Job Description
Our client is currently seeking a QA Operations Consultant to assist with CMO oversight, batch record review for ongoing lots, supporting documentation coordination, and approval of materials for release for clinical use or further processing. There will be direct interaction with the CMO, Quality & Manufacturing Groups and excellent communication skills will be needed for this role as well as assertive problem-solving skills are required.
GxP supplier qualifications, assisting with audits, development of audits, audit plans, reports and quality agreements.
Provide support for CAPA’s, change controls, investigations and other application quality systems affecting clinical materials.
Required Skills
At least 5-7 years in GMP Quality and/or GMP/FDA Compliance – REQUIRED
Previous Veeva Systems experience – REQUIRED
Experience managing CMO’s – REQUIRED
Self-motivated, analytical problem solving skills, and demonstrated ability to conduct work independently. – REQUIRED
Familiarity with EU GMPs, ICH guidelines.
Background working in Pharmaceutical or Biotechnology Industries
Remote in MA: QA Ops (232441)
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