What are the responsibilities and job description for the Microbiology Analyst I position at SUN PHARMA?
Job Summary
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
Up to 0%
Education and Job Qualification
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
- 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)
- 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.
Up to 0%
Education and Job Qualification
- BS in Microbiology or relevant experience required
- 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
