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Piper Companies

QA Document Control Analyst

Piper Companies, Gaithersburg, Maryland, us, 20883

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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.Responsibilities of the QA Document Control Analyst:•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 complianceQualifications 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.)Compensation for the QA Document Control Analyst includes:•Salary: $50,000 - 65,000 annually, commensurate with experience•Comprehensive Benefits: Medical, Dental, Vision, 401k, Sick leave as required by law, PTO (Paid Time Off)This job opens for applications on 09/05/2025. Applications for this job will be accepted for at least 30 days from the posting date.Keywords: QA, quality assurance, document control, document archival, archival, document control analyst, doc control, document control specialist, biotechnology, biopharmaceutical, pharmaceutical, cell therapy, document management system, DMS, QMS, quality management system, veeva, GMP, good manufacturing practice, GDP, good document practice, batch record, audit, regulatory audit, regulatory, regulatory compliance, cGMP, current good manufacturing practice, manufacturing associate, upstream, downstream, all stream, controlled documents, SOP, standard operating procedure, laboratory, indexing, CAPA, CAPA documentation, CAPA investigations, deviations #LI-BN1 #LI-ONSITE