Senior GMP Associate - Equipment & Process Leader

Haemonetics Interventional Technologies; Pennsylvania, United States, Northern America, Americas; Hybrid; USD 29,000 - 50,000; Full time

Benefits offered by this job

401(k) with employer match

Paid time off

Health and welfare benefits

Job summary

Haemonetics is seeking a GMP Associate III to act as a subject matter expert across the manual line. You will operate, troubleshoot, and maintain all equipment in the manufacturing area while ensuring GMP, GDP, FDA and ISO 13485 compliance.

The role emphasizes safety, quality, and continuous improvement, with mentorship to GMP I/II staff and collaboration with Production, Quality and Engineering teams.

Qualifications

• High school diploma or equivalent required, technical certs preferred.
• 2–4 years in GMP-regulated manufacturing (medical device/pharma/biotech preferred).
• Fully qualified on all equipment within the manufacturing area.
• Strong understanding of GMP, GDP, FDA and ISO 13485 compliance.
• Proven troubleshooting, mentoring and peer guidance skills.

Responsibilities

• Operate, troubleshoot and maintain equipment across the manufacturing area.
• Lead lean activities and drive improvements for safety and quality.
• Provide informal on‑the‑job training to GMP I/II teammates.
• Support TPM activities and coordinate with QA, Eng, and Supervisors.
• Maintain cleanroom discipline and accurate production records.

Skills

GMP compliance

Troubleshooting

Mentoring

Documentation

Lean manufacturing

Education

High school diploma or equivalent

Technical certification preferred

Tools

Equipment operation

Job description

Haemonetics is seeking a GMP Associate III to act as a subject matter expert across the manual line. You will operate, troubleshoot, and maintain all equipment in the manufacturing area while ensuring GMP, GDP, FDA and ISO 13485 compliance.

The role emphasizes safety, quality, and continuous improvement, with mentorship to GMP I/II staff and collaboration with Production, Quality and Engineering teams.