Senior GMP Equipment & Quality Lead

Haemonetics Corp; Pennsylvania; Presencial; USD 29.000 - 50.000; Jornada completa

Descripción de la vacante

Haemonetics Corp is seeking a GMP Associate III to serve as an area expert across manufacturing lines, providing technical leadership and troubleshooting. The role focuses on safety, quality, and output while ensuring compliance with GMP, GDP, FDA, ISO 13485, and safety requirements.

You will lead by example in training, mentor GMP I and II associates, and collaborate with Production Supervisors, Quality, and Engineering to drive improvements and lean initiatives on the floor.

Formación

• 2-4 years of experience in a GMP-regulated manufacturing environment (medical device, pharmaceutical, or biotech preferred).
• Fully qualified and trained on all equipment within the manufacturing area.
• Strong understanding of GMP, GDP, FDA, and ISO 13485 compliance standards.
• Demonstrated ability to troubleshoot and resolve complex equipment and process issues.
• Proven track record of mentoring, coaching, or providing guidance to peers.
• Excellent attention to detail, problem-solving, and communication skills.

Responsabilidades

• Act as a role model for safe work practices and PPE adherence.
• Provide guidance to GMP I and II associates on safe equipment operation.
• Maintain cleanroom discipline, documentation, and GMP compliance.
• Operate, troubleshoot, and maintain all equipment across the manufacturing area.
• Lead by example in loading/replenishing materials, packaging, and assembly tasks.
• Mentor team members and collaborate with Supervisors, Quality, and Engineering to drive improvements.

Conocimientos

GMP compliance

Equipment troubleshooting

Mentoring & coaching

Documentation accuracy

Safety focus

Lean / 5S

Educación

High school diploma or equivalent

Technical certification

Descripción del empleo

Haemonetics Corp is seeking a GMP Associate III to serve as an area expert across manufacturing lines, providing technical leadership and troubleshooting. The role focuses on safety, quality, and output while ensuring compliance with GMP, GDP, FDA, ISO 13485, and safety requirements.

You will lead by example in training, mentor GMP I and II associates, and collaborate with Production Supervisors, Quality, and Engineering to drive improvements and lean initiatives on the floor.