QC Microbiologist II
- Employer
- Sun Pharmaceuticals, Inc
- Location
- Billerica, Massachusetts, US
- Salary
- Competitive
- Closing date
- Jun 3, 2021
View more
- Sector
- Consultancy/Private Sector
- Field
- Conservation science
- Discipline
- Other
- Salary Type
- Salary
- Employment Type
- Full time
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QC Microbiologist II
Location MA, Billerica
Job Category Quality Control
Employment Duration Full time
Perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology
- Record GMP data, monitors and evaluates QC systems and equipment
- Implement improvements to procedures, and revises SOP's and GMP documentation as required
- Interact with internal and external auditors including government agencies and contract manufacturing representatives
- Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products
- Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance
- Perform and review growth promotion testing data for qualification of microbial culture media
- 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 evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
- Maintain records in paper based or computer based systems
- Author and execute method validation/suitability protocols related to product testing
- Author summary reports for executed method validation/suitability protocols
- Author deviation reports and microbiological assessment reports related to departmental activities and product testing
- Review Microbiology testing data as required
- Coordinate receipt of raw material, in-process and final product samples for testing
- Maintain metrics for receipt and processing of samples for microbiology testing
- 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
- Perform other duties as assigned
Qualifications
- 2-4 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
- ???????BS in Microbiology or related field required
- 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
Location MA, Billerica
Job Category Quality Control
Employment Duration Full time
Perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology
- Record GMP data, monitors and evaluates QC systems and equipment
- Implement improvements to procedures, and revises SOP's and GMP documentation as required
- Interact with internal and external auditors including government agencies and contract manufacturing representatives
- Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products
- Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance
- Perform and review growth promotion testing data for qualification of microbial culture media
- 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 evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
- Maintain records in paper based or computer based systems
- Author and execute method validation/suitability protocols related to product testing
- Author summary reports for executed method validation/suitability protocols
- Author deviation reports and microbiological assessment reports related to departmental activities and product testing
- Review Microbiology testing data as required
- Coordinate receipt of raw material, in-process and final product samples for testing
- Maintain metrics for receipt and processing of samples for microbiology testing
- 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
- Perform other duties as assigned
Qualifications
- 2-4 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
- ???????BS in Microbiology or related field required
- 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
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