About this role
The Specialist QA performs a broad range of Quality Assurance activities under minimal supervision, ensuring compliance with cGMP requirements, internal procedures, and regulatory expectations. This role provides on‑the‑floor oversight, documentation review, quality system support, and cross‑functional collaboration to maintain product quality and operational excellence. FUNCTIONS Review and approve product MPs, process validation protocols, and manufacturing reports.
Perform on‑the‑floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, batch records, MES/EBR, SAP, EDMQ, DQMS, Trackwise documentation, deviations, CAPAs, and validations. Participate in incident triage teams and ensure deviation initiation, documentation, and procedural compliance. Approve Environmental Characterization reports and release sanitary utility systems.
Approve planned incidents, NC investigations, CAPA records, and change controls. Lead investigations, audits, and support internal/external inspections as part of the audit management team. Represent QA in New Product Introduction (NPI) activities and provide quality oversight for new products.
Own and maintain site quality program procedures; act as designee for QA leadership on CCRB. Review risk assessments and support automation, facilities, environmental, and engineering programs. Review and approve Work Orders and EMS/BMS alarms.
Provide lot disposition and authorize lots for shipment. Ensure production records and testing results are complete, accurate, and compliant with cGMP. Coordinate testing with contract laboratories and vendors; review external lab data for accuracy and compliance.
Support commissioning, qualification, and validation activities (IQ/OQ/PQ, Validation Master Plans, protocols, test scripts, summary reports). Serve as a strategic advisor regarding quality, compliance, supply, and safety risks. Champion continuous improvement initiatives, programs, and projects.
Maintain adherence to assigned training requirements. Collaborate cross‑functionally with Manufacturing, Process Development, Validation, QC, Warehouse, Engineering, Facilities, Environmental, Contractors, and other stakeholders.
EDUCATION Doctorate OR Master’s + 2 years of directly related experience OR Bachelor’s + 4 years of directly related experience OR Associate’s + 8 years of directly related experience OR High School/GED + 10 years of directly related experience. PREFERRED QUALIFICATIONS Experience in Change Control, Documentation Review, Validation, PPQ. Demonstrated expertise in Quality Systems (deviations, CAPA, change control).
Experience with computer systems validation or computer systems QA (medical device or consulting background preferred). Strong knowledge of manufacturing, distribution, QA, QAL, and Process Development processes. Experience with GxP application validation and compliance documentation.
Proven ability to lead, influence, and negotiate across teams. Strong organizational skills and ability to follow assignments through to completion. Ability to interact effectively with regulatory agencies.
Strong communication skills in English and Spanish (written and oral). Advanced data trending, evaluation, and compliance assessment skills. Ability to work independently and interact effectively at all organizational levels.
Administrative shift. 6‑month contract with possible extension.