Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

Encoded is seeking a Specialist II, Quality Assurance that will serve to provide Quality Assurance support for early-stage gene therapy candidates. As part of the Quality Assurance group primarily responsible with providing quality oversight and support to operations at Encoded in support of manufacturing operations.

Workplace Model: Hybrid (Note: Support for manufacturing operations may require shift coverage consisting of weekdays or weekends at times.)

Responsibilities

• Provide on-the-floor QA oversight and support to manufacturing operations.
• Review and approve master batch records, labels, specifications and other documents for intermediates, drug substance, drug product, and packaging and labeling.
• Review executed batch records and associated documents to ensure compliance with approved procedures and CGMP expectations to determine acceptability of product disposition.
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including packaging and shipment.
• Provide quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Supports, reviews and approves change control assessments, implementation and closure.
• Accountable and responsible for archival of batch records and other supporting documents.
• Represents QA in cross-functional team meetings and interacts with Manufacturing, MSAT, Facilities & Engineering, Supply Chain, QC, Regulatory, etc. applying strong communication and collaboration skills.
• Author and revise QA related standard operating procedures and provides guidance for generation, review, and approval of process, equipment, test method, and other SOPs.
• Trend and report key metrics for quality system monitoring.
• Assist with internal and external audits, as required.
• Manage and maintain QA logs, logbooks, databases, etc.
• Maintain equipment files, approves IQ/OQ/PQ protocol and reports, and ensures all applicable documentation is archived.
• Able to manage quality related issues with minimal supervision.
• Assist in the development, implementation, and continuous improvement of various quality systems, policies, and procedures.
• Assist with internal and external audits, as required.
• Perform other duties and projects as assigned by management