Document Control Specialist II
- Phoenix, AZ
Summary of Major Responsibilities
The Document Control Specialist II position maintains and manages all data and documents primarily associated with a “test” for the Exact Sciences Laboratories. This position will hold System Administrator rights and can assign duties to other Document Control Specialists for tasks required to maintain the system. This position is responsible for overseeing the update, review, release, and storage of documents. Documents may include (but are not limited to) policies, standard operating procedures (SOPs), forms, job aids, validation materials, training records and other documents or records. Additionally, the position oversees supplier audits, IT audits and any other audits required by applicable state or federal regulations. The position works closely with all departments at Exact Sciences Laboratories.
Essential Duties and Responsibilities
- Hold System Administrator rights and can assign duties to other Document Control Specialists for tasks required to maintain the system.
- Coordinate upgrades of the document control system, and coordinate trainings and communications related to upgrades or system notices as needed.
- Maintain the official procedure manual and the associated procedures, forms, and supporting documentation.
- Perform change control activities, as requested, by Medical Director, Technical or Non-Technical Laboratory Managers, Supervisors, or other document authors.
- Maintain all paper and electronic files so that they are well organized, and information is easily retrieved.
- Work with all departments to identify and develop their document control needs and provide training, as needed, on the document control process.
- Follow the process for document control; including document creation, revision and retirement, and promotes use of current revisions.
- Provide guidance on consistency across controlled documents.
- Ensure that all references are listed within controlled documents are accurate and current.
- Ensure periodic document review on a biannual basis, when significant changes occur or when requested by the Medical Director, or as otherwise specified.
- Ensure that the Medical Director and/or NY COQ completes annual review of all SOPs and that all signatures are documented.
- Ensure that the test validation and instrument validation documentation is current and linked to the procedure.
- Ensure that all chart reviews are current and all associated documentation files are updated.
- Ability to maintain confidential information.
- Excellent verbal and written communication skills.
- Excellent attention to detail and organizational skills.
- Ability to interface, work effectively, and conduct themselves in a professional manner with all levels of the organization, vendors, customers, etc.
- Ability to effectively manage multiple projects simultaneously within defined timelines and prioritize when necessary.
- Ability to work in a team environment and adapt to changing workload and circumstances effectively; able to respond to new information quickly.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work overtime as needed.
- Ability to lift up to 40 pounds for approximately 25% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
- High School Diploma or General Education Degree (GED).
- 3+ years of professional work experience.
- 6+ months of experience in applicable document control system with proven proficiency.
- Basic computer skills to include Internet navigation, Email usage, and word processing.
- Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- Some college coursework.
- Coursework in technical writing, or previous technical writing experience.
- Previous experience in a clinical laboratory setting.
- Specific training or certification in the advanced use of Microsoft Office products.
We are 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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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