Hologic Corporate Document Control Analyst in Marlborough, Massachusetts
Corporate Document Control Analyst (Job Number: 170952)
Responsible to review, route and approve company Quality System related documents to ensure these are managed according to all internal and external requirements as applicable. Facilitates and coordinates the interaction between multiple cross functional groups to ensure appropriate changes are documented. Provides Document Control Guidance, support, and troubleshooting to the user community as needed. Gathers data and generate document control related reports to provide visibility and signal to management on the document control process performance according to established goals and objectives. Manages and executes storage of quality system related documentation per established retention schedules.
Essential Duties & Responsibilities
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Reviews, routes and approves Quality system related documents according to established policies and procedures.
Effectively manage global projects assuring timely completion of all document control deliverables.
Communicate efficiently and effectively with project teams, management and various cross-functional contacts on documentation progress.
Manage the storage of quality system related documentation, as appropriate, per established schedules.
Interface with appropriate cross functional contacts - R&D, Manufacturing, Advanced Engineering, Marketing, Regulatory, Quality etc. - to expedite documents timely and support business needs.
Create and provide training on document control processes including Agile to all levels within the organization.
Develops and executes to key performance indicator metrics for documentation control and other Quality System elements including preparation and distribution of reports as needed.
Provides support and documentation to support internal and external audits.
Assists with providing resolution and/or addressing root cause of issues related to document control.
Works with outside vendors, as appropriate, to develop part and component documentation.
Manages Document Control projects and initiatives, as necessary.
Document Control subject matter expert and represents the documentation control department as required.
Provides input and support in the development and improvement of document control related procedures and work instructions.
Provides guidance to users to ensure compliance and accurate document generation and revision.
Develop custom dashboards in the PLM system that will be used for reporting, work lists and monitoring quality systems.
Ensures Quality System related documents are maintained in a secure and organized manner and ensures documentation is retrievable and accurate.
Monitors and tracks the review, approval, and distribution of documents to ensure timely completion to meet established timelines.
Resolves and provides guidance on complex Document Control issues.
- Bachelor’s Degree in Engineering, Technology, Document Management preferred or an equivalent combination of education and experience
3-5 years’ experience in document control in an FDA regulated environment
Understanding of documentation control regulations as well as ISO and FDA requirements
Excels in the use of quality data management tools such as Agile.
Strong computer skills with a working knowledge of Microsoft Office suite
Strong attention to detail and excellent organization skills
English Language: Knowledge of the meaning, spelling, and use of the English language.
Working Knowledge of ORACLE and Agile application preferred.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor
Primary Location: United States-Massachusetts-Marlborough
Organization: Quality Management Systems
Shift: Day Job
Job Posting: Aug 29, 2017, 9:08:30 AM