Quality Assurance Associate I

Responsibilities

• Review and approve documentation associated with incoming biopsies.
• Review and approve documentation associated with incoming materials.
• Review and approve records and associated data in support of cGMP operation activities.
• Create batch records, product labels and perform label verification processes.
• Perform quality reviews and approvals of batch records.
• Responsible for dispositioning batches.
• Participate in company projects as a quality representative.
• Participate in risk assessment activities.
• Perform investigation report writing, reviewing and closing investigation reports.
• Conduct and document training events.
• Manage customer complaints.
• Author quality system documents.
• Perform various office-related duties; filing, scanning, and data entry.
• Promote GLP/cGMP environment and follow procedural guidelines.

Qualifications

• Undergraduate degree in any Life Sciences and 1-3 years’ relevant experience or 6 years direct, relevant experience in Quality Assurance to provide a comparable background.
• Minimum of 3 Years' Experience In Quality Assurance.
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Knowledge of cGMP regulations and good documentation practices.