SUMMARY: The Senior Microbiologist oversees the microbiological testing of samples submitted to the laboratory. The primary functions are to oversee routine microbiological analyses, develop new methods for routine use, and ensure the facilities and processes adhere to GMP and ISO guidelines. The Senior Microbiologist trains and supervises the Microbiologists.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following. Management retains the right to add to or change the duties of the position at anytime. The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.
Train and supervise the daily activities of the Microbiologists. Manage the training schedule matrix for the Microbiology lab.
Develop, implement and continuously improve the systems, procedures and record-keeping necessary for the organized and efficient receipt of samples for microbiological testing.
Develop, validate, and continuously improve microbiological sample specifications and testing methodologies.
Oversee the assigned testing of samples submitted to the laboratory. Render dispositions (in-specification or out-of-specification) based on results.
Troubleshoot anomalous results generated by the microbiology laboratory. Perform testing in support of OOS investigations.
Develop and implement advanced microbiological laboratory instrumentation maintenance and calibrations programs.
Develop, implement and control the systems, procedures and record-keeping necessary for the organized and efficient reporting, peer-review, and archiving of laboratory testing & calibration data.
Guarantee the safe and correct use, sterilization and disposal of laboratory reagents, media, samples, etc., and maintain any state and Federal license necessary for the possession of testing and/or research chemicals.
Participate in the environmental monitoring of manufacturing areas, equipment and utensils as contracted by SORA customers.
Develop and validate manufacturing environmental monitoring programs, including cleaning validation studies, as contracted by SORA customers.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Possess expertise and proficiency with microbiological equipment and techniques. The handling of pathogenic materials is required.
Be able to read, analyze, interpret and author testing methods, standard operating procedures, and study protocols.
Be able to work independently, and to interact with scientific peers in an effective manner.
Be willing to work extended hours, weekends and holidays when needed.
The position requires extensive standing. The employee is regularly required to walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds.
EDUCATION and/or EXPERIENCE: Bachelor’s degree in Microbiology with 3 or more years of pertinent laboratory experience. Previous supervisory experience a plus.
WORK ENVIRONMENT: Work is carried out in an analytical laboratory within a factory setting. There is considerable exposure to raw materials and chemical reagents. Personal Protective Equipment such as lab coats, gloves, hair nets, safety glasses and respirators must be worn as defined by safety policy.
TRAINING REQUIRED: per SORA SOP# 52-152-010