cGMP Associate III (A Team)

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Job Details

Job Summary

The GMP Associate III serves as an area expert across all manufacturing lines qualified and trained to operate every piece of equipment in the assigned area. This role builds upon the skills of GMP Associate I and II by providing technical leadership troubleshooting and guidance to less experienced associates. With a strong focus on safety quality and output the GMP Associate III is the go-to resource for GMP I and GMP II team members ensuring production goals are consistently met while maintaining compliance with all GMP GDP FDA ISO 13485 and safety requirements.

Key Responsibilities:

Safety

• Act as a role model for safe work practices and adherence to PPE standards.
• Support supervisors in identifying and mitigating safety risks on the floor.
• Provide guidance and reinforcement to GMP I and II associates on safe equipment operation.

Quality

• Uphold the highest standards of cleanroom discipline documentation and GMP compliance.
• Serve as a subject matter expert in GDP reviewing and supporting accurate completion of production and equipment records.
• Perform and verify in-process inspections to ensure product quality meets all specifications.

Manufacturing & Delivery

• Operate troubleshoot and maintain all equipment across the manufacturing area ensuring flexibility and reliability.
• Lead by example in loading/replenishing materials packaging and assembly tasks.
• Ensure consistent throughput by proactively resolving technical issues and minimizing downtime.
• Support and oversee TPM (Total Preventive Maintenance) activities ensuring proper execution and follow-up.

Leadership & Mentorship

• Act as the go-to resource for GMP I and GMP II associates technical questions troubleshooting and process guidance.
• Provide informal on-the-job training and coaching for team members.
• Collaborate closely with Production Supervisors Quality and Engineering to identify and implement improvements.

Continuous Improvement

• Drive lean initiatives including 5S Kaizen and problem-solving events.
• Contribute expertise in identifying root causes of issues and implementing sustainable solutions.
• Recommend process improvements to enhance safety efficiency and product quality.

Company Values

• Embody and reinforce company values in daily interactions.
• Foster a culture of teamwork accountability and continuous learning.
• Support production leadership by helping to set a professional and disciplined tone on the floor.
• Uphold company policies and procedures performing additional duties as needed to support production.
• Communicate effectively with supervisors and team members to resolve issues and ensure smooth production flow.

Qualifications

• High school diploma or equivalent required; technical certification or additional training preferred.
• 24 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.
• Comfortable working in a fast-paced team-driven environment.

Physical Requirements

• Stand for extended periods; perform repetitive tasks.
• Lift/move up to 25 lbs as needed.
• Wear cleanroom attire (gown mask gloves) for prolonged periods.

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