Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.
The Document Control Specialist 2 independently reviews the structure and release of files of engineering drawings, validation/verification protocols/reports, specifications, product proposals, marketing literature, QMS procedures, Design History Files (DHFs), and other Device Master Record (DMR) documentation. Ensures items are released and controlled in conformance with internal procedures and regulatory requirements.
Provides guidance to end users on correct process and procedures to follow based on change content. Reviews documents for accuracy and completeness from a system, procedural, and compliance point of view. Oversees divisional document control processes and systems to ensure documents meet Hologic, and regulatory, document control standards. Maintain logs, databases and catalogues as applicable. Perform additional tasks as directed by manager.
Identifies deficiencies in the process, creates improvements, implements applicable changes, consults with necessary cross-functional teams, and escalates as needed. Responsible for evaluating the system for areas to improve and leading enhancement requests. Advises end users on system capabilities and limitations for process execution and system enhancements. Serves as primary point of contact for cross-functional initiatives to improve various processes impacting the PLM system and/or the ERP system.
Applies acquired job skills, company policies, and procedures to complete assigned tasks. Independently follows established procedures on routine and non-routine work with minimal oversight. Utilizes knowledge of change order systems, processes, and procedures to develop and administer end user training for both change originators and other change analysts.
Subject Matter Expert on the execution and implementation of document control processes and procedures for the division. Lead, propose develop and implement system enhancement and process improvements. Primary point of contact with Corporate IT for any integrations (systems or company). Understand and implement the quality system procedures impacting responsibilities tied to change control. Responsible for revision control and control of document access. Independently review change files to identify deficiencies in accuracy, completeness, or duplication. Provide independent guidance to end users and respond promptly to requests for documents or information. Participate in audits and inspections with respect to document control processes, reports, or systems.
Ability to work on a private network. Detail oriented and highly organized. Strong written and verbal communication. Strong interpersonal skills and comfortable interacting with all levels of the organization. Microsoft Office, Adobe. Familiarity with Oracle, Agile and SharePoint is beneficial.
Preferred Minimum Non-Technical Degree: High School (H.S./GED) or Associate Degree. 1-2 Years experience with a document management system supporting change control. Prior experience with document control support is beneficial. Experience with a digital document control system is beneficial.
The annualized base salary range for this role is $98,400 to $163,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Document Control Analyst 2 • Newark, DE, United States
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