Position Summary: The Document Control Specialist will be responsible for the maintenance and management of controlled documents and records for Precision for Medicine as well as provide administrative support to the quality assurance team.
Essential functions of the job include but are not limited to:
- Quality Assurance, Document Control - General
- Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc.
- Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organization
- Ensure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise, spelling) and compliance with internal and external standards.
- This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documents
- Assist with Quality Systems Improvement such as harmonization of the Global Quality Management System, process improvements, and other system changes as needed.
- Assign training workflows for new or revised quality system procedures and for new employees
- Maintain document security. Coordinate Periodic Review of Documents to owners.
Training
- Conduct training for new and existing employees on electronic quality management system as needed.
Audits
- Assist during audits as needed.
- Pulling employee Dossiers or physical training records.
- Answer any questions related to the Quality Management System (QMS)
- Pull archived documentation and archived controlled documentation from the Quality Management System (QMS).
Qualifications: Minimum Required:
- Bachelor’s degree
- 2-3 years of experience QMS Management, including document/record control.
- Working knowledge of quality and documents in a regulated environment.
Other Required:
- Ability to meet deadlines and perform administrative functions
- Microsoft Office suite proficiency
- Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs.
- Must be able to read, write, speak, fluently and comprehend the English language
Other duties
- Other duties as defined by management
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
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What We Do
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
