Associate QC Analyst

Job Details:

Job Location:

Scientific Protein Laboratories
- Waunakee, WI 53597, 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.

The Associate Quality Control Analyst
- Chemistry is an entry-level laboratory position responsible for performing routine chemical and analytical testing of raw materials, in-process samples, and Active Pharmaceutical Ingredients (APIs) in a cGMP-regulated environment. Testing is performed according to approved Standard Operating Procedures (SOPs), test methods, compendial requirements, specifications, and other controlled documents. The position supports accurate and timely product testing while maintaining complete documentation, laboratory readiness, and compliance with applicable quality and safety requirements.

• Perform routine QC chemistry testing of raw materials, in-process samples, finished APIs, and other assigned samples according to approved methods, specifications, and laboratory procedures.
• Perform sample preparation and analytical testing using techniques and equipment appropriate to assigned methods, which may include HPLC, GC, UV/Visible spectrophotometry, pH, moisture/LOD, and other wet-chemistry or compendial techniques.
• Follow SOPs, test methods, specifications, cGMP requirements, Good Documentation Practices (GDP), data-integrity expectations, and laboratory safety procedures.
• Record laboratory activities and test results accurately, completely, and contemporaneously in controlled records and approved electronic systems, including laboratory information and chromatography data systems as applicable.
• Evaluate results against established acceptance criteria and promptly communicate unexpected, atypical, out-of-specification/out-of-trend, procedural, or equipment-related issues to laboratory management.
• Prepare, label, document, store, and maintain reagents, solutions, mobile phases, standards, and other laboratory materials as assigned; monitor inventory and expiration status and communicate supply needs.
• Perform routine instrument checks, calibrations, preventive maintenance, cleaning, and basic troubleshooting as trained and assigned; maintain required equipment and logbook documentation.
• Maintain laboratory work areas, shared equipment, glassware, and storage areas in a clean, organized, safe, and inspection-ready condition; assist with laboratory waste and sample disposal according to procedure.
• Perform basic peer review of laboratory records, calculations, and analytical data after appropriate training and qualification and as assigned.
• Complete required training and method qualifications and maintain assigned laboratory qualifications.
• Assist, under direction, with approved laboratory studies, method or instrument validation/verification activities, investigations, change-related work, and other QC improvement activities.
• Read and provide input on SOPs, test methods, forms, and other controlled laboratory documents as assigned.
• Organize and prioritize assigned work to support laboratory schedules, manufacturing needs, and required testing turnaround times.
• Work cooperatively with QC colleagues and other departments and communicate testing status, issues, and handoffs clearly and professionally.
• Perform other duties consistent with the responsibilities of the position as assigned.

• High…