Summary:
Responsible for assisting with the operations of the QC Microbiology Laboratory including environmental monitoring, raw material, component, in-process and finished product release, stability testing, assisting in method validations, instrument maintenance, document generation and review, and other duties as assigned.
Essential Duties:
· Perform environmental monitoring of cleanrooms, purified water, and other systems.
· Perform incoming raw material, component, in-process, finished product release and stability testing.
· Assist in maintaining the laboratory in accordance with SOPs, cGMPs, OSHA and FDA regulations.
· Assist in the trending of environmental monitoring data.
· Calibrate, operate and maintain laboratory instrumentation for product testing, including routine preventive maintenance and troubleshooting.
· Write, revise and review Standard Operating Procedures and Forms.
· Review and approve laboratory data.
· Assist in conducting and documenting laboratory investigations.
· Maintain supplies inventory
· Coordinate instrumentation maintenance and repair work.
· Other duties as assigned.
Qualifications:
· Bachelors degree in Microbiology, Biology or related field
· Experience performing laboratory analyses is preferred
· Good technical writing and organizational skills
· Capable of adjusting priorities in response to changing conditions and schedule
· Experience with Microsoft Office programs
· Good interpersonal skills
· Ability to work well in a team environment