Scientific Protein Laboratories LLC (SPL) is a manufacturer of Active Pharmaceutical Ingredients (APIs) in the greater Madison, Wisconsin area. We currently have a temporary opportunity for an analyst experienced with microbiological testing in the pharmaceutical industry. We are a growing innovative company and this position will provide the opportunity for independent, creative thinking to support SPL's vision. The analyst will be responsible for performing routine microbiological tests following written procedures in accordance with USP.
The ideal candidate will have a degree in Biology, Biotechnology, Microbiology or a related field. A minimum of four years practical experience is required with a solid understanding of cGMP, GLP or other relevant regulations. Strong written and oral communication skills are a must for the candidate.
The Microbiology Analyst is responsible for performing simple and complex routine laboratory analyses on APIs following strict written procedures derived from the United States Pharmacopoeia and/or other documents, to meet strict compendial and custom specifications. This work is performed under the cGMP/FDA guidelines. This role participates in analytical and systems-improvement projects.
Follow Standard Operating Procedures (SOPs) to obtain accurate results.
Perform the scheduled laboratory testing of raw material, in-process, finished product APIs and special products.
Properly record all data results on appropriate documents and in electronic files, including immediate communication of problems to management.
With assistance from management, author and/or execute laboratory experiments, analytical method and instrument validation efforts as necessary.
Perform routine calibration and preventive maintenance of laboratory equipment.
Review/Revise SOPs to ensure compliance with compendial documents.
Review and interpret the work of other analysts.
Bachelor's Degree in Biology, Biotechnology, Microbiology, or related field
At least 4 years of practical experience
SPL offers competitive compensation including holiday pay, and a pleasant work environment.