Quality Control Analyst III, Raw Materials

Quality Control Analyst III, Raw Materials

This role conducts inspection, sampling, and testing of all raw materials and components used in the manufacturing process, ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). The analyst works independently with minimal supervision and collaborates with cross‑functional teams to resolve quality issues and achieve project goals.

• Perform compendial testing from USP and Ph.Eur on incoming raw materials.
• Perform testing of raw materials, initial, in‑process and final products, evaluating appearance, pH, conductivity, and osmolality.
• Work under minimum supervision, creating/revising SOPs, protocols and reports.
• Verify data entry completed by others.
• Assist with stability studies as directed, including removal of samples from stability chambers, aseptic aliquotation, labeling, and verification.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Perform maintenance and cleaning of laboratory equipment.
• Serve as a subject‑matter expert to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions.
• Update and track metrics for trending and reporting; record stability and QC analytical data.
• Initiate SOP changes to streamline, standardize, and improve quality system processes.
• Assist in training new hires and retraining QC laboratory staff as needed.
• Perform other duties as assigned.

• Bachelor's Degree in a Life Sciences discipline.
• Minimum 5+ years’ experience in a cGMP analytical laboratory environment.
• Strong analytical, detail‑oriented, self‑motivated, and multitasking abilities.
• Proficient with MS Outlook, Word, Excel, PowerPoint, and other electronic systems.
• Excellent communication and interpersonal skills.
• Self‑starting and motivated with excellent time‑management and organizational skills.
• Ability to adapt to change and collaborate with diverse groups of people.

The position is laboratory‑based, working with chemical reagents and analytical equipment. Normal office working conditions include computer, phone, files, fax, and copier. Personal protective equipment must be worn as required. Minimum travel is required. Work may involve weekend or off‑hours testing.

Frequent standing/walking, PPE as required. Must be able to lift and move objects up to 25 pounds. Work may be upright and stationary and/or standing for typical working hours.

$90,000 - $110,000

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law.