Specialist II, Quality Assurance

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

Requirements

• Bachelor’s Degree in relevant disciplines in life sciences.

• 3+ years of QA experience in a pharmaceutical or therapeutic environment.
• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).

• Ability to thrive in a fast-paced dynamic environment with the ability to maintain objective and autonomous as it relates to quality and compliance.

• Demonstrated knowledge of quality management systems, processes, and procedures.
• Knowledge of six sigma, LEAN and root cause analysis tools for identifying and correcting deviations
• Strong interpersonal and communications skills; written and oral.
• Outstanding planning, organization and multitasking skills.
• Must be a team player and exhibit a willingness to meet project timelines.
• Extremely high degree of attention to detail.
• Strong documentation skills.

• Responsible and accountable with non-compromising high ethical standards.
• Prior gene therapy experience is a plus

The anticipated salary range for candidates who will work in North Carolina is $72,250 - $97,750. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Encod