Document Control Specialist

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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