QA Jobs in Manchester, NH

The QA Specialist I - Compliance provides administrative support to the Compliance team, coordinates audits, manages documentation, and ensures compliance during regulatory inspections.

Supervise QA Operations Associates providing seven-day GMP oversight for clinical and commercial drug product and medical device manufacturing. Guide line clearances, labeling, packaging, material release, batch record review, inspections, investigations, CAPA, SOPs, training, and quality systems. Partner with manufacturing and support functions to resolve compliance issues, support audits and regulatory inspections, maintain staff performance and training, and drive continuous process improvement.

Responsible for supplier quality management, compliance auditing, and quality metric reporting. Ensures adherence to FDA regulations and manages supplier agreements.

Manage supplier qualification for GMP suppliers: track and close audit observations, handle supplier non-conformances and change notifications, review audit responses, draft/manage QA and NDA agreements, support risk assessments, annual product quality reviews, quality system events, SOPs, documentation control, and continuous improvement while collaborating with corporate and cross-functional teams.

Perform batch record review, lot disposition, and quality system oversight to ensure cGMP and regulatory compliance. Lead investigations, CAPAs, change control, risk assessments, and quality improvement projects; support tech transfer, validations, and regulatory inspection readiness while interfacing with internal and external stakeholders.

Embed with cloud engineering teams to create and maintain IEC 62304-compliant software lifecycle documentation (SDP, SRS, SDD, V&V plans/reports, risk files), drive document change control and traceability, author SOPs and templates, coordinate documentation project plans and readiness reviews, and champion automation-first DevSecOps quality practices to keep releases audit-ready.

Provide QA oversight for batch record review, lot disposition, deviations/investigations, CAPAs, change control and quality system documentation to ensure cGMP compliance for clinical and commercial manufacturing. Lead risk assessments, support regulatory inspection readiness, and represent QA on cross-functional projects.

Manage and maintain cGMP documentation and electronic document management systems. Create, modify, approve, issue, and reconcile batch records and quality documents. Maintain master document lists and numbering logs, write SOPs, support audits, lead CAPA actions and continuous improvement projects, train staff, and support multiple production facilities as needed.

The job provides training and placement for QA and BA roles while targeting OPT/CPT students, fresh graduates, and visa holders. It requires good communication skills and offers competitive salaries.

I.T. Excel is offering training and placement opportunities for recent graduates in QA and Business Analysis, focusing on IT and Software Development.