Document Controller

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Position Overview

The Document Controller (DC) position supports the maintenance and management of all records and documents for the Laboratories of Exact Sciences. This position is responsible for the update, review, release, and storage of documents. Documents may include, but are not limited to, policies, standard operating procedures (SOPs), forms, work instructions, validation materials, training records, and other documents or records. Additionally, the DC will assist with supplier audits, IT audits, and any other audits or inspections required by applicable state or federal regulations. The DC position works closely with all departmental leadership at Exact Sciences Laboratories.

This is a hybrid position with three in-office days each week.

Location: 1 Exact Ln, Madison WI

Essential Duties

Include, but are not limited to, the following:

• Support in maintaining the integrity and functionality of the document and record control program at the Laboratories of Exact Sciences.
• Follows and supports the process for document control, including document creation, revision, and retirement, promoting the use of current revisions.
• Assists all departments with their document and record control needs and provides training, as needed, on the document control process.
• Maintains all paper and electronic files such that they are well organized, information is easily retrieved, and records are maintained according to the record retention schedule.
• Manage the document request program by controlling permissions and initiate training when necessary.
• Maintains all controlled copies of documents and works with the Laboratories to provide all paper copies of documents.
• Assists with audits of the document control system at minimum annually.
• Assists with periodic document review on a biennial basis, when significant changes occur, when requested by the Medical Director, or as otherwise specified.
• Assists the Clinical Lab Quality and Regulatory department to ensure the Director and/or individual(s) holding a New York COQ completes designated review of all SOPs, and that all signatures are documented.
• Ensures that the test and instrument validation documentation is current, linked to the procedure, and available.
• Excellent verbal and written communication skills with the ability to maintain confidential information.
• Ability to interface, work effectively, and conduct themselves in a professional manner with all levels of the organization, vendors, customers, etc.
• Ability to effectively assist with projects within defined timelines.
• Meticulous with excellent organizational skills; ability to respond to new information quickly.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Supports and complies with the company's Quality Management System policies and procedures.
• Regular and reliable attendance, with ability and means to travel between office locations.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule and work overtime, nights and/or weekends as needed.
• 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.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height; lift up to 40 pounds on occasion.

Minimum Qualifications

• Bachelor's degree in a Library Science, Communications, Business Administration or related field; or high school degree/general education diploma and 4+ years of relevant experience in lieu of Bachelor's degree.
• 2+ years of relevant work experience.
• 1+ years of experience in a regulated environment.
• Demonstrated ability to collaborate across functions and with both internal and external stakeholders, and to communicate ideas and opinions in a proactive and professional manner.
• Proficient in basic software applications including Microsoft Office and Adobe.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 1+ years in a Document Control position or coursework in document control.
• 1+ years of experience with audits or inspections by regulatory bodies, such as CAP, NY, or FDA.
• Specific training or certification in the advanced use of Microsoft Office products.
• Experience with HIPAA regulations.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.