cGMP Associate III (Manual Line)

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

Job summary

Haemonetics is seeking a GMP Associate III to serve as an area expert across manufacturing lines, qualified to operate every piece of equipment in the assigned area. This role provides technical leadership, troubleshooting, and guidance to less experienced associates with a strong focus on safety, quality, and output to ensure compliance with GMP, GDP, FDA, ISO 13485, and safety requirements.

The GMP Associate III acts as the go-to resource for GMP I and II, mentoring teammates, leading by

Qualifications

• 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.

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.

Skills

GMP knowledge

Manufacturing experience

Troubleshooting

Documentation

Communication skills

Education

High school diploma or equivalent

Tools

Equipment operation

TPM knowledge

5S/Kaizen

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

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.
• 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.

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.

Pay Transparency

The pay range for this role is:

$21.15-$35.95/Hourly

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles.

Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, flexible time off for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email [e-mail].