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Regulatory & Quality Assurance
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Job Description:
  • Design and implement work instructions, area guidelines, knowledge base topics, and departmental SOPs as required. Contribute to work instructions, area guidelines, knowledge base topics, style guides/templates, and department SOPs.
  • Develop, design, and control instructional and informational tools needed to assure safe, appropriate, and effective use of science and technology, intellectual property, and manufactured products and services. Combine multimedia knowledge and strong communication skills with technical expertise to educate across the entire spectrum of users’ abilities, technical experience, and visual and auditory capabilities.
  • Act as Document Owner for documentation Engineering Change Orders (ECOs) and route documents through the document change control process. Support other Document Owners by documenting changes, including all necessary supporting justifications for changes and compiling accurate and complete documentation packages. Contribute to work instructions, area guidelines, knowledge base topics, style guides/templates, and department SOPs. With direction, work closely with other technical writers and stakeholders to develop and produce documents. Assist in the development and revision of documents, following established style and format guidelines. Proofread and review documents.
  • Attend project/core team meetings as required.
  • Create new documentation (Package inserts and/or operator manuals) and improve existing documentation.
  • Initiate, edit, review and approve document changes.
  • Revise existing documentation by working with stakeholders, partners, or distributors to facilitate revision, review, and approval of documentation.
  • Identify and implement document changes to maintain consistency across product
    lines/processes.
  • Lead collaborative review sessions.
  • Coordinate the collaborative review process and establish review and edit cycles.
  • Assist core team members and project team leads in the developing documentation timelines and deliverables.
  • Coordinate the transition of documentation through development, pilot and production phases as appropriate.
  • For ERs/CAPAs, conduct investigations, provide solutions, implement changes, and write technical reports as required.
  • Through Technical Training, maintain and expand knowledge of manufacturing processes, assays, instrumentation, and software as it applies to documentation.
  • Manage multiple documentation projects at a time.
  •  Prioritize deliverables and manage “expedites”.
  • Coordinate final production of documents with print vendors as required.
  • Information Design and Development: work with translation vendors in managing translation development and procurement process.
  • Quality Control: As required, assign document change responsibilities and provide training and assistance to EDMS users.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
  • Problem Solving & Analytical Skills
  • Project & Time Management Skills
  • Intermediate Technical Writing Theory & Practices
  • Design Theory
  • Interpersonal skills
  • Technical skills
  • Troubleshooting Skills
  • Communication Skills, Detail Orientation, Organizational Skills, Learning, Teamwork
Computer Skills:
  • Advanced proficiency in FrameMaker and Word.
  • Proficiency in Madcap Flare is a plus.

 

Education:
  • Typically requires BA or BS.
 
Experience:
  • 5-8 years related experience.
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 inclusive of disability and veterans.

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