Document Control Specialist II/III (ADX-225-19)
Document Control Specialist II/III ADX-225-19)
ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.
Make it happen by joining us in the fight against cancer.
POSITION SUMMARY:
The Document Control Specialist collects, maintains and distributes all documents necessary to define product configuration and control manufacturing processes that insure conformance to customer requirements in both the GMP and non-GMP space. Using Quality Management System software (eQMS) the specialist develops and maintains a comprehensive filing system and computer database for all documents. The specialist manages documents via the eQMS to ensure that all users have the latest revision of appropriate documentation in a timely manner. The Document Control Specialist reports to the QMS Manager.
RESPONSIBILITIES:
- Processing documents in the document control module in the eQMS system
- Assist all the functional departments that submit documents to ensure the accuracy and timely release of their documents
- Collect and maintain files of the latest revision level documentation necessary to define product configuration and control manufacturing processes
- Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from the distribution
- Maintain a computer database of all filed documentation that ensures fast retrieval of documents
- Manage the document archiving process
- Assist with the scanning of all documents under the QMS
- Generate documents for various departments
- Provide training on the document management process
- Maintain the quality indexes associated with the monitoring of the document control process
- Maintain compliance with all company policies, quality systems, and procedures
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
QUALIFICATIONS:
- Attention to detail with an ability to follow directions in modifying the documentation
- Ability to interact with multiple disciplines; communicate clearly and effectively verbally and in writing
- Ability to work with minimal direction, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
EXPERIENCE:
- High School Diploma required
- 5+ years of Document Control experience with at least 3 in an FDA-regulated environment (Level III)
- 3-5 years Document Control experience with at least 2 in FDA-regulated environment (Level II)
- Experience with QMS software