GMP Senior Associate: Equipment Leader & Mentor

Haemonetics Software Solutions; Pennsylvania; On-site; USD 29,000 - 50,000; Full time

Job summary

Haemonetics is seeking a GMP Associate III in Pennsylvania to serve as an area expert across manufacturing lines. You will provide technical leadership, troubleshooting, and guidance to GMP I and II teams, ensuring safety, quality, and regulatory compliance across GMP, GDP, FDA, ISO 13485 standards.

The working schedule is 4x10-hour shifts (Thursday night into Monday morning), with opportunities for mentorship and process improvement in a fast-paced, team-driven environment.

Qualifications

• High school diploma or equivalent; technical certification preferred.
• 2–4 years 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.

Responsibilities

• Safety: Act as a role model for safe work practices and PPE adherence; support safety risk mitigation.
• Quality: Maintain cleanroom discipline, documentation, and GMP compliance; review production and equipment records.
• Manufacturing & Delivery: Operate, troubleshoot, and maintain equipment; ensure throughput and materials handling.
• Leadership & Mentorship: Provide on-the-job training and coaching to team members; collaborate with supervisors, Quality, and Engineering.
• Continuous Improvement: Drive lean initiatives (5S, Kaizen) and root-cause analysis for durable improvements.
• Company Values: Promote teamwork, accountability, and continuous learning across production.

Skills

Attention to detail

Problem-solving

Communication skills

Mentoring

Education

High school diploma or equivalent

Technical certification preferred

Job description

Haemonetics is seeking a GMP Associate III in Pennsylvania to serve as an area expert across manufacturing lines. You will provide technical leadership, troubleshooting, and guidance to GMP I and II teams, ensuring safety, quality, and regulatory compliance across GMP, GDP, FDA, ISO 13485 standards.

The working schedule is 4x10-hour shifts (Thursday night into Monday morning), with opportunities for mentorship and process improvement in a fast-paced, team-driven environment.