Specialist, Document Control

MERCK
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This position will be responsible for the entry and handling of controlled documentation for Master Product; Specifications (MPS), Standard Operating Procedures (SOP) and other controlled documents as part of the ISO 9001 Document Control System; Maintenance of controlled information in ERP systems; Facilitation of electronic systems supporting site’s Quality Management System (QMS).

 

  • Maintains Controlled Documents: Enter and maintain information in appropriate software.
  •  Reviews draft documents (forms/fields) for accuracy, clarity, completeness, and proper authorization.
  • Works with submitters of documents to get information into the system.
  • Provides guidance / training to employees about document control process.
  • Tracks documents when signed out for retests, review, revisions, etc.
  • Handles obsolete documents (referenced, usages, and files).
  • Re-issues documents for training checklists.
  • Facilitates records retention program
  • Reviews submitted information (new and revisions) for accuracy, clarity, completeness, and proper authorization.
  • Provides guidance / training to employees about revisions to controlled information.
  • Provides information from controlled systems upon request.
  • Assigns new product numbers: finished goods, intermediates, test mixes, and raw materials.
  • Deletes products in appropriate systems.
  • Assists in the maintenance of Corrective Actions, Preventative Actions, Deviations, Customer complaints, Supplier Quality Management program and training system.
  • Facilitates maintenance of department metrics.
  • Maintains site signature log.
  • Posting and maintaining information in electronics systems.
  • Facilitation of existing systems or programs.
  • Occasional trips into laboratories to seek information.
  • Ability to move to other areas in the plant as needed.

 

 

  • Strong knowledge and demonstrated use of standard PC software, Excel, Word, PowerPoint
  • Ability to create, edit and maintain documentation
  • Ability to create and maintain data files and charts in excel or other programs
  • Strong communication skills
  • Knowledge of ISO standards and requirements of a quality system.
  • Ability to operate PC and telephone

 

Working time model:  full-time

US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Document Control, Quality Manager, ERP, Testing, Administrative, Quality, Customer Service, Technology

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Bellefontaine , United States