Document Control Specialist I
Summary of Major Responsibilities
The Document Control Specialist I position maintains and manages all data and documents primarily associated with a “test” for the Exact Sciences Laboratory. This position is responsible for the update, review, release, and storage of documents. Documents may include policies, standard operating procedures (SOPs), forms, job aides’ validation forms, supply instruction audits, IT audits and any other audits required by any applicable state or federal regulations. This position will also perform general administrative assistance functions to support the staff and visitors to the Exact Sciences Laboratory. This position may also receive direction and work assignments from designated individuals other than the positions listed above. Works closely with the Quality Systems Specialists and Document Control Analysts at Exact Sciences Corporation.
Essential Duties and Responsibilities
- Maintains the official procedure manual and the associated procedures, forms, and supporting documentation through use of Word.
- Enters changes in the system as requested by Medical Director, Technical or Non-Technical Laboratory Managers, Supervisors, or other SOP authors.
- Maintains all paper and electronic files such that they are well organized and information is easily retrieved.
- Provides training as needed in the use of Word for other document authors or approvers. .
- Follows the process for approval of SOPs and revisions.
- Controls forms associated with all SOPs.
- Controls the USB drives used for SOP backup.
- Ensures that all forms in use in departments are the current, updated version.
- Ensures that all references in SOPs are accurate and current.
- Ensures that all SOPs are reviewed on a biannual basis, when significant changes occur or when requested by the Medical Director.
- Ensures that the Medical Director and/or NY Cof Q completes annual review of all SOPs and that all signatures are documented.
- Ensures that the test validation documentation is current, linked to the procedure and available in Word.
- Ensures that all instrumentation validation documentation is current, linked to the procedure and available in Word.
- Ensures that all chart reviews are current and all associated documentation files are updated.
- Responsible for the annual reagent label audits. Ensures appropriate compliance language for labeling of laboratory reagents.
- Management retains the discretion to add to or change duties at any time.
- Provide administrative and clerical support for the leadership team, and other members of the facility as needed. May handle details of a highly confidential and critical nature.
- Receive incoming calls, manage minor requests for information/assistance, and route other calls as appropriate.
- Schedule and coordinate meetings, may prepare agendas, reserve rooms, and arrange for catering food services.
- Draft correspondence and presentations, types from notes, edits, photocopies, faxes, files, etc. which may be of a confidential nature. May prepare presentation materials for meetings.
Mandatory Skills & Qualifications:
- Must be proficient in using basic software applications including Microsoft Office.
- Demonstrated ability to maintain confidential information.
- Excellent verbal and written communication skills.
- Ability to interface and work effectively with all levels of the organization, vendors, customers, etc.
- Ability to effectively manage multiple projects simultaneously within defined timelines and prioritize when necessary.
- Excellent attention to detail and organizational skills.
- Ability to work in a team environment and adapt to changing workload and circumstances effectively; able to respond to new information quickly.
- Professionalism: conducts themselves in a professional manner in all interactions with members of the Exact Sciences Clinical Laboratory team, clients and associates.
Necessary Education & Experience:
- High School Diploma or GED required.
- At least 3 years of professional work experience.
- Some college coursework preferred.
- Coursework in technical writing, or previous technical writing experience preferred.
- Previous experience in a clinical laboratory setting preferred.
- Specific training or certification in the advanced use of Microsoft Office products preferred.
Physical Requirements & Working Conditions:
- Ability to listen and speak on the telephone and write simultaneously.
- Ability to operate telephone system and computer keyboard and printer.
- Ability to lift and move 20-40 pounds on an occasional basis (up to 25% of time).
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email [email protected].
Meet Some of Exact Sciences's Employees
As a research scientist on the Product Development Team, Brenda’s core responsibilities revolve around new pipeline projects and process improvements to Exact Sciences’ Cologuard tests.
Back to top