Posted in Other 30+ days ago.
Type: Full Time
Rebiotix Inc, part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on HARNESSING THE POWER OF THE HUMAN MICROBIOME to revolutionize the treatment of debilitating diseases. Located in Roseville, Minnesota, our goal is to IMPROVE THE LIVES OF PATIENTS and reduce the cost of care associated with complex diseases through our INNOVATIVE MICROBIOTA-BASED MRT DRUG PLATFORM. We are a passionate team of scientists, engineers, and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for today s medical needs. We are looking for like-minded get-it-done individuals to add to our growing team.
The Document Control Coordinator is responsible for supporting the control of master records (document control), change management process, and the Training Program.
Support Control of Documents and Records by ensuring their accuracy, quality and integrity.
* Create, maintain and control the master documentation files.
* Document Updating, formatting, printing for signatures and issuance of documents.
* Scan, image, organize file and retrieve documents; physical and electronic.
* Distribute/reconcile controlled copies of documents.
* Maintain final word versions for revision purposes to maintain the integrity of the document.
* Support organization and storage solutions.
* Administer periodic review and record retention.
* Review of documentation prior to issuance to ensure compliance with site SOPs.
* Responsible for distribution/notification of document releases, changes and obsolescence
* Assist in the creation and updating of Standard Operating Procedures and forms specific to the document control processes.
SUPPORT CHANGE MANAGEMENT SYSTEMS
* Issue change numbers, update electronic logs, route documents for review/approval, schedule change control meetings as required.
* Review change control for accuracy, and completeness to site SOPs.
* Monitor and promote change controls throughout the process.
* Effectively communicate with others to coordinate implementation of change, as required.
SUPPORT TRAINING PROGRAM
* Enter employee training, identify overdue training, implement training profile updates, schedule training as required, file physical training records.
* Monitor the status of employee training and manage implementation of controlled documents when requirements are met.
Support metrics, as required * Create, modify, and report on metrics
* High school diploma with a minimum of three (3) years document control or QA experience within a FDA regulated industry required or Bachelor s degree with a minimum of one (1) or more years document control or QA experience within a FDA regulated industry required.
* Must possess a high level of attention to detail and proficient in Word and Excel. Strong computer, organizational, and compliance skills. Individual must be adept at working with computer data systems, enter data accurately and consistently and must be able to search databases for retrieval of information.
* Familiarity with master document management, change control process, and FDA quality system regulations is desired.
* Ability to work effectively on multiple projects simultaneously with minimum supervision.
* Must be able to reach down and up in order to place documents on shelves. Ability to lift 40-50 pounds when needed.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected
Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.