Position Summary

The QC Microbiology Associate II performs microbiological testing and laboratory support activities to ensure compliance with current Good Manufacturing Practices (cGMP), company procedures, and quality standards. This position is responsible for the receipt, preparation, testing, documentation, and review of microbiological samples and results. The Associate II supports laboratory operations through equipment maintenance activities, data integrity practices, and adherence to established quality systems. The role requires a strong attention to detail, the ability to work in a regulated laboratory environment, and a commitment to maintaining safe and efficient laboratory operations. This position reports to the QC Microbiology Supervisor/Manager and is based onsite.

In This Role, You Will Have the Chance To:

• Perform microbiological testing on finished products, stability samples, environmental monitoring samples, and other laboratory samples in accordance with approved procedures and test methods.
• Receive, prepare, process, and document samples while maintaining data integrity and compliance with cGMP requirements.
• Record, review, and compile laboratory results, reports, and supporting documentation to ensure accuracy, completeness, and compliance with established specifications.
• Support laboratory equipment calibration, qualification, preventive maintenance, troubleshooting, and routine operational activities.
• Verify test results and ensure compliance with approved procedures, methods, specifications, and quality standards.
• Assist with the development, revision, and continuous improvement of laboratory procedures, test methods, and documentation practices.
• Maintain laboratory cleanliness, organization, and compliance with all applicable safety, quality, and regulatory requirements.

Essential Requirements

• High School Diploma or GED required.
• Minimum one (1) year of laboratory, microbiology, quality control, or related scientific experience.
• Strong attention to detail with excellent documentation and recordkeeping skills.
• Ability to follow written procedures and work effectively within a regulated environment.
• Proficient in data recording, report preparation, and review of laboratory documentation.
• Ability to work independently and collaboratively within a team environment.
• Flexibility to work non-standard hours as business needs require.

Preferred Experience Includes

• Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline.
• Experience working in a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment.
• Familiarity with cGMP regulations, laboratory quality systems, and microbiological testing methods.
• Experience supporting laboratory investigations, equipment qualification, or continuous improvement initiatives.

Physical & Work Environment

• Laboratory-based role requiring frequent standing, walking, bending, and use of laboratory equipment.
• Ability to lift and carry up to 20 pounds occasionally.
• Moderate noise levels typical of a laboratory and manufacturing support environment.
• Required use of appropriate personal protective equipment (PPE) and adherence to all safety procedures.
• May involve exposure to biological materials, laboratory reagents, and controlled environmental conditions consistent with microbiology laboratory operations.