Quality Operations Specialist

 Responsibilities:Support the overall effort of Quality Assurance and the Product Development & Manufacturing team to develop new products in collaboration with external clientsFacilitate root cause analysis as part of exception investigations and incorporate the results into investigation documentationWrite, review and edit technical documentation (batch records, material specifications, etc.) in collaboration with PD&M personnel to assist in the development and qualification of commercial and clinical productsWork collaboratively with engineers project teams as needed to develop manufacturing work instructions, product specifications and validation documentsTrack document review and approval routings, accurately track the status of multiple documents simultaneouslyPrepare and route documents for approval ensuring compliance with Good Documentation Practices (GDP) and FDA requirementsInterface with multiple internal disciplines including manufacturing, analytical, supply chain etc.Occasionally interface with external suppliers and customersAssist in the execution of project plans to satisfy required actions, milestones and deadlinesProvide training to other team members as neededAdhere to and ensure compliance with Quality System Standard Operating Procedures (SOP's), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and FDA requirementsRequirements:Working knowledge of regulated manufacturing environmentsExperience conducting / facilitating root cause analysis using standardized toolsAbility to create a variety of manufacturing and engineering documents including production batch records, specifications and test plansStrong command of English language including editing and proofreading skills, spelling, grammer and punctuationGreat attention to detail and the ability to communicate well across functions and organizational levelsCapable of organizing information into a clear and concise written formAbility to multitask and work in a deadline driven environmentAbility to work independently as well as with a teamExcellent command of Microsoft Office Suite, especially Word and ExcelBachelor's Degree in a technical discipline (preferred) or equivalent combination of education and professional experienceApply (by clicking the relevant button) after checking through all the related job information below. PIe21348be6ae9-30134-38452304

Created: 2025-10-01