["Quality Assurance Specialist II (QAOTF)","Quality Assurance Specialist II (QAOTF)"]

The Fountain Group is currently seeking a Quality Assurance Specialist II for a prominent client of ours. This position is located in Rockville, MD.QA Specialist IILocation: Onsite (5 days/week, M–F)Pay Rate: $26.50/hrDuration: 6 Months (Potential Temp-to-Perm)Job Description The QA Specialist II provides Quality Assurance oversight for GMP manufacturing operations supporting cell banks, bulk drug substances, plasmid products, and final drug products. Responsibilities include batch record review, batch disposition, deviation investigations, CAPA support, change control assessment, QA floor support, and compliance monitoring.Key responsibilities:Provide QA oversight for GMP manufacturing operations and client projectsReview executed batch records, QC reports, environmental monitoring data, logbooks, and cleaning recordsCompile batch disposition documentation for product release activitiesSupport deviation investigations, root cause analysis, non-conformance management, and CAPA implementationEvaluate and review change controls impacting manufacturing operationsPerform QA floor activities including line clearance, room release, and real-time documentation reviewConduct GMP audits and manufacturing walkthroughsReview and disposition raw materials according to approved proceduresIssue and control batch production records and labels through QA Document ControlEnsure SOP compliance and effectiveness through direct observationReview quality control testing documentation related to batch processingTrain junior QA staff and support continuous improvement initiativesEducation BS/BA in Life Sciences or a related scientific disciplineRequired Skills Minimum 5 years of GMP Quality Assurance experience within biopharmaceutical, pharmaceutical, or related regulated manufacturing environmentsGMP batch record review and batch disposition experienceDeviation management, root cause investigations, non-conformance handling, and CAPA implementationChange control review and quality systems supportQA floor support, line clearance, and room release activitiesProduct release documentation and raw material dispositionKnowledge of FDA, EMA, and ICH regulations and guidelinesQA auditing and manufacturing compliance assessmentsReview of QC testing documentation and environmental monitoring recordsSOP compliance and document control processesMicrosoft Excel, Word, PowerPoint, Access, and VisioPreferred Skills Experience with TrackWise DigitalExperience with Pilgrim quality management systemsExperience supporting cell bank, plasmid, biologics, or drug product manufacturing operations#J-18808-Ljbffr