Specialist II, Quality Assurance
Encoded Therapeutics
This job is no longer accepting applications
See open jobs at Encoded Therapeutics.See open jobs similar to "Specialist II, Quality Assurance" Venrock.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
This job is no longer accepting applications
See open jobs at Encoded Therapeutics.See open jobs similar to "Specialist II, Quality Assurance" Venrock.