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Job Details

Job Summary

The GMP Area Leader serves as the frontline leader within manufacturing operations, responsible for directing daily work, leading associates, and ensuring production targets are met safely, compliantly, and efficiently. Building on the technical expertise of GMP I–III and the coaching skills of the GMP Trainer, this role combines deep process knowledge with strong leadership capabilities. The GMP Area Leader prioritizes tasks, escalates issues as needed, enforces discipline, and fosters a culture of accountability, teamwork, and continuous improvement.

D Shift 2-2-3 - 12 hr Night shift Schedule

Key Responsibilities:

Leadership & Workforce Direction:

• Assign and direct daily work across manufacturing lines to ensure safety, quality, and output goals are achieved.
• Prioritize production activities in alignment with schedules and supervisor guidance.
• Monitor associate performance, provide coaching and feedback, and escalate concerns when needed.
• Support supervisors in extending disciplinary actions, ensuring fairness and consistency.
• Act as the first point of contact for questions, concerns, and escalations from GMP I, II, III, and Trainers.
• Create rotations and balance shift workload

Safety:

• Champion a strong safety culture, ensuring proper use of PPE and adherence to all procedures.
• Identify and mitigate risks, escalating safety concerns promptly.
• Reinforce safe machine operation and cleanroom discipline across the team.

Quality & Compliance

• Ensure all associates adhere to GMP, GDP, FDA, and ISO 13485 standards.
• Oversee accurate completion of production and equipment documentation.
• Verify in-process inspections and final outputs meet quality specifications.
• Promote accountability for cleanroom discipline, documentation accuracy, and compliance.

Manufacturing & Delivery

• Lead associates in operating and troubleshooting equipment, ensuring minimal downtime.
• Oversee material handling, packaging, assembly, and preventive maintenance (TPM) activities.
• Ensure cross-trained associates are effectively deployed to meet production needs.
• Escalate complex technical or equipment issues to maintenance, engineering, or supervisors.

Training & Development

• Support onboarding and ongoing training in GMP, GDP, safety, and equipment operation.
• Maintain visibility of cross-training matrices and skill gaps across the area.
• Act as a mentor, reinforcing technical, quality, and soft skills for GMP I–III associates.

Continuous Improvement

• Drive lean initiatives such as 5S, Kaizen, and structured problem-solving.
• Collaborate with supervisors, quality, and engineering to identify and implement process improvements.
• Encourage team members to contribute ideas to enhance safety, efficiency, and quality.

Company Values & Culture

• Model professionalism, accountability, and respect in all interactions.
• Promote teamwork, communication, and trust within the area.
• Uphold company policies and act as a role model for values-driven behavior.
• 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; advanced training, certification, or leadership coursework preferred.
• 3–5 years of experience in a GMP-regulated manufacturing environment (medical device, pharmaceutical, or biotech preferred).
• Proven ability to lead teams, assign work, and enforce accountability.
• Strong knowledge of GMP, GDP, FDA, and ISO 13485 standards.
• Demonstrated expertise across all manufacturing equipment and processes.
• Experience coaching, mentoring, or training associates.
• Excellent organizational, communication, and interpersonal skills.
• Ability to balance technical problem-solving with people leadership.

Physical Requirements

• Stand for extended periods; oversee hands-on production activities.
• Lift/move up to 25 lbs as needed.
• Wear cleanroom attire (gown, mask, gloves) for prolonged periods.

EEO Policy Statement

Pay Transparency:

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 AskHR@Haemonetics.com.

The base salary range for this role is: