Major Accountabilities
Provides facility support through the collection and testing of site clean utilities (e.g. water stem and compressed gases)
Performs microbiological testing (e.g. Bioburden Endotoxin and Growth Promotion) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
Performs environmental monitoring of controlled manufacturing environments
Ensures laboratory maintains inspection readiness data integrity and Current Good Manufacturing Practice (CGMP) compliance
Assists management with technical services such as initiating events (e.g. deviations and non-conformances) within quality systems
Identifies and solves problems while consulting and under the direction of management
Assists with laboratory equipment qualification and validation activities
Participates in project developments from concept through execution ensuring alignment with organizational goals. Performs other duties as assigned
Knowledge Skills or Abilities
Knowledge of aseptic techniques and behaviors
Effective communication both written and verbal
Technical writing and problem-solving skills
Ability to complete work both independently and under guidance from Supervision
Ability to systematically approach daily tasks
Ability to effectively collaborate with coworkers and internal clients
Knowledge of United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Willingness to incorporate lean lab and six sigma principles into the work environment
Ability to manage and complete tasks according to a structured plan
Knowledge and familiarity with data management systems (e.g. TrackWise LIMS) and capability to learn basic use and navigation within the systems
Must be flexible to support 24/7 manufacturing facility
Minimum Education and Experience Requirements
High School Diploma/GED with 6 years of Microbiology experience; or
Associates degree in Life Science Pharmaceutical or related field with 2-4 years of Microbiology experience; or
Bachelors degree in Life Science or Biology with 1-2 years of Microbiology experience
Experience with data management systems (e.g. LIMS TrackWise)
Preferred Education and Experience Requirements
2 years of CGMP laboratory experience
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. No X Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. No X Yes 2-8 C Range (If yes specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes