Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We have an immediate opening in Waunakee, WI (Madison area) for a Microbiology Analyst in our Quality Control department. The Analyst is responsible for performing 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 is responsible for the initiation and execution of independent analytical and systems improvement projects.
- 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 issues to management, both in own work and others in the lab.
- With minimal assistance from management, author, execute and interpret laboratory experiments, analytical method and instrument validation efforts as necessary.
- Train other analysts in overall laboratory processes/systems and in general and complex assays, as required.
- Oversee, interpret results and perform analytical investigations for OOS (Out-of-Specification) and atypical data. Assist in the gathering of evidence or results. Write summary reports detailing the investigation.
- In areas of ownership, coordinate with vendors and other analysts to perform routine calibration and preventive maintenance of laboratory equipment.
- Review/Revise SOPs and serve as a technical resource to ensure compliance with compendial documents.
- Review and interpret the work of other analysts.