Job Details

  • Title: Manufacturing Specialist-Documentation
  • Code: RCI-20491-1
  • Location: Kalamazoo Michigan (MI) 49001
  • Posted Date: 02/23/2021
  • Duration: 9 Months
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  Job Description

The Manufacturing Specialist-Documentation will develop documents and have responsibility for document review and approval in support of Drug Products Operations. Primary documents include SOP's, Batch Records, and Short Notice Changes.

This position will serve Drug Product Operations customers to develop or modify documents which enable the manufacturing process. These may include SOP's, Batch Records, and Short Notice Changes.

  • Create/Revise documents to achieve clarity and efficiency in the manufacturing operations. Documents may be developed in Microsoft Word or other batch record authoring applications.
  • Function as the responsible person for document changes, using client’s quality tracking system under GMPs and following all site procedures
  • Intake requests for change, create draft documents, confirm consensus and assure required approvals are completed on-time
  • Manage the timeliness of SOP Periodic Review
  • Track due dates and progress for assigned work, report off-track work
ORGANIZATIONAL RELATIONSHIPS
  • Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
  • Process Owners: Line Leads/Technical SMEs, Scientists, Process Engineers
  • Document Approvers: Quality Professionals, EHS Professionals, DP Training team, Drug Product Operations team leads
  • Drug Product Operations Document Team colleagues
  • Project Managers

EDUCATION AND EXPERIENCE
  • Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
  • Bachelor’s Degree with Minimum of 2 years of experience in a pharmaceutical setting including change control and formatting of documents
  • High School Diploma with Minimum of 7 years of experience in a pharmaceutical setting including change control and formatting of documents
TECHNICAL SKILLS REQUIREMENTS
  • Indicate the technical skills required and/or preferred, as applicable
  • Proficiency in use of PC and Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio) is required.
  • Technical writing expertise, strong facilitation, organizational skills, knowledge of applicable SOP’s and GMP’s preferred.
  • Proficiency in Microsoft Office required (Visio preferred)
  • Training and access in Quality Tracking System (Trackwise) preferred
  • Self-motivated with ability to manage workload and gather information in a dynamic environment