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 duties 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) and compliance with internal 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 Procedure revision as part of an integration process: keeping track of originating procedures and the new / integrated procedures as well as all related documents (manuals, forms, flowcharts)
- Assign training workflows for new or revised quality system procedures and for new employees
- Maintain document security
- Coordinate Periodic Review of Documents to owners
- Upload existing/new revision documents to the PLN portal or Precision PLN sites
Training
- Conduct training for new and existing employees on electronic quality management system.
Audits
- Locate, review, submit, and reconcile document/record requests during audits
- Ensure timely response to documentation requests for audits
- Prepare welcome packet folders for upcoming audits
- Update procedure binders for upcoming audits
- Prepare Dossiers on Employees Training Binders that are selected
Other duties
- Other duties as defined by management
Qualifications:
Minimum Required:
- Bachelor’s degree
- 1-3 years of experience with ISO 9001/13485 standards
- Working knowledge of quality and documents in a clinical research organization
Other Required:
- Obtain Document Control certification within first year
- 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
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
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. © 2020 Precision Medicine Group, LLC
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.
Top Skills
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.
