Quality Investigator

Patients depend on every lot leaving the plant exactly as intended. You will turn unexpected events into clear, defensible conclusions—so the right product ships, the wrong product does not, and the science behind each therapy stays trustworthy. This role exists to protect patients by making quality decisions faster, sharper, and harder to second-guess.

Performance Objectives

• Lead investigations of deviations, complaints, and out-of-specification results to a documented root cause and batch disposition within defined timelines.
• Quantify product, process, and patient impact so release, rejection, or rework decisions rest on evidence, not opinion.
• Drive corrective and preventive actions that close the failure mode and show sustained effectiveness on subsequent lots.
• Write investigation reports that stand up to internal quality review and external inspection without rework.
• Spot repeat signals across sites, products, and suppliers and convert them into prioritized risk reductions.
• Coach manufacturing, labs, and engineering so facts are captured the first time and investigations start with a complete record.
• Keep the quality system inspection-ready: traceable data, closed loops, and no open critical findings on your cases.

Environment & Resources

You sit in Quality, partner daily with manufacturing, QC, validation, and supply, and escalate risk to Quality leadership. You work inside a validated electronic quality system, with access to batch records, lab data, change history, and cross-functional subject-matter experts. Investigations are staffed to finish, not to linger.

Essential Qualifications

• Proven ownership of GMP investigations through root cause, impact assessment, and approved CAPA.
• Ability to read process, analytical, and batch data and separate signal from noise.
• Writing that is precise, factual, and inspection-ready.
• Working command of GMP, data integrity, and deviation/CAPA expectations in biologics or human therapeutics.
• Track record of closing repeat issues, not just documenting them.
• Bachelor’s degree in a science or engineering field, or equivalent investigation experience in regulated manufacturing.

Role Selling Points

• Your conclusions decide whether a therapy reaches a patient.
• Science-first culture: evidence over hierarchy.
• Breadth across biologics development and commercial manufacturing.
• Peers who treat quality, ethics, and teamwork as operating standards, not slogans.

Call to Action

If you can find the real cause, defend the decision, and stop the next failure, apply. Bring one investigation you closed that still holds up.