Document Control Specialist

MERCK
Posted on

Type

Administration

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The Documentation Specialist will utilize their experience in organizational, data processing, computer, and document review areas to ensure that all data and documentation is handled in a manner for easy retrieval, control and utilization.  This position will govern the interface between site department users and the electronic document management system (ManGo).  Additional duties include support of all aspects of Quality Assurance functions associated with document coordination, record coordination and control, data entry and reports, and general office support. 

 

Review/approve workflows in the electronic document management system(s).  Provide guidance to system users on change request generation and document formatting. Facilitate review and revision of quality documents for periodical review. Review open change requests to flag aging requests, errors in generation and communicate to originator actions needed. Assist in the creation of draft documents required for Electronic Document Management System. Issue manufacturing, packaging and labeling records to production.  Responsible for data input for Quality Training / General Office Support; Print and prepare labels for issuance to production. Organize and coordinate documents and labels to be issued to production based upon standard operating procedures and established production schedule and timelines. Complete documentation of activities per Good Documentation Practices. Enter data into appropriate databases/spreadsheets for tracking and trending purposes. Participate in process improvement activities to include team participation, data collection and general support. Provide other assistance as required to maintain integrity of document management, data entry and record control. 

 

  • Ensure quality documents reviewed accurately reflect current procedure.  Initiate workflows and approve documents as required to ensure current procedures are maintained.
  • Assist with recalls and field corrections
  • Document all tasks with appropriate detail in writing.
  • Follow quality procedures when review indicates any deviation from current procedure.
  • Utilize system of quality documents for tracking and maintaining control of all documentation.
  • Properly issue and review labels and other quality documentation to change status of materials.
  • Successfully complete required quality training.
  • Write and review drafts of quality procedures as assigned.
  • Record quality observations in databases as directed by supervisor to aid in quality improvement efforts. 
  •  

Preferred Qualifications:

  • Associate Degree in Science or related discipline and 1+ yrs experience in GMP Quality Control, Manufacturing, QA or similar manufacturing environment OR  3+ years similar GMP or relevant experience
  • Working knowledge of cGMP and ISO quality systems
  • Attention to detail skills
  • Time management of multi-tasking
  • Independent, works well with direction
  • Logical approach for understanding systems and problem-solving
  • Excellent Teamwork and cooperation skills

 

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, QA, Quality Assurance, QC, Administrative, Quality, Technology

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More Information

Posted on

Type

Administration

St.%20Louis%2C%20United%20States

St. Louis , United States