QA Associate/Senior Associate – Quality Assurance (Job Code: QA)

The QA Associate/Senior Associate is mainly responsible for performing and managing the audit of Analytical GMP and Bioanalytical GLP data packages from the laboratory.

Duties and Responsibilities

• Performs periodic audits of data packages
• Works with clients and managers to develop project QA plans
• Helps to train other associates in QA
• Prepares, manages, and maintains the training file documents
• Assures adherence of acceptable GMP and GLP practices by the staff
• Performs training within the group or throughout the organization as needed
• Ensures timely completion of all quality plan objectives and milestones
• Supports the on-time performance metric
• Ensures compliance with applicable regulatory guidelines
• Participates in regulatory and partner inspections as necessary. Ensures timely follow-up to inspection findings

Qualifications:

• 2-5 years of experience in the Analytical GMP and/or Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree
• Previous technical experience in the areas of chemistry, biochemistry, or biology
• Must possess a working knowledge of GMP/GLP requirements and other policies/regulations as applicable
• Must possess a conceptual understanding of all Quality functions and business areas
• Must have the ability to function in a fast-paced environment and communicate effectively with management.