Quality Assurance Documentation Specialist (CONTRACT)

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Adicet Bio, Inc is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CAR) and T cell receptor-like antibodies (TCRL), to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. For more information, please visit our website at http://www.adicetbio.com.

QUALITY ASSURANCE DOCUMENTATION SPECIALIST (CONTRACT)

The QA Documentation Specialist is responsible for daily support of the GMP (Good Manufacturing Practice) Document Management System in support of cell therapeutic products development from early phases to commercialization. You will be responsible for assisting with the maintenance of document/record life cycle management within the document control department, in a compliant and secure manner per cGMP regulatory requirements and Adicet Quality Manual. In addition, you will be responsible for assisting with the Adicet training program.

This position will report to the Director, Quality Assurance and will have no direct reports.

Key responsibilities:

1. Supporting the GMP Document Control department in support of cell therapy drug development.
2. Write or revise procedures covering Document Control and/or Training processes.
3. Support the life-cycle of documents (creation, distribution, revision, review cycle, implementation) including periodic review cycles.
4. Issue document numbers/templates, reconcile, scan, file, and archive technical protocols/reports, validation protocols/reports.
5. Maintain information accurately following GDP (Good Documentation Practice) to support operations and overall life cycle of documents and records.
6. Review documents to ensure adherence to formatting requirements and the respective effective document template.
7. Supporting distributed documents and ensuring documents are the current version; ensure the integrity and consistency of the distributed documents.
8. Support daily use and check-in (reconciliation) of documents issued to their department.
9. Support the Document Change Control process: GMP document initiation, revision and retirement. Ensure changes to the GMP documents are linked to our training program.
10. Control of GMP Documents
11. Ensure paper GMP documents and records are retained in a secure location with consideration given to the prevention of fire and water damage as well as loss prevention.
12. Follow Adicet procedures for issuance, receipt, reconciliation, scanning, filing, and archival of executed.
13. Assure only the current, effective version of a GMP document is issued when requested.
14. GMP Document Archiving and Retention
15. Support all GMP document periods of retention, including on-site storage: the documents may be in the form of original paper records, logbooks, electronic records, and or authenticated copies obtained by photocopy, photography, electronic scanning or other suitable means.
16. Support the site’s retention schedule and archival process to ensure documents are appropriately retained & retrievable.
17. Assist with maintenance of the Adicet Training Program
18. Update training items, training matrices/curricula and training assessments as needed.
19. Support the maintenance of the following training functional parts: training materials, training methods, training matrices, trainer qualification, training plan, training records and training evaluation.
20. Work with SMEs in developing & updating On the Job Training (OJT) and in maintaining the Training Effectiveness program.
21. Assist with the process of filing and retrieval of completed Training Records.
22. Work with departments to ensure training curricula are appropriately updated per changed GMP documents.
23. Assists in the development, presentation and maintenance of training content, training curricula and metrics in compliance with policies, procedures, and applicable regulations.

Desired Qualifications:

• High School diploma required.
• Bachelor of Science degree preferred.
• 4+ yrs experience working in a regulated environment using a GMP document management system and maintaining the document lifecycle.
• Experience in the following areas: Quality Assurance, Change Control, Document Control, or Training Systems.
• Experience working with electronic Quality Management Systems such as TrackWise, MasterControl, Documentum, ComplianceWire or others similar is required.
• Strong skills with Microsoft Suite such as Microsoft Word, Excel and PowerPoint.
• Knowledge of GMP, ICH, USP, EP, and CFR requirements and regulations.
• Comfortable working in startup environments and communicating cross-functionally across the organizational site and possible other global positions.
• Ability to communicate clearly and in an engaging manner with colleagues of various levels of experience and management.
• Experience working with a multi-user/department training program is preferred.
• Experience of internal and external audit is a plus.

Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.