Documentation Specialist – Bausch & Lomb

473BR Position Summary:

  • Facilitate Document Management process in accordance with the requirements of the Document Management, Training, Change Management and other relevant Quality Systems.

Specific Job Duties:

  • Coordinate document lifecycle management by processing Document Change Orders, facilitating the review, approval, distribution and monitoring of documentation.
  • Facilitate awareness of and compliance to the Bausch & Lomb Quality Management System and applicable FDA regulations and ISO standards within the scope of the Document Management Practice.
  • Maintain document indexes and Device Master Records with a high degree of accuracy.
  • Apply expertise in template and form design, as well as best practices in document design and construction.
  • Engender a sense of ownership and active participation among and between content owners and their internal customers and stakeholders.
  • Train Bausch & Lomb staff in the company’s document management process and electronic document control system. Training modes to include one-on-one, role based instruction, group demonstration and web-facilitated teleconference.
  • Issue periodic user communications related to system enhancements, rollouts and other relevant updates.
  • Collaborate with Technical support staff and system user community to understand business requirements and translate them to actionable system requirements.
  • Initiate and facilitate process improvement through close collaboration with document management professionals and their customers throughout the organization.
  • Facilitate efficient document lifecycle flows through timely and concise communication with business users.
  • Engage in system design, development, testing and support activities, and participate actively in the change management process, ensuring that established system lifecycle management processes are strictly followed.
  • Manage document translations through interaction with external service providers and internal content owners and review teams.
  • Lead and project manage document management process and software system implementations supporting global facilities and functions.

Required Skills:

  • Expert level competency with MS Office applications, including MS Word, Excel, Powerpoint and MS Visio, including template and form design and document construction best practices.
  • Deep understanding of document, records management and training practices in medical device or pharmaceutical organizations or other highly regulated industries.
  • Ability to manage multiple priorities and apply sound decision making and problem solving methods.
  • Ability to develop and deliver training content based on processes established through documented procedures to a broadly varied audience.
  • Ability to assess audience needs, adapt material and delivery to those needs, and assess the effectiveness of delivery through established metrics.

Desired Skills:

  • Moderate level competency in the use of online training author-ware, such as Adobe Captivate.
  • Moderate level competency in Web authoring and publishing as well as solid fundamental understanding of HTML.
  • Project Leadership including experience coordinating the activities of cross functional teams and/or geographically distributed teams. • BS or BA degree in a business, technical or scientific discipline required.
  • Advanced certification in a related field (ie: quality, training technical writing, English, etc.) desired.

Experience:

  • Minimum of 3 years of experience in a quality systems, regulatory affairs or compliance role within the life sciences field, including experience in the document management field. Strong working knowledge of Document and Records Management ISO and FDA requirements.
  • Significant experience with enterprise applications, such as Document and Content Management tools, and Quality Systems platforms supporting CAPA, Change Control and Learning Management
  • Status – Full-Time
  • Work Location – Rochester NY – 1400 N. Goodman St.
  • Relocation available

To submit application:

https://sjobs.brassring.com/1033/asp/tg/cim_default.asp?SID=^8K_slp_rhc_HG0/zlufyWffp03G4MgNxe625qNf6NlI9ZUQhndfJ6f2Re_slp_rhc_1zwQ==