QA Analyst; Biotech

Piper Companies

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.

• 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 initiatives.

• 1+ years of QA experience working in biotech, pharmaceutical, cell therapy or other GMP-regulated environment.
• Experience with document control systems (Veeva, Master Control, Track Wise, EDMS, eQMS, etc.).
• Strong GMP knowledge.
• Experience with CAPA deviations, batch record review/approval and assisting in document lifecycle responsibilities.
• Background in root cause analysis, CAPA generation, and QMS process improvements.
• Bachelor’s degree in Biology, Biotechnology, Life Sciences, Chemistry, Engineering, or related discipline.

• 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.