Quality Control & Microbiologist Technician

Quality Control & Microbiology Technician

Reports To: QC Lab Supervisor

Business and Department: Quality

Role Summary

The Quality Control & Microbiology Technician is responsible for performing routine and non routine quality control and microbiological testing to ensure products, materials, and processes meet established quality, safety, and regulatory standards.

This role supports compliance with internal procedures and applicable regulatory requirements while maintaining accurate documentation and a controlled laboratory environment.

Direct Reports

• None

Position Responsibilities Tasks Deliverables

An individual must be able to satisfactorily perform each essential duty listed below. The requirements listed are representative of the knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions.

All duties as assigned and the following specific activities.

• Support production operations by performing microbiological assays in accordance with USP/NF standards and approved inhouse procedures on finished goods, inprocess materials, and environmental swabs
• Conduct routine and non routine environmental monitoring and environmental studies
• Troubleshoot and support investigations related to microbiological failures in production
• Communicate out of specification (OOS) and abnormal results promptly to Quality Management
• Maintain Quality Assurance operations by adhering to quality policies and procedures and accurately reporting required changes or observations
• Perform technical reviews of generated data and provide guidance to internal customers regarding results and trends
• Maintain accurate and complete testing records, both electronic and handwritten, in compliance with data integrity requirements
• Assist with microbiological testing of new formulas and product development initiatives
• Ensure ongoing compliance with current GMP regulations, including American Blending & Filling corporate policies and procedures
• Order, maintain, and manage laboratory supplies and consumables while keeping accurate inventory records to support efficient operations
• Perform routine and general maintenance on laboratory equipment and instrumentation
• Provide, maintain, and manage equipment and supplies for the sanitization and disinfection surveillance programs supporting production and blending departments
• Retain tested samples in the laboratory under controlled conditions until approved disposal is required
• Record, monitor, and document laboratory equipment temperatures in accordance with SOP requirements
• Participate in the internal audit program, including preparation and follow up activities
• Write, review, and revise Standard Operating Procedures (SOPs) as required
• Generate and review product testing result reports for accuracy and completeness
• Review production batch records to verify accuracy and completeness, and approve intermediate products for use in production
• Weekend work and flexible shift scheduling may be required, as needed, to support production schedules and business needs

Key Performance Indicators (KPIs)

An ongoing outcome that is measurable.

• First pass raw materials
• First pass FG
• Environmental swab results
• Batches tested during the month.

MISCELLANEOUS

• Travel: