QA Lead, Sterile Manufacturing Floor

MannKind Corporation; Danbury (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

MannKind Corporation is seeking a Quality Assurance professional to provide independent oversight on the sterile manufacturing floor, ensuring GMP compliance and batch record integrity for commercial and clinical batches.

You will review batch records, support deviations and investigations, and ensure adherence to SOPs, data integrity, and aseptic processes while working with MNKD partners and cross-functional teams.

Qualifications

• BA/BS degree in a scientific or technical discipline with 4–6 years in QA, preferably sterile product manufacturing.
• Knowledge of GxP, ISO standards and FDA/EU regulations.
• Experience reviewing/writing change controls and document reviews for regulatory compliance is preferred.
• Strong GMP quality systems knowledge, risk management, and documentation.
• Aseptic processing, equipment/utility qualifications, clean rooms, and environmental monitoring knowledge preferred.
• Excellent written and verbal communication, and strong interpersonal skills.
• Ability to work independently with problem-solving and analytical skills.

Responsibilities

• Provide real-time quality oversight on sterile manufacturing and packaging operations.
• Interpret GMP, ISO 13485:2016 and relevant regulatory standards on the floor.
• Review Master Batch Records for compliance and support CAPAs, deviations, and investigations.
• Collaborate with MNKD partner on batch record questions, deviations, and SOPs.
• Lead line clearance, area clearance, and data integrity checks during operations.
• Support validation/qualification activities for equipment/systems/processes.

Skills

GxP Compliance

GMP quality systems

Regulatory knowledge

Problem solving

Independent work

Communication skills

Documentation

Education

BA/BS degree in science or related QA

Job description

MannKind Corporation is seeking a Quality Assurance professional to provide independent oversight on the sterile manufacturing floor, ensuring GMP compliance and batch record integrity for commercial and clinical batches.

You will review batch records, support deviations and investigations, and ensure adherence to SOPs, data integrity, and aseptic processes while working with MNKD partners and cross-functional teams.