QA Analyst (Biotech)

Piper Companies is seeking a Quality Assurance Analyst to support a leading biotech organization in the Silver Spring, MD area. The QA Analyst will support GMP operations, documentation control, and quality system compliance. *This role is 100% on-site in Silver Spring.

Responsibilities of the QA Analyst:

·       Manage and maintain GMP documentation, including SOPs, batch records, forms, logbooks, protocols, and controlled documents.

·       Execute document change control processes, ensuring revisions, approvals, and archival are completed in compliance with internal procedures and regulatory expectations

·       Perform QA review and approval of batch record documentation, deviations, investigations, CAPAs, and quality event records to ensure data integrity and compliance

·       Participate in internal and external audits, providing documentation and support to ensure inspection readiness

·       Support Quality Management System (QMS) enhancements, including process improvements, training updates, and system optimization initiative

Qualifications of the QA Analyst:

·       1+ years of QA experience working in biotech, pharmaceutical, cell therapy or other GMP-regulated environment

·       Experience with document control systems (Veeva, MasterControl, TrackWise, EDMS, eQMS, etc.)

·       Strong GMP knowledge

·       Experience with CAPA deviations, batch record review/approval and assisting in document lifecycle responsibilities

·       platforms.

·       Background in root cause analysis, CAPA generation, and QMS process improvements.

·       Bachelor’s degree in Biology, Biotechnology, Life Sciences, Chemistry, Engineering, or related discipline

Compensation for the QA Analyst:

·       Salary: $60,000 - $85,000 annually, commensurate with experience

·       Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, PTO (Paid Time Off), Paid Holidays, Sick leave required as by law

This job opens for applications on 2/17/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

QA, Quality Assurance, QA Analyst, QA Specialist, Quality Assurance Specialist, Good Manufacturing Practice, GMP, GDP, GCP, GLP, ALCOA, CAPA, Corrective and Preventative Actions, Deviations, Nonconformance, Change Control, Batch Record, Veeva, Master Control, MasterControl, EDMS, EQMS, Quality Management System, QMS, Document Control, Document Lifecycle, Document Archival, Document Processing, TrackWise, Audit Readiness, ICH Guidelines, 21 CFR, FDA, Risk Assessment, Risk Mitigation, Root Cause Analysis, Document Change Management, SOP, Standard Operating Procedure, Controlled Documents, Logbook review, Electronic Document System, Electronic Batch Records, EBR, Good Documentation Practices, Manufacturing, Quality Control, In-Process, Quality Checks, Six Sigma, Continious Improvement, Upstream, Downstream, Deviation, CAPA investigation, QA on the floor, Tech Transfer, Tech Writing, Raw Material, Biotech, Pharmaceutical, Laboratory

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