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Batch Documentation Support Specialist

PublishedPublished: 6/14/2022
Technology

Job Description

Job Description

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a Batch Documentation Support Specialist .

Position Type:

  • Contract
  • Onsite

Required:

  • Strong math and documentation skills.
  • Experience with cGMP/GDocP preferred.
  • Ability to work independently in a fast-paced environment.
  • Must not be allergic to penicillin or cephalosporin (if applicable).
  • Flexible schedule; some weekends required.

Responsibilities:

  • Enter batch record information accurately during production.
  • Perform and double-check calculations.
  • Guide operators on required documentation.
  • Ensure GDP and cGMP compliant documentation.
  • Reference master batch records to ensure matching steps and data.
  • Monitor in-process checks and documentation completeness.
  • Identify and escalate documentation gaps.
  • Support organization and retrieval of documentation.
  • Provide documentation coaching on the floor.
  • Participate in audits and support continuous improvement.
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