resTORbio, Inc. (“resTORbio”), a subsidiary of PureTech Health, is a clinical stage company, developing medicines to treat aging-related diseases and conditions. resTORbio’s lead program is targeting the mechanistic target of rapamycin complex 1 (mTORC1) pathway to treat aging-related diseases and conditions with an initial focus on conditions caused by immunosenescence, the decline in immune function due to aging. resTORbio lead product, RTB101, entered Phase IIb for the first indication targeted by the program, reducing the incidence of respiratory tract infections (RTI) in elderly subjects at increased risk of RTI-related morbidity and mortality. resTORbio’s lead program is built upon two Phase 2 clinical studies demonstrating promising safety and efficacy results in almost 500 hundred elderly subjects. resTORbio is pursuing a pragmatic clinical development plan addressing areas of key unmet medical need in the aging population. For more information, visit www.resTORbio.com or connect with us on Twitter @resTORbio_Inc.
The document control specialist will develop, establish and maintain document control methodologies, systems, and practices which meet the applicable regulatory requirements and resTORbio procedures. He or she will serve as a quality representative to improve Document Control and Good Documentation Practices awareness of the regulatory and resTORbio requirements to the different functional areas. He or She will communicate quality initiatives in support of departmental and functional quality goals and priorities. You will provide Document Control support to the Quality team and documentation support to other teams, as needed. This is a hands-on, non-supervisory position.
- Champions Document Control initiatives at resTORbio Quality (GLP, GMP, GCP).
- Prepares appropriate documentation and executes the release of acceptable product lots and vendor materials.
- Reviews completed manufacturing, filling, packaging and labeling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Authors, revises, reviews, and formats resTORbio documentation in compliance with company procedures and the applicable regulatory requirements and standards.
- Manages and maintains the Document Control system at resTORbio including but not limited to the organization, issuance, maintenance, archiving and retirement of documents.
- Maintains internal and external libraries at resTORbio documentation and is the primary liaison with external libraries subcontractors.
- Ensures that all documentation is controlled and current.
- Generates applicable training materials on Document Controls and Good Documentation Practices as needed and as defined in the resTORbio procedures. Conducts related training on a periodic basis and as needed.
- Provides guidance and support to teams in generating applicable documentation.
- Proactively investigates document control issues, identifies improvements and implements good documentation practices at resTORbio.
- Ensures that all Document Control requirements are met at all stages of the product development process and manufacturing.
- Manages Employee Training documentation including the maintenance of employee training records.
- Where applicable, ensures that all Laboratory Notebooks are controlled, maintained, stored and archived.
- Orders, issues and maintains all applicable Logbooks
- Works as part of a team with an emphasis on continual improvement of processes, quality management systems, and compliance.
- Ensures that all company records are maintained, stored and archived according to company procedures and the applicable regulatory requirements and standards.
- Associate Degree required -- Bachelor Degree preferred.
- 2-5+ years of quality/document control experience in the pharmaceutical industry or biotech industry.
- Working knowledge of compliance best practices for biologics or drug products. Ability to prioritize, manage time well, multitask, troubleshoot.
- The position requires good communication skills, organization and an eye for detail.
- Comprehensive knowledge of US Quality System Regulatory requirements.
- Demonstrated success in delivery of key milestones against tight timelines.
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
- Aptitude to succeed in the culture of a fast-paced, start-up biotechnology company.
- Strong written and verbal communication skills. Technical writing skills preferred.
- Must be able to work in a team environment and with some to minimal supervision.
- Strong organizational and computer (Microsoft Word, Excel, PowerPoint, Adobe Acrobat) skills required.