QC Analyst- Chemistry

Scientific Protein Laboratories•Waunakee, WI

9d•Onsite

About The Position

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a . This position is responsible for . Responsibilities include: 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.

Requirements

High School Diploma or G.E.D.
2+years

Nice To Haves

Bachelor's Degree or above in Microbiology or related discipline
5+ years

Responsibilities

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.