Independently performs routine and R&D testing for microbial examination testing on raw material and finished product, environmental monitoring of Production facilities and Microbiology laboratory, purified water quality monitoring, and isolate identification. Performs testing in accordance with USP, cGMP, environmental and safety regulations, involving instrumentation, qualitative and quantitative analysis.
Responsibilities:
Performs microbial and environmental testing according to written procedures and official compendia in compliance with cGMP, environmental, and safety regulations.
- Proficiently operate, maintain, qualify and calibrate the instrumentation/equipment associated with testing.
- Responsible for preparing technical and annual reports for the Quality Control department, in addition to Standard Operating Procedures and Test Methods.
- Responsible for sampling, testing, and releasing all the sample points described in the Environmental Monitoring (EM) Program and utilities testing procedure.
- Responsible for ensuring all microbiological testing is performed in a sterile and/or aseptic environment.
- Responsible for performing all microbiological tests associated with validations, such as cleaning or Operating Procedures, Safety and equipment validations.
- Responsible for performing all microbiological tests associated with product stability studies and Research and Development.
- Responsible for performing bioburden and LAL testing.
- Participates in the support of compliance with the environmental control requirements of classified areas, environmental control for non-sterile pharmaceutical products, qualification of new or renovated areas, and cleaning validation requirements.
- Participates in activities associated with internal/external audits, when required.
Technical Knowledge and Skills:
Experience in pharmaceutical microbiology laboratories and production areas.
- Ability to identify and solve problems, and to independently manage multiple activities/projects to ensure timely completion
- Utilize scientific based rationale and risk based analysis decision making tools.
- Ability to provide leadership behaviors including change management, inspiration, courage and communication.
- Ability to work in a team environment.
- Ability to work various computer applications
- Overall knowledge of Laboratory equipment operation and calibration
Required Qualifications:
B.S. in Microbiology/Biology, preferred Masters in related field with at least four (4) years of microbial/pharmaceutical experience in a quality control and/or combined research lab setting to include: sterility testing, in-process testing, environmental monitoring and microbial identification.
