Scientific Protein Laboratories LLC (SPL) is a manufacturer of Active Pharmaceutical Ingredients (APIs) in the greater Madison, Wisconsin area. We currently have an exciting opportunity for an analyst experienced with qPCR analysis in the pharmaceutical industry. We are expanding our expertise in molecular technologies and this position will provide the opportunity for independent, creative thinking to support SPLs future vision.
We are looking for an individual who enjoys working in the laboratory. The QC Analyst will be responsible for performing complex routine analyses following written procedures. Further, experience with qPCR method development and optimization are a must as well as writing protocols, SOPs and methods to support new technologies and assays in the QC department.
- 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.
- Bachelor’s degree in Biology, Biotechnology, Microbiology, or related field
- 2+ years of PCR experience in a cGMP environment
- Experience with qPCR method development and optimization, as well as writing protocols, SOPs and methods. This includes driving process, designing primers and probes; troubleshooting; instrumentation
- Excellent oral and written communication skills
- Solid understanding of cGMP, GLP or other relevant regulations
- Analytical Skills; Attention to Detail; Decision Making; Flexibility; Initiative; Innovation; Interpersonal Skills; Listening; Oral Communication; Results Orientation; Time and Activity Management; Values Orientation; Written Communication
- The ability to work some extended hours may be necessary on occasion
SPL offers an excellent compensation and benefits package and a pleasant work environment.