QA/RA Document Control Specialist
Founded in 2015, Frequency Therapeutics is a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases. Our approach, called Progenitor Cell Activation (PCA), uses combinations of small molecule drugs to activate progenitor cells within the body to create functional tissue. Frequency’s lead program, FX-322, is a potential first-in-class therapeutic candidate targeting hearing restoration. Other potential applications of our PCA platform include, but are not limited to, diseases of the CNS, muscle, gastrointestinal tract, skin, and bone. Frequency currently has a strategic development and commercialization agreement with Astellas Pharma, Inc. for the development of FX-322. To date, the Company has closed three rounds of funding, raising nearly $150 million.
The QA/RA Document Control Specialist reports to the Vice President of Regulatory Affairs and is responsible for the timely publishing and implementation of SOPs and regulatory submission documents. Responsibilities include archiving documents from regulatory, quality, manufacturing, preclinical and clinical functions, and technical support to QA/RA functions.
Key Responsibilities Include:
Implement and maintain eDMS system as SME for publication and storage of quality and regulatory documents including template development and maintenance
Provide publishing, editing and formatting support for quality and regulatory documents, including preclinical and clinical documents in eCTD format, standard operating procedures, and ancillary reports, validation documents and methods
Support quality and regulatory document preparation, coordination of multidisciplinary reviews, and maintenance of logs, planners and libraries (e.g. scan, print, file)
Maintain knowledge of and trends in health authority procedures and guidance documents regarding electronic submissions
Coordinate with QA/RA lead and functional leads to coordinate writing, review and publication across functions
Provide additional administrative and planning support as needed.
A fundamental belief held by the Frequency Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large. Please visit www.frequencytx.com for more information.
We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology. For consideration, please submit cover letter and CV.
- BS Degree in Life/Health/Technical Sciences desired or equivalent experience in document control and/or combination of experience and training
- 3 or more years’ experience in medical device or drug quality systems and regulatory submissions required
- Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher) and document publishing tools
- Proficient experience with electronic document management systems such as Master Control
- Strong software troubleshooting skills highly desirable
- Ability to work both independently with minimal direction, and within project teams, to meet group goals
- Professional communicator with the ability to interact effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Exceptional organizational skills with the ability to prioritize deadlines, maintain focus and monitor progress on assigned tasks, while working independently.
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QA/RA Document Control Specialist