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Qa Associate Jobs
Company | TCR² Therapeutics Inc. |
Address | Cambridge, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet Publishing |
Expires | 2023-05-10 |
Posted at | 1 year ago |
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.
- Identify deviations and escalate to quality issues to management
- Conduct a thorough and complete review of batch records to meet team deadlines in support of product disposition for clinical use
- Perform a thorough review, formatting and processing of all SOPs, ROPs, Policies, protocols, reports, and records for adherence to formatting and content requirements
- Support supplier quality management activities, as needed
- Managing ongoing creation and maintenance of Training Plans and training materials
- Perform routing, review, and approval activities in Part 11 compliant electronic system
- Track training progress and completion to ensure quality metrics are met or exceeded
- Issue and maintain training of new and incumbent personnel
- Performs other Quality duties and tasks as required
- Maintain personnel files of new, incumbent and previous personnel
- Maintain the electronic and physical archival of records and assure documents per GMP requirement to ensure documents are readily available to authorized personnel
- Responsible for ensuring that GMP records are maintained, secure, and retrievable throughout defined record retention periods
- Participate in the creation and/or review of controlled documents
- Proven time management and organizational skills
- Forward thinking with a proactive approach; thinking outside the box for creative solutions
- Proficient with Microsoft Suite (Word, Excel, PowerPoint)
- 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
- Detail-oriented with the ability to multitask to handle multiple projects
- Ability to work in a fast-paced environment with multiple priorities
- Excellent interpersonal and communication skills to work well in a team environment
- Must be authorized to work in the U.S.
- Experience with Veeva is highly desired
- Experience performing batch record reviews
- Experience with an LMS
- Experience with an EDMS
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