Quality) 1st Shift1 YearNorthborough, MAJob ResponsibilitiesThis position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMP's to support Label and Packaging operations, finished goods and raw material disposition.Responsibilities include:Performing finished product disposition in accordance with company's SOP's, in-house product specifications and market regulationsReviewing and approving validation protocols and change controlsAuthoring, revising and reviewing SOP's through Veeva SystemUtilizing Veeva to complete investigation of deviations, CAPAs and Change ControlsSupporting compliance walkthroughs, Participate in internal auditsParticipate in QA audit readiness program as well as assist and participate in external audits and regulatory inspectionsInterpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trendsCompleting analysis, identifying issues and providing recommendations for compliance improvementsCompleting Quality Events in VeevaDevelopment and training of new staff as neededParticipate in specialized projects both within Quality and cross-functionallyPerform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lotsSupport additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming MaterialsEffectively demonstrates an understanding of GMPs & how it applies to specific responsibilitiesMaintaining material master data in ERP systemFollowing accurate oral & written procedures in performing QA tasksStaying up-to-date on training of all proceduresRoutinely and safely handle high value product vials in various stages of packaging completionAdhering to company's safety procedures and guidelinesParticipate in Lean initiatives to improve Quality processesParticipate in the QA consistency meetings to support continuous improvement effortsSupport the QA on the floor initiatives which includes; attending daily capacity management and +QDCI meetings and assisting customers with resolution of issues in real timeEffectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashionEnsure that department goals are achieved and on time Quality product is released through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)Comply with the requirements of company's health and safety program.Education & Qualifications• Education: Bachelor's in Chemistry or Biology highly preferred but open to a BA in other sciences• Must-Have Experience with: SAP, GMP, industry experience in quality control/manufacturing• Preferred Experience: VEEVA• Work Experience: minimum 4-5 (academia or industry)

Created: 2025-02-08