GMP Area Lead Bottling Night Shift

Haemonetics Software Solutions; Pennsylvania; On-site; USD 33,000 - 55,000; Full time

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Flexible time off

Paid vacation and sick time

Job summary

Haemonetics Software Solutions is hiring a GMP Area Leader to direct daily manufacturing activities, ensure safety and quality, and drive continuous improvement across lines. You will coach associates, enforce standards, and coordinate with supervisors to maintain production flow in a GMP environment.

Expect responsibilities in lean initiatives, training, and cross-training, with emphasis on documentation, compliance, and teamwork to meet regulatory and quality targets.

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.

Responsibilities

• Assign and direct daily work across manufacturing lines to ensure safety, quality, and output goals.
• Prioritize production activities in alignment with schedules and supervisor guidance.
• Monitor associate performance, provide coaching and feedback, and address concerns.
• 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.
• Champion a strong safety culture and ensure proper PPE use.
• Identify and mitigate risks, escalate safety concerns promptly.
• Oversee documentation and ensure compliance with standards.
• Lead troubleshooting and cross-trained deployment to meet production needs.
• Provide onboarding and ongoing training in GMP, GDP, safety and equipment operation.
• Drive lean initiatives like 5S, Kaizen, and structured problem-solving.
• Promote teamwork and continuous improvement across the area.

Skills

Leadership

Safety management

Quality & compliance

Manufacturing operations

Training & development

Continuous improvement

Communication skills

Education

High school diploma or equivalent

Job description

Pay Transparency

Pay range for this role is: $23.80-$40.40/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]. 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 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.

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 escape 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

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals. We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.