Analytical Quality Assurance Specialist(Microbiology)

Position Summary

The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to oversee microbiology and chemistry laboratory activities, ensuring all testing adheres to CGMP and compliance standards. This role involves providing oversight, maintaining data integrity, resolving quality issues, and reviewing QC data for batch disposition.

Responsibilities

• Ensure QC processes are controlled and monitored, identifying and troubleshooting quality issues
• Monitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples, if applicable
• Support method transfer and validation, troubleshooting, cross validation, IQ/OQ protocols
• Document activities with internal reporting
• Identify training needs and ensure company-wide compliance
• Compile and interpret QC Analytical data including Out-of-Specification (OOS) results
• Ensure compliance to data integrity and cGMP in QC lab in line with USFDA standards

Requirements

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent
• 2 - 3 years of experience in Quality Control, or equivalent

Skills

• Excellent analytical skills
• Strong knowledge of CFRs
• Strong interpersonal skills
• Excellent verbal and written communication skills
• Ability to work well in a team environment
• Ability to work independently
• Strong problem-solving skills
• Strong organizational skills