Qa Associate Jobs

At TCR² Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage cell therapy company pioneering the development of novel T cell therapies by utilizing our TRuC platform. Our lead autologous cell product gavo-cel (TC-210) is being studied in a Phase 1/2 trial for treatment refractory mesothelin-expressing solid tumors. In addition, our emerging and dynamic oncology pipeline focuses on a series of next-generation enhancements, novel targets and an allogeneic platform which may further improve clinical outcomes and broaden patient access.

This role is based in Cambridge, Massachusetts, with flexibility for hybrid work.

We are looking to expand our quality organization with a Quality Assurance (QA) Associate to join the TCR2 Quality Systems and Engineering team. As a QA Associate, your role will be critical to maintaining the compliant state of controlled documents, records, personnel training, as well as the release of clinical batches to patients. In addition, the individual may participate in more complex projects, operational excellence initiatives, and quality systems with supervision.

Responsibilities:

• Perform routing, review, and approval activities in Part 11 compliant electronic system
• Responsible for ensuring that GMP records are maintained, secure, and retrievable throughout defined record retention periods
• Maintain personnel files of new, incumbent and previous personnel
• Track training progress and completion to ensure quality metrics are met or exceeded
• Issue and maintain training of new and incumbent personnel
• Identify deviations and escalate to quality issues to management
• Performs other Quality duties and tasks as required
• Support supplier quality management activities, as needed
• Participate in the creation and/or review of controlled documents
• Perform a thorough review, formatting and processing of all SOPs, ROPs, Policies, protocols, reports, and records for adherence to formatting and content requirements
• Managing ongoing creation and maintenance of Training Plans and training materials
• Maintain the electronic and physical archival of records and assure documents per GMP requirement to ensure documents are readily available to authorized personnel
• Conduct a thorough and complete review of batch records to meet team deadlines in support of product disposition for clinical use

Requirements:

• Bachelor’s degree required or 2-4 relevant work experience in a GMP regulated industry
• Ability and desire to learn new skills and computer systems
• Ability to work in a fast-paced environment with multiple priorities
• Proficient with Microsoft Suite (Word, Excel, PowerPoint)
• Detail-oriented with the ability to multitask to handle multiple projects
• Must be authorized to work in the U.S.
• Proven time management and organizational skills
• Excellent interpersonal and communication skills to work well in a team environment
• Forward thinking with a proactive approach; thinking outside the box for creative solutions

Preferred Experience

• Experience with an LMS
• Experience with an EDMS
• Experience performing batch record reviews
• Experience with Veeva is highly desired