QC Metrology Supervisor

Responsibilities

• Manage daily activities of the QC Metrology department and analysts
• Ensure timely metrology support to Production, QC Chemistry, Microbiology, and other cGMP areas
• Manage new instrument projects including installation and qualification (IQ/OQ/PQ)
• Calibrate analytical instruments to government and commercial standards
• Write, revise, and review Standard Operating Procedures (SOPs)
• Participate in continuous improvement and Lean initiatives
• Perform internal assessments and investigations regarding risks
• Serve as a technical Subject Matter Expert (SME) for lab instruments and processes
• Ensure data integrity requirements are maintained
• Author Laboratory Investigation Reports

Requirements

• Bachelor’s degree in a physical science related field
• Minimum of 5 years of experience with QC instruments
• Knowledge of instrument, software, and documentation repair and calibration systems
• Proficiency in Microsoft Word, Excel, and Outlook
• Ability to navigate QC documentation

Preferred Qualifications

• Previous leadership experience
• Experience operating advanced laboratory equipment such as HPLC, UV, Karl Fischer, and pH meters
• Thorough knowledge of US, EU, and JP pharmacopeias

Benefits

• Medical and Dental coverage
• 401(k) with company match
• Paid Time Off and Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Ownership Plan
• Onsite amenities including a workout facility and cafeteria

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.