Quality Assurance Specialist

QA SpecialistXseer Pharmaceuticals is hiring a QA Specialist for the Quality Assurance Group. This role combines daily QA support with independent work on investigations, CAPA, change control, and batch disposition. You will support sterile manufacturing and work with Manufacturing, QC, Facilities, Supply Chain, and QA Management.ResponsibilitiesReview executed batch records, logbooks, cleaning records, and component usage records; support batch disposition.Review and approve SOPs, controlled documents, test methods, forms, and labels within assigned authority.Initiate and investigate deviations, nonconformances, and out-of-specification or out-of-trend events; support or lead CAPA and effectiveness checks.Review change controls and support impact assessments and quality risk evaluations.Provide QA floor support for sterile compounding, filtration, filling, media fills, and packaging; perform walkthroughs and line clearance and label reviews.Review environmental monitoring records, QC data, trends, and facility and utility monitoring results.Support incoming material inspections, component release, vendor qualification, and supplier oversight.Support audits and inspections, prepare documentation, and train new employees on QA procedures, GDP, and quality systems.QualificationsAssociate degree required; bachelor's degree in a scientific or technical field preferred.2+ years of QA or cGMP experience in pharmaceutical, biotechnology, or 503B operations.Strong knowledge of cGMP, good documentation practices (GDP), aseptic processes, deviations, CAPA, and change control.Experience reviewing batch records and using electronic document management or quality management systems.Ability to conduct investigations independently, maintain accurate documentation, and work across departments with minimal supervision.Work environmentFacility and cleanroom work requires clean scrubs and appropriate PPE, extended sitting, standing, walking, computer use, and other physical activities. Duties include routine lifting up to 25 pounds, occasional lifting up to 50 pounds, and pushing or pulling carts or pallets with 100-200 pounds of force, unless a special provision applies. Physical duties may be performed with or without reasonable accommodation.Benefits:401(k)403(b)Dental insuranceHealth insuranceHealth savings accountLife insurancePaid time offVision insurance