Senior QA Specialist – Sterile Manufacturing & Compliance

MannKind Corporation; Danbury (CT); Sur place; USD 95 000 - 120 000; Plein temps

Résumé du poste

MannKind Corporation is seeking a Quality Assurance professional to provide independent oversight on the sterile manufacturing floor, ensuring GMP/ISO compliance and support for batch records and quality systems.

You will review records, participate in deviations and CAPAs, and help maintain data integrity and product quality across commercial and clinical batches. Strong communication and problem-solving are essential.

Qualifications

• BA/BS degree in a scientific or technical field.
• 4–6 years QA experience, preferably in sterile manufacturing.
• Knowledge of GMP, ISO, FDA/EU regulations.
• Experience reviewing change controls and document reviews.
• Strong written and verbal communication.

Responsabilités

• Provide QA oversight on sterile manufacturing floor for commercial and clinical batches.
• Interpret GMP, ISO 13485, and regulatory standards.
• Review Master Batch Records for compliance and investigate issues.
• Support CAPAs, deviations, change controls, and risk assessments.
• Provide real-time QA decision making during manufacturing events.
• Ensure adherence to SOPs and data integrity.

Connaissances

GxP Compliance

Regulatory Knowledge

Quality Assurance

Deviation Handling

Formation

BA/BS degree

Outils

Change Controls

Documentation Review

Manufacturing Oversight

Description du poste

MannKind Corporation is seeking a Quality Assurance professional to provide independent oversight on the sterile manufacturing floor, ensuring GMP/ISO compliance and support for batch records and quality systems.

You will review records, participate in deviations and CAPAs, and help maintain data integrity and product quality across commercial and clinical batches. Strong communication and problem-solving are essential.