Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of pancreatic enzymes and heparin. We have an immediate opening for a Lead Quality Systems Specialistlocated at our Waunakee, WI (Madison area) facility. This position is responsible for assuring SPL maintains a strong quality system by ensuring deadlines are met, tasks are completed accurately the first time and mistakes have appropriate corrective and preventative actions put in place, so they are not repeated. The QS Specialist follows and maintains SPL’s procedures designed to ensure current Good Manufacturing Practice (cGMP) compliance, monitors quality training initiatives across the company, and prepares and maintains trend reports. Duties and Responsibilities:
Assists in drafting, reviewing and closing Deviations, CAPAs, and Change Controls.
Assists in preparation of the APR's.
Assists in preparation and review of procedures (SOPs, TMs, EIs, etc.) and batch documentation (MI's, RoA's, specifications, etc.) covering multiple Quality operations.
Develops and delivers training programs for all employees.
Assists in customer/regulatory agency audits.
Tracks and trends metrics for the Quality Systems Department.
Assists with external audits (i.e., customers, FDA). Job Standards: Education: Minimum of a Bachelor of Science degree (Chemistry, Microbiology or Biology) or closely related scientific discipline is required. Experience:
Between 5 and 10 years required SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.