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The Global Laboratory Services group at Avantor is looking for a QA Analyst to support compendial updates, change management, method validation protocols and ensure analytical methods are kept in a state of compliance.

Requirements

• Experience in a cGMP lab; science background preferred.
• Understanding of GxP principles.
• Experience with data entry and databases, related software, and document control systems.
• Knowledge of QMS.
• Good computer skills with knowledge of Microsoft Office functionality.
• Understanding of SAP, LabVantage LIMS and Document control platforms (i.e., EtQ, etc.).
• Familiar with USP, EP, BP, JP, ChP, FCC, ACS, etc.

Responsibilities

• Supports Compendial Compliance activities, as directed, for USP, EP, BP, JP, ChP, FCC, etc.
• Supports global process for compendial management and update activities.
• Manages compendial related document updates, as needed.
• Responsible for analyzing analytical method parameters using defined procedures.
• Executes operational plans for job area and implements new products, processes, standards, or operational plans that will have a significant impact on the achievement of sub-function results driven by compendial update.
• Reviews laboratory CAPAs to ensure an effective CAPA plan and acceptable interim control and manage updates to analytical methods / specifications.
• Drive process improvement for Global Analytical Method Transfers and Global Compendial Management.

Other

• Bachelor’s degree, in a Science related field or equivalent/applicable experience.
• 2+ years of applicable experience.
• Must be detailed oriented, with strong organizational skills, ability to multi-task, prioritize workload and work independently to meet commitments with minimal supervision.
• Works independently with limited oversight from manager.
• Must be able to engage Quality Management regarding elevated risk factors.