QC Metrology Supervisor
On-site · Bloomington, Indiana, United States
Job Summary
QC Metrology Supervisor leads the QC Metrology team and instrument-related activities within the quality program, overseeing instrument maintenance, calibration, and project execution to support cGMP manufacturing. Responsibilities include managing daily Metrology operations, enabling timely instrument support across QC/Production areas, developing and executing qualification protocols (IQ/OQ/PQ), maintaining SOPs, coordinating re-certifications with external labs, contributing to continuous improvement and Lean initiatives, supporting internal assessments and investigations, acting as SME for lab instruments and processes, participating in client and regulatory audits, ensuring data integrity, authoring Laboratory Investigation Reports, and leading projects involving new methods, instrumentation, and technologies. The role requires in-depth knowledge of biological and chemical assays, the ability to operate advanced lab equipment (HPLC, UV, Karl Fischer, pH meters), and familiarity with US/EU/JP pharmacopeias. The position reports to the Quality Control Chemistry Manager and includes opportunities for growth and a comprehensive benefits package.
Required Qualifications
- Bachelor's degree in a physical science related field
- Minimum of 5 years of experience with QC instruments
- Previous leadership experience preferred
- Proficiency with Microsoft Word, Excel, Outlook
- Knowledge of instrument repair and calibration systems
- Knowledge and navigation of QC documentation
- Ability to wear PPE
- Overtime work including nights and weekends
- Ability to stand or sit for long periods
- Ability to qualify for 20/40 vision
- Experience operating analytical instruments (HPLC, UV, Karl Fischer, pH meter)
- Experience in calibration, validation (IQ/OQ/PQ), SOPs, and data integrity
- Experience supporting audits and regulatory observations
- Strong analytical and problem-solving skills
- SME in lab instruments and processes
- Understanding of US and EU pharmacopeias (JP knowledge a plus)
- Experience with Lean/continuous improvement
- Knowledge of data integrity and compliance requirements
- Laboratory investigations and root-cause analysis
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