Qc Microbiologist Jobs

The QC Microbiologist is responsible for performing routine microbiological testing in a pharmaceutical/ nutraceutical manufacturing facility. The QC Microbiologist will continue to assure that Microbiology Lab operations and testing are performed in compliance with applicable regulations, company specifications, procedures/policies and current industry practices. The QC Microbiologist will work with the QC Manager to select equipment and instrumentation, establish laboratory systems, develop procedures, and conduct investigations. The QC Microbiologist will implement standard analytical methods and documentation, as well as manage lab supplies and inventory.

DUTIES AND RESPONSIBILITIES:

The QC Microbiologist contributes to proper control of all aspects of New Vision Pharmaceuticals facility that may impact microbiological quality including; manufacturing processes and equipment, materials utilized, physical facilities, environmental conditions, specifications, cleaning and sanitization, sampling and testing, personnel practices/procedures, etc.

• Performs sampling and testing as required for monitoring of critical systems; Purified Water, Clean Steam, Clean Compressed Air, etc.
• Performs laboratory investigations for out of specification (OOS) microbiological testing results, and other microbiological laboratory non-conformances using established procedures under the direction of the QC Microbiology Manager.
• Performs quantitative and qualitative microbiological tests for media controls, enumeration, sterility testing, absence of index organisms, classification and speciation, antimicrobial effectiveness, etc.
• Performs calibration checks and performance checks of instrumentation and devices such as, but not limited to RCS unit, pH meters, balances and refrigerators.
• Maintain proficiency in all Microbiology laboratory methods, processes, and procedures.
• Performs sampling and testing as required for environmental, personnel monitoring, sampling of raw materials, in-process product, and finished product.
• Understands and complies with cGMP standards, SOPs, Environmental Health & Safety, and Quality requirements and applicable regulations. (Maintains awareness of industry best practices.)
• Prepares samples for shipment to contract laboratories.
• Documents, reviews, evaluates, reports, and archives analytical results. Maintains Laboratory Notebooks and Logs as detailed in applicable procedures. Produces periodic reports for tracking, evaluation of trends, associated metrics, KPis etc.
• Prepares testing apparatus, solutions, media, inocula, cultures, and reagents as required.
• Performs testing in support of product development projects, investigations, and monitoring of utilities systems.