Conduct microbiological assays, perform routine environmental monitoring, and the qualification of laboratory methods and equipment.
Essential Duties and Responsibilities
Write protocols/methods/SOPs as required.
Conduct testing such as microbial limits, microbial limits preparatory testing preservative effectiveness, enumeration of organisms, growth promotion testing, routine environmental monitoring, vitamin and antibiotic assays, and organism identification.
Calibrate instruments and perform instrument qualifications as required.
Train/mentor on sample release testing methods, water sample collection techniques, and other types of microbiological training as required.
Interface with other departments daily to answer questions or communicate sample status.
Conduct method validation testing as required.
Perform other related duties as assigned to meet departmental and Company objectives.
Knowledge of USP, EP, JP and other compendial methods and use of equipment related to performing microbiological testing methods
Good working knowledge of aseptic techniques.
Method development and writing skills.
PC proficiency using Microsoft Office suite.
Good communication skills.
Proven ability to use microbiological testing equipment.
Bachelor's degree in Microbiology, Biology or related science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
Five years' experience in pharmaceutical microbiological testing or foods/cosmetics testing; or
Associate's degree in Microbiology, Biology or related science and nine years' pertinent and progressive pharmaceutical or other highly regulated industry experience.
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:
Stand, walk, sit, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk, and hear.
Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull or otherwise move objects.
The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:
Individual is in a proximity to moving mechanical parts and exposure to chemicals.
Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
We are an equal opportunity employer M/F/D/V.
Nesher Pharmaceuticals (Usa) LLC