Batch Record Review Specialist

3 weeks ago


Maryland City, United States Sonus Software Solutions Inc. Full time

Job Description: Batch Record Review Specialist

Location: Maryland

Work Type: 100% Onsite

Immediate Start Required

We are seeking a highly skilled and qualified individual to join our team as a Batch Record Review Specialist in a Cell & Gene Therapy environment. The successful candidate must have extensive knowledge of all upstream Batch Record Review processes.

Responsibilities:

  • Manage the Batch Record Review process in a Cell & Gene Therapy environment.
  • Ensure compliance with cGMPs and regulatory requirements.
  • Provide technical guidance and support to the team.
  • Collaborate with cross-functional teams to achieve project goals.
  • Develop and implement process improvements.
  • Ensure accurate and timely documentation of all activities.

Qualifications:

  • Extensive experience in upstream Batch Record Review in a Cell & Gene Therapy environment.
  • Excellent technical writing skills and full English proficiency.
  • Ability to start immediately if selected by our client.
  • Attention to detail and strong problem-solving abilities.
  • Commitment to quality and compliance.


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