Quality Person In Plant (Morris County)

A large pharmaceutical manufacturer is seeking a Quality Person In Plant to join their growing External Quality team within Advanced Therapeutics . This role provides on-site Quality oversight of the analytical space, ensuring compliance with cGMP and FDA regulations. Ideal candidates will bring a strong background in drug substance manufacturing , analytical methods , and quality systems .

Key Responsibilities

• Review and approve nonconformances , deviations , and out-of-specification results
• Act as liaison for change control review, approval, and implementation
• Monitor Environmental Monitoring (EM) quality performance and proactively identify risks
• Build and influence relationships with internal and external partners to enhance quality performance
• Collaborate cross-functionally with Operations , Planning , Technical Operations , and external manufacturers
• Apply cGMP , FDA , and international regulatory requirements to all aspects of the role
• Provide on-site support as needed at the request of the team lead

Required Skills & Experience

Preferred Skills