Piper Life Sciences is currently looking for a QC Analyst, Microbiology in Summit, NJ to work for a cutting-edge bio pharmaceutical organization in support of the Quality Control group to maintain process optimization and manufacturing activities.
Responsibilities for the QC Analyst, Microbiology include:
- Completion and maintenance of the disinfectant efficacy program
- Data review and trending to ensure integrity and adherence to standard operating procedures and cGMPs
- Provide support for swab recovery studies and cleaning validation.
- Laboratory sample receipt and tracking
- Packaging and sending samples to contract laboratories
- Compendial testing such as MLT, growth promotion, endotoxin, TOC and conductivity
- Equipment/instrument standardization and calibration, as required for testing per SOP’s
- Supports daily collection of utility and environmental samples, including water and steam sample collection
- Completion of GMP worksheets
- Coordinates and performs laboratory investigations
- Data entry into laboratory data system
- Maintain inventory of laboratory supplies
- Daily laboratory upkeep and maintenance
- Supports validation activities such as facility and utility qualification and autoclave load patterns
- This position performs routine microbial analysis of product samples
Requirements for the QC Analyst, Microbiology include:
- 0-3 years of experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment
- Execution of complex microbiological methods such as gram-staining, and microbial identification to species is preferred, but not required.
- Extensive experience performing USP testing such as MLT, growth promotion, endotoxin, TOC and conductivity is preferred, but not required.
- Strong aseptic technique experience is preferred, but not required.
- Advanced knowledge of cGMPs, safety, proper documentation, and data integrity is preferred, but not required.
- LIMS (Laboratory Information Management System) experience is preferred, but not required.
- Knowledge and application of GMP principles, and working in an FDA regulated environment
- Strong communication skills: oral/written and listening
- BS or BA in Microbiology, Biological sciences, or related fields experience