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 SPL's future vision.
The QC Analyst will be responsible for performing complex routine laboratory analyses following written procedures. Experience with qPCR method development and optimization is required, and writing protocols, SOPs and methods are a must. This work is performed under the cGMP/FDA guidelines. The QC Analyst also initiates and executes 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.
The position requires a minimum of a four-year degree in in Biology, Biotechnology, Microbiology, or related field
Excellent oral and writing skills
Must have at least 2 years of qPCR experience in a pharmaceutical manufacturing setting
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