Piper Companies is currently seeking a Document Control Specialist for an opportunity in Branchburg, New Jersey (NJ), to join an innovative biotechnology company creating life-saving cell therapies.
Responsibilities of the Document Control Specialist
- Interface with internal and external team members to provide Quality Assurance support and ensure compliance with cGMP regulations and company SOPs
- Independently prioritize, schedule, and manage workload to meet departmental needs effectively
- Store, manage, and track company documents using document control software and filing systems, and assist in implementing and validating the electronic Quality Management System
- Issue and track controlled documents such as Batch Records, NOEs, Deviations, and CAPAs
- Review SOPs, Work Instructions, and controlled documents for adherence to approved templates prior to approval
Qualifications of the Document Control Specialist
- 5+ years of Quality Assurance experience in cGMP life sciences company, with early phase biologics or cell therapy experience preferred
- Experience in revising and reviewing, cGMP related documents including SOPs, Batch Records, Validation / Qualification Reports, Technical Reports, etc.
- Strong working knowledge of current ICH / CFR / GMP regulations and practices, QMS (Quality Management Systems) focusing on Document Control and Training
- Experience in document and data review, investigations / deviations, and material traceability and tracking
- Experience with electronic system implementation and validation a plus
- Bachelor’s degree in Biology, Chemistry, or related discipline
Compensation for the Document Control Specialist
- Salary Range : $35.00 - $45.00 / hour
- Benefits : Medical, Dental, Vision, 401k match, Paid Holidays, and PTO
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Document Control Specialist
QA, quality assurance, biotech, biotechnology, cell therapy, cell therapies, QMS, quality management system, document management, training, trainer, training system, batch record, batch records, document review, lifecycle documents, deliverables, quality management, Phase I, Phase One, Phase 1, Phas...
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