Quality Control Microbiologist

The Quality Control Microbiology, QC Analyst will be responsible for collecting environmental samples in clean room areas to support manufacturing operations, sample management activities, and testing of cell therapy in-process and release product samples. The person will be responsible for reporting data and writing/revising standard operating procedures (SOPs) and test methods. This position will also provide support to assist the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing.

The QC Analyst I/II, Microbiology will partner with the QC analytical team, interface with multiple groups including manufacturing, and must have the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.

Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs.

HOW YOU WILL MAKE AN IMPACT

• Perform environmental monitoring of cleanrooms and controlled areas

• Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.

• Perform routine and non-routine quality control testing on in-process samples and finished products.

• Execute sampling and sample management activities per procedure or written protocols.

• May participate in alert/action excursions, investigations, change controls and CAPAs.

• Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance.

• Provide support for method transfers/qualification/validation and stability testing.

• Support analytical equipment installation and qualification

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

• Review all data in accordance with applicable procedures and cGMP requirements.

• Author/review SOPs, Test Methods, and other procedures required to operate a QC laboratory.

• Participate in internal and external audits, inspections, investigations, change controls and CAPAs

• Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.

• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.

• Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.

• Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.

• Communicate effectively with cross-functional peers, and department management.

WHAT YOU WILL BRING

• Bachelor's Degree in scientific discipline, Microbiology focus preferred.

• 0-7 years of relevant experience in cGMP Quality Control Laboratory.

• Hands-on experience with various analytical techniques such as pH, osmolality, Gram stain, endotoxin, sterility, and mycoplasma.

• Experience with environmental monitoring working in an Aseptic Processing manufacturing facility is a plus.

• Knowledge of cGMP/ICH/FDA regulations.

• Ability to independently prioritize/manage activities.

• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail.

• Proficient in MS Office applications and information technologies that support documentation and data management systems.

• Strong troubleshooting, problem-solving skills, oral and written skills.

• Ability to multi-task and interact with multiple groups in a team-oriented environment.