QC Microbiology Assoc I (Sun-Tues/Wed 5:30pm-5:30am)
Position Summary
The QC Microbiology Associate performs routine microbiological testing and laboratory support activities to ensure the safety, quality, and compliance of B. Braun products and manufacturing processes. This role supports environmental monitoring, microbial testing of finished products, utilities, raw materials, and stability samples in accordance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements. Working in a laboratory environment, the QC Microbiology Associate is responsible for generating accurate test results, maintaining laboratory equipment, and supporting continuous improvement initiatives within the Quality Control Microbiology department. This position is onsite and collaborates closely with Quality, Manufacturing, and Technical Services teams to support product quality and patient safety.
In This Role, You Will Have the Chance To
- Perform microbiological testing, including sample receipt, preparation, incubation, enumeration, identification, and documentation of test results for finished products, stability studies, utilities, environmental monitoring, and other assigned samples.
- Accurately record, review, and maintain laboratory data and documentation in compliance with cGMP requirements, laboratory procedures, and data integrity standards.
- Support laboratory operations by maintaining equipment, media, reagents, and supplies to ensure uninterrupted testing activities.
- Assist with equipment qualification, calibration, preventive maintenance, troubleshooting, and performance monitoring activities.
- Review test results for compliance with specifications, procedures, and regulatory requirements and promptly escalate atypical findings.
- Support investigations related to out-of-specification (OOS), out-of-trend (OOT), and laboratory deviations as assigned.
- Participate in the revision and improvement of laboratory procedures, test methods, and standard operating procedures (SOPs) to support continuous improvement initiatives.
Essential Requirements
- High School Diploma or GED required; Associate degree in Microbiology, Biology, Biotechnology, or a related scientific discipline preferred.
- 0-2 years of experience in a microbiology, laboratory, pharmaceutical, medical device, biotechnology, or related regulated environment.
- Basic knowledge of microbiological techniques, aseptic practices, and laboratory safety procedures.
- Ability to follow written procedures and accurately document laboratory activities.
- Strong attention to detail and organizational skills with the ability to manage multiple priorities.
- Basic computer proficiency, including Microsoft Office applications.
- Ability to work in a team-oriented environment while maintaining compliance with quality and safety requirements.
Preferred Experience Includes
- Experience working in a cGMP-regulated pharmaceutical, medical device, or biotechnology environment.
- Hands-on experience with environmental monitoring, bioburden testing, microbial identification, or sterility testing.
- Familiarity with laboratory systems, data management software, and electronic documentation practices.
- Knowledge of USP microbiological testing requirements and contamination control principles.
Expertise: Knowledge & Skills
- Assignments are routine and performed according to established laboratory procedures and work instructions.
- Works under direct supervision with increasing independence as proficiency is demonstrated.
- Uses established methods to perform testing and complete assigned tasks.
- Exercises limited judgment in resolving routine laboratory issues and escalating concerns appropriately.
- Regular interaction with supervisors, peers, Quality, and Manufacturing personnel.
Pay
$23.68 - $28.37/hr