Aegis Worldwide is seeking an experienced Microbiology Quality Control Technician to conduct a range of microbiological testing and quality control procedures in compliance with cGMP and global regulatory standards. This role involves performing sterility, endotoxin, bioburden, and other microbiological tests on pharmaceutical products, intermediates, and raw materials. Ideal candidates will be detail-oriented, capable of independent judgment, and thrive in a collaborative and fast-paced laboratory environment.
Key Responsibilities
- Ensure compliance with regulatory standards including FDA, EU, ISO, USP, NRC, TGA, and cGMP requirements.
- Perform aseptic testing for sterility, endotoxins, particulates, and bioburden on drug substances and components.
- Execute in vivo biological performance testing to support product efficacy and quality standards.
- Conduct growth promotion testing of microbiological media as per USP guidelines.
- Prepare and evaluate biological indicators for validation and qualification processes.
- Interpret microbiological growth data, subculture isolates, and maintain detailed records in LIMS (Laboratory Information Management System).
- Support laboratory investigations, corrective and preventive actions (CAPAs), and trending for alert recovery.
- Perform laboratory housekeeping, equipment maintenance, and monthly safety inspections.
- Contribute to technician training and maintain accurate inventory of lab supplies.
- Adhere to safety protocols, radiation protection standards, and internal SOPs.
- Participate in mandatory regulatory and safety training sessions.
Qualifications & Requirements
- Associate degree in life sciences or completion of 4 college-level life science courses required; equivalent work experience considered.
- Minimum of 5 years' relevant experience in microbiology or quality control within a cGMP-compliant pharmaceutical or biotech environment.
- Willingness to perform in vivo testing as part of product efficacy evaluations.
- Strong knowledge of microbiological techniques and aseptic procedures.
- Excellent written and verbal communication skills.
- Proficient in Microsoft Office and laboratory software systems.
- Strong analytical, organizational, and time management skills.
- Ability to work independently and collaboratively while managing multiple priorities.
- Demonstrated commitment to quality, safety, and continuous improvement.