cGMP Associate III (A Team) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Haemonetics · 1 week ago

cGMP Associate III (A Team)

Haemonetics is a company focused on providing a diverse and dynamic work environment. The GMP Associate III serves as an area expert across all manufacturing lines, providing technical leadership and guidance while ensuring compliance with safety and quality standards.

BiotechnologyConsultingHealth CareMedicalMedical Device
check
H1B Sponsor Likelynote

Responsibilities

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
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
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
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
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
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

Qualification

GMP complianceGMP-regulated manufacturingEquipment troubleshootingTechnical certificationLean initiativesMentoringCommunication skillsAttention to detail

Required

High school diploma or equivalent required; technical certification or additional training preferred
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
Comfortable working in a fast-paced, team-driven environment
Stand for extended periods; perform repetitive tasks
Lift/move up to 25 lbs as needed
Wear cleanroom attire (gown, mask, gloves) for prolonged periods

Preferred

Technical certification or additional training

Company

Haemonetics

company-logo
Haemonetics is a global medical technology company that provides Blood Management and Interventional Technologies.

H1B Sponsorship

Haemonetics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (3)
2022 (2)
2021 (4)

Funding

Current Stage
Public Company
Total Funding
$1.75B
2024-05-21Post Ipo Debt· $600M
2021-03-01Post Ipo Equity· $435M
2019-05-23Post Ipo Equity· $10M

Leadership Team

leader-logo
Christopher Simon
President and Chief Executive Officer
linkedin
leader-logo
Christopher Lindop
CFO and VP Business Development
linkedin
Company data provided by crunchbase