Quality Assurance Associate

Job Description

Job Description

Company

Elusys Therapeutics is dedicated to delivering innovative medical countermeasures that enable fast, effective, and durable protection against infectious agents. Our goal is to accelerate the development and commercialization of novel biodefense solutions, such as our anthrax antitoxin ANTHIM® (obiltoxaximab), for strategic government partners.

Position Summary

The Quality Assurance Associate will report directly to the Associate Director of Quality and be responsible for supporting quality activities required for the commercialization and delivery of Elusys products. This individual is a key member of the operations team providing quality oversight for outsourced cGMP operations for the manufacture of drug substance and product. Responsibilities include but are not limited to supporting manufacturing and analytical teams, quality assurance of analytical testing, cGMP compliance of biologics manufacturing and product handling, shipping, and record keeping activities.. The high performing professional will be a quick learner, flexible at executing across functional areas on tight timelines and will have a successful track record of creative problem-solving, effective communication, and strong leadership within complex environments.

Key Responsibilities

• Review and approve analytical data packages for accuracy, completeness, and compliance with GMP and internal SOPs.
• Support analytical method validation, qualification, and transfer activities by providing QA oversight and review of protocols, reports, and deviations.
• Participate in the review and approval of test results for in-process, release, and stability testing.
• Coordinate and schedule shipments for Elusys’s Bulk Drug Substance, Final Drug Product, and Samples (In-process, Release, and Stability) between CMOs and analytical vendors.
• Conduct reviews of executed batch records and ancillary documentation for accuracy, completeness, and compliance with approved procedures.
• Review all investigations, quality events (i.e., deviations, laboratory investigations, OOS, etc.), change controls associated with the release of the product.
• Tracking / Trending deviations and escalating patterns to improve quality.
• Contribute to the implementation of processes and procedures, including developing and authoring internal company SOPs.
• Liaise and manage externally with CMOs, analytical vendors and consultants..
• Identify opportunities to improve internal processes and drive their implementation.
• Conducting and/or supporting routine vendor audits.
• Oversee company shared file index, supporting process compliance by each department.

Qualifications

• Bachelors degree in a relevant technical or scientific discipline preferred.

• 2-3 years of QA or QC experience in a GMP-regulated biotech, pharmaceutical, or analytical laboratory environment preferred, related experience considered.
• Experience with analytical methods (e.g., icIEF, CE-SDS, HPLC) instrumentation (e.g., ProteinSimple iCE3/Maurice, SciEx PA800, Agilent 1100/1200 HPLC,) and validated data systems (e.g., Chromeleon, SMP) strongly preferred.
• In-depth understanding of analytical method validation, stability testing, and data integrity.

• Excellent working knowledge of cGMP and GDP.
• Experience with Quality Systems (Documentation, Deviations, Change Controls, CAPAs, etc.)
• Experience conducting quality assurance reviews on analytical and/or manufacturing documentation.
• Team player with ability to influence project teams and external partners while maintaining positive working relationships.
• Strong attention to detail, organization, and documentation accuracy.
• Exceptional communication skills (verbal and written).
• Ability to work independently.

Physical & Travel Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Travel: up to 5%.