Piper Companies is seeking a detail-oriented Quality Document Control Analyst to join our dynamic team in a fast-paced biopharmaceutical environment out of Gaithersburg, MD. This role is critical to ensuring compliance with regulatory standards by managing controlled documents, supporting audits, and driving continuous improvement in documentation practices.

QUALIFICATIONS OF THE QA DOCUMENT CONTROL ANALYST:

• 1+ years of experience in document control and/or Quality Assurance (QA) within a GMP-regulated biopharmaceutical or biotechnology environment
• Strong understanding of cGMP, GDP and regulatory compliance requirements
• Experience with batch records, controlled documents, audit reporting and quality documentation practices
• Proficiency in document management systems, QMS, Microsoft Office Suite
• Excellent attention to detail, organizational and ability to manage multiple priorities
• Very strong communication skills
• Bachelor’s degree in science related field (Biology, Biotechnology, Biological Sciences, Chemistry, Molecular & Cell Biology, etc.)

• Manage the lifecycle of controlled documents including SOPs, batch records, protocols, and training materials
• Review, revise, and format documents to ensure alignment with regulatory and internal standards
• Support deviation investigations and CAPA documentation by compiling evidence and tracking corrective actions
• Maintain document control systems and ensure accurate indexing, versioning, and archival of records
• Assist in preparation for internal and external audits by ensuring documentation readiness and compliance