QC Microbiology & Stability Scientist

Job Summary

This position is responsible for performing microbiological testing, data review, and managing stability program activities in support of product quality, regulatory compliance, and GMP manufacturing. Assist with the QC samples, including raw materials, stability, and finished drug products. This role supports environmental monitoring, microbial testing, stability studies, and data review while ensuring adherence to regulatory requirements and internal quality standards.  

Core Responsibilities

• Ensure compliance with GMP, FDA, and ICH guidelines.
• Prepare and maintain laboratory documentation, including SOPs, protocols, and reports.
• Participate in internal audits, regulatory inspections, and quality improvement initiatives.
• Support deviation investigations, CAPAs, and change control activities.
• Handles all QC samples, including raw materials, finished drug products, and stability samples, for submission to appropriate analytical testing laboratories, including making out submission paperwork or entry forms and shipping the samples to outside laboratories
• Follows up with laboratories on past due test results
• Other duties will be assigned as required to support QC and Quality

QC Microbiology

• Perform routine and non-routine microbiological testing, including:
  • Environmental monitoring (air, surface, personnel)
  • Bioburden testing
  • Microbial limits testing
  • Endotoxin testing
  • Sterility testing (as applicable)
• Conduct microbial identification using approved methods.
• Perform media preparation, growth promotion testing, and equipment qualification.
• Review microbiological data and ensure accuracy, completeness, and compliance with GMP requirements.
• Investigate out-of-specification (OOS), out-of-trend (OOT), and environmental monitoring excursions.
• Support method validation, method transfers, and laboratory investigations.

Stability Program Management

• Coordinate and manage stability studies in accordance with ICH and regulatory guidelines.
• Prepare and maintain stability protocols, schedules, and reports.
• Manage stability sample inventory, storage, and testing timelines.
• Track stability time points and ensure timely testing and documentation.
• Review and analyze stability data to support product shelf-life and regulatory submissions.
• Maintain stability chambers and monitor environmental conditions.
• Enters all stability sample information and data into the stability management software
• Provides stability data and analysis for Annual Product Quality Review (APQR) reports.

Qualifications & Requirements

• Bachelor's Degree in scientific discipline.
• 5 years of pharmaceutical laboratory environment experience; or equivalent combination of education and experience.
• Must be detail oriented
• Must be well organized
• Must have the ability to work on multiple different tasks within a workday
• Must have a positive teamwork attitude
• Excellent interpersonal, oral, and written communication skills
• Maintains confidentiality of sensitive information
• Ability to meet attendance standards. All full-time employees are required to work a minimum of 40 hours in a week.  Sometimes it may be necessary to work additional hours to accomplish the required tasks to meet deadlines

Position Type 

• On-Site

Travel

• None