Microbiology Analyst I

Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.

Area Of Responsibility

• Record GMP data, monitor and evaluate QC systems and equipment
• Recommend improvements to procedures, and revise SOPs and GMP documentation as required
• Interact with internal and external auditors including government agencies and contract manufacturing representatives
• Perform release, stability, validation and complaint follow-up assays on raw materials, in-process and final products
• Perform microbial identification related to product and environmental testing
• Perform sampling of raw materials as required for QC testing
• Perform routine quality control testing as required and monitors or evaluate systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
• Maintain records in paper based or computer based systems
• Execute method validation protocols related to product testing
• Author summary reports for executed method validations
• Author deviation reports and microbiological assessment reports related to departmental activities and product support
• Provide technical input on product testing issues and instrumentation/equipment
• Serve as liaison to service, calibration and technical representatives
• Conduct and document assay failure and complaint investigations
• Ensure that laboratory is in cGMP compliance and conduct inspections
• Other duties as assigned

Work Conditions

• Lab
• Office
• Laminar flow and biosafety hoods
• Exposure to noise, bio-hazardous (live cultures), and chemicals
• May entail exposure to radiation within NRC limits
• Exposure to or use of syringes and needles
• Exposure to non-hazardous and hazardous chemicals and materials
• Exposure to biological safety cabinets
• Requires work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes
• Moderate noise, oven heat, open flame, chemical fume hoods areas requiring wearing appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)

Physical Requirements

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
• Close vision; depth perception; ability to adjust focus
• Use of repetitive motion
• Able to operate computer/office machines
• Lift up to 25 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• BS in Microbiology or relevant experience required

Experience

• 0-2 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
• Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product
• Excellent verbal, written and interpersonal communication skills
• Proficient at following specific instruction (i.e. written SOPs)
• Working knowledge of cGMP/GLP
• Good computer skills including word processing and working with spreadsheets

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).