1. 60 King Street Work No. (978) 867 5706
Groveland MA 01834 Home No. (978) 314-2310
Carol Sylvester
Current Position
Document Control Supervisor/eDMS System Coordinator/Training Coordinator
Enzymatics a Qiagen Co. Beverly, MA
July 2014 to
Present
POSITION SUMMARY
Document Control Supervisor is responsible for managing the company’s Quality Systems documents
and records, insuring controlled access to quality management system documents and the proper
maintenance of all QMS records to comply with the ISO standard. Provides training for Enzymatics’
employees on writing SOPs and work instructions. Manages the document review process to insure the
proper use of effective documentation.
The eDMS System Coordinator is responsible for the implementation and management of the EtQ
eDMS application. Defines all work flows in support of electronic application. The eDMS Coordinator
will provide ongoing monitoring for system performance and engage with stakeholders as necessary to
resolve application related issues. This role will be responsible for setting up, monitoring and
maintaining scheduled jobs to support the application.
The Training Coordinator provides training to all personnel in the use of the electronic documentation
system and presents Good Documentation Practice’s training to all new employees as Training
Coordinator. The Training Coordinator is responsible for all updates to the training database with
employee training based on training records submitted to Document Control. Files and maintains the
training files and updates the Training Database accordingly. Sends out companywide training
notifications and monitors to ensure all training is completed in a timely manner.
RESPONSIBILITIES
 Assist with setup and installation of EtQ documentation application.
 Configures all existing documentation into standard template in preparation for import into the
eDMS application
 Imports all documentation into eDMS and defines work flows.
 Interacts with management and other departments on special projects such as Orientation and
ISO Training.
 Attends meetings as necessary assuring Quality guidelines are being met per ISO 13485
(current revision)
 Authors, reviews and/or approves SOPs, work instructions and forms
 Acts as change control agent for all documents
 Reports metrics pertaining to Quality Systems
 Participates during regulatory/customer audits
 Reviews and manages Quality System Records for conformance and compliance
 Controls filing, access, retrieval, and retention periods for records and documents.
 Maintains Quality System Living Documents and records such as training matrix and the DCR
log
 Maintains the Training Database accordingly
 Contact person for Iron Mountain. Coordinates pickup of documents/records for archival
storage.
 Additional duties as assigned.

2. KEY ATTRIBUTES
 Drive and Determination
 Good Organization Skills and detail oriented
 Positive external and internal relationship management skills
 Ability to participate with others as a member of the team to ensure that demanding and difficult
projects are handled smoothly and cooperatively to enhance success of project and maintain
strong relationships within all parts of company
 Proven ability to thrive in a start-up/chaotic/change oriented environment
 Self-Starter
 Driven to perform
 Self-directed: Needs little explicit direction and no hand-holding
 Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth
and success of company is achieved
 Excellent Training Skills and people skills
Lead, Records Management
Bristol-Myers Squibb Devens,MA
Jun. 2008-July 2014
In this position it is my responsibility to support the initiation, routing, distribution and archiving of
cGMP documentation and facilitate the compliance of site documentation. Provide support on the
document Change Control Function. Participate in documentation audits of site departmental
procedures. Serve as a subject matter expert for the electronic document management system and good
documentation practices cGDPs to internal and external clients. Function as system administrator for
the electronic document management system. Create and conduct user train sessions on the electronic
document management system and cGDP topics for site departments. Provide support during
Regulatory inspections and corporate audits.
RESPONSIBILITES
 32 years’ experience in regulated environment focused on product quality.
 Strong teamwork and communication skills with the ability to follow written and
verbal instructions.
 Knowledge of biotech bulk and finished product manufacturing, analytical testing.
 Excellent computer skills and knowledge of MS Office and Document
Management systems.
 Function as the Coordinator of the Corporate Policy and Directive site reviews and
Comply with all BMS polices and directives, cGxPs and site procedures.
 Revise Area procedures when necessary.
 Continue as Ergonomic Team Support for Records Mgmt Area.
 Maintain 100% compliance with training requirements and Performance
Connections.
 Provide Flexible/Off Hours support when needed.
 Continue role as Subject Matter Expert (SME) for all Document Control Archiving
(DCA) User Group Training Sessions and 1:1 Training Sessions as well as provide
improvements and updates to the Presentation as necessary.
 Support the Issuance of Records for Execution.
 Continue to work as a Team Player and comply as a Service Organization in RMS.
 Continue as Check Coordinator for the Safety Group for Devens Site.
 Support Regulatory inspections and corporate audits.

3.  Customer Service: Manages and facilitates customer request and provides
guidance on QRM Document standards and processes
 SOPs and Admin: Continuously monitor and trouble shoot functional area task
and offers suggestions for process improvements
 Document Processing: perform life cycle management of documents such as
initiation, document number issuance, approval, distribution etc. Formatting and
editing documents and follow up with authors and reviewers to resolve issues.
Endure document quality and efficacy of document process flow.
 Quality Records Management (QRM) Functional Training: Independently
monitors and identifies needed training per training curriculum. Support
department training needs by maintaining and conducting training sessions in
support of department needs and initiatives.
 Metric Tracking and Reporting: Compile and report on individual and system
performance metrics against documented timelines and quality standards. Reports
dept. metrics to dept. management.
 Process Monitoring: Continue to assess QRM compliance to cGMPs, corporate
policies and procedures. Make suggestions to modify systems as necessary to
comply
 Leadership: Offer guidance and support to less senior members of QRM.
Communicate issues/problems to management.
 Projects: Work closely with the QRM Project Team on project related tasks
 Good Organization Skills and detail oriented
 Positive external and internal relationship management skills
 Ability to participate with others as a member of the team to ensure that
demanding and difficult projects are handled smoothly and cooperatively to
enhance success of project and maintain strong relationships within all parts of
company
 Proven ability to thrive in a start-up/chaotic/change oriented environment
 Self-Starter
 Driven to perform
 Self-directed: Needs little explicit direction and no hand-holding
 Able to organize and prioritize a diverse set of responsibilities to ensure that focus
on growth and success of company is achieved
 Issuance/proofing of all manufacturing Batch Records for the
manufacturing/quality groups along with word processing and distribution of the
batch records per the Manufacturing schedules.
 Coordination of BAP product documents through the Eroom and word processors.
 Coordination of BAP Facilitated Reviews for all document requests.
EDUCATION/EXPERIENCE
 Graduate of Middlesex Community College / Associate Degree in
Business Computer Applications
 32 years of service at Bristol-Myers Squibb Corp.