The QC Scientist-Microbiology is responsible for day-to-day operations of the QC Microbiology laboratory in a cGMP biopharmaceutical pilot plant. The individual prioritizes, oversees, and tracks multiple microbiological projects ensuring timely completion and efficient utilization of staff and equipment. The QC Scientist is responsible for leading and/or collaborating in the routine operation of the microbiology lab. The individual provides technical expertise and trains other analysts on microbiological analyses. The QC Scientist has responsibility for maintaining analytical instruments, using knowledge and experience to appropriately respond to malfunctions, scheduling, monitoring, and interfacing with external personnel as necessary. In addition to prioritizing overall workflow, analyst training and equipment maintenance, the individual provides technical expertise, generates compliant laboratory data for release, validation of assays as appropriate and support of critical utility, environmental and process stream testing. The QC Scientist serves as a first-line resource to other analysts in assessing and resolving technical issues. The QC Scientist authors and updates SOPs for laboratory procedures, and operation of equipment, investigates and documents microbiology alert/actions, OOS/OOT events and implements the appropriate CAPA when necessary. The QC Scientist is responsible assisting with routine trending of critical utilities and environmental monitoring results.
* Schedules and performs (as needed) daily routine microbiological testing including sample collection and testing within the QC Microbiology Laboratory in support of all Pilot Plant needs
* Leads and coordinates investigations on behalf of QC Microbiology. This includes internal investigations as well as processing investigations. Investigate and document assay failures and OOS events and implement associated laboratory CAPA in a timely manner.
* Oversees the work of junior analysts performing all laboratory tasks. Ensures laboratory data generated during testing is captured accurately and timely into respective data systems (e.g., LIMS).
* Performs data review and approval as necessary. Promptly communicates any non-conformances to QC Management and participates in non-conformance resolution as needed
* Coordinates and prioritizes the management of raw materials, data review and data management for the Raw Material Program as well as general laboratory data.
* Oversee routine calibrations and preventive maintenance of laboratory equipment and instruments; and performs instrument qualifications as necessary
* Maintains the laboratory maintenance in a compliant manner by overseeing, coordinating, and assisting with cleaning, inventory, calibration, training, SOP and test method revision
* Leads microbiological projects as necessary
* BS in Microbiology, or other relevant scientific discipline.
* A minimum of 8+ years working experience in a cGMP Quality Control department in an FDA-regulated industry
* Experience in Biopharmaceutical industry required
* Proficiency gained through wide exposure / experience in technical field; broad grasp and application of scientific theory and principles
* Expert working experience with microbiological testing such as membrane filtration and direct plating bioburden, endotoxin testing using kinetic chromogenic systems, microbial identifications and environmental monitoring experience using viable and non-viable methods.
* Strong experience with designing and executing microbial studies and investigations required.
* Strong experience with independent validation of microbial instrumentation required.
* Experience with aseptic technique, TOC and conductivity is required
* Experience with LIMS required
* Ability to perform repetitive tasks while maintaining speed of work and attention to detail.
* Works with other scientists toward achieving goals; information sharing and problem solving requiring monitoring and interpreting data; coordinates or direct others on work efforts
* Expected to conduct projects, evaluate experimental results, provide solutions to problems require choosing from multiple alternatives
* Strong working knowledge of cGMP/ICH/FDA/EMEA regulations and guidelines
* Strong written and oral communication skills
* Ability to identify, investigate, and solve assay and equipment related problems.
* Proficient in MS Office applications; particularly Excel graphing.
* Experience with statistical software such as Minitab© or JMP