GMP Night Shift Area Lead - Bottling Operations

Haemonetics Corp; Pennsylvania; On-site; USD 33,000 - 56,000; Full time

Job summary

Haemonetics Corp is seeking a GMP Area Leader for manufacturing operations. You will direct daily work across lines, lead associates, and ensure safety, quality, and efficiency while upholding GMP, GDP, FDA, and ISO standards.

You will support onboarding, cross-training, and continuous improvement initiatives, fostering accountability, teamwork, and a culture of safety. This role emphasizes leadership, problem-solving, and reliable production performance.

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.

Responsibilities

• Leadership & Workforce Direction: Assign and direct daily work across manufacturing lines to ensure safety, quality, and output goals are achieved.
• Leadership & Workforce Direction: Prioritize production activities in alignment with schedules and supervisor guidance.
• Leadership & Workforce Direction: Monitor associate performance, provide coaching and feedback, and escalate concerns when needed.
• Leadership & Workforce Direction: Support supervisors in extending disciplinary actions, ensuring fairness and consistency.
• Leadership & Workforce Direction: Act as the first point of contact for questions, concerns, and escalations from GMP I, II, III, and Trainers.
• Leadership & Workforce Direction: Create rotations and balance shift workload.
• Safety: Champion a strong safety culture, ensuring proper use of PPE and adherence to all procedures.
• Safety: Identify and mitigate risks, escalating safety concerns promptly.
• Safety: Reinforce safe machine operation and cleanroom discipline across the team.
• Quality & Compliance: Ensure all associates adhere to GMP, GDP, FDA, and ISO 13485 standards.
• Quality & Compliance: Oversee accurate completion of production and equipment documentation.
• Quality & Compliance: Verify in-process inspections and final outputs meet quality specifications.
• Quality & Compliance: Promote accountability for cleanroom discipline, documentation accuracy, and compliance.
• Manufacturing & Delivery: Lead associates in operating and troubleshooting equipment, ensuring minimal downtime.
• Manufacturing & Delivery: Oversee material handling, packaging, assembly, and preventive maintenance (TPM) activities.
• Manufacturing & Delivery: Ensure cross-trained associates are effectively deployed to meet production needs.
• Manufacturing & Delivery: 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.
• Training & Development: Maintain visibility of cross-training matrices and skill gaps across the area.
• Training & Development: 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.
• Continuous Improvement: Collaborate with supervisors, quality, and engineering to identify and implement process improvements.
• Continuous Improvement: Encourage team members to contribute ideas to enhance safety, efficiency, and quality.
• Company Values & Culture: Model professionalism, accountability, and respect in all interactions.
• Company Values & Culture: Promote teamwork, communication, and trust within the area.
• Company Values & Culture: Uphold company policies and act as a role model for values-driven behavior.
• Company Values & Culture: Uphold company policies and procedures, performing additional duties as needed to support production.
• Company Values & Culture: Communicate effectively with supervisors and team members to resolve issues and ensure smooth production flow.

Skills

Leadership

GMP I-III

Lean manufacturing

Safety

Coaching/mentoring

Education

High school diploma or equivalent

Job description

Haemonetics Corp is seeking a GMP Area Leader for manufacturing operations. You will direct daily work across lines, lead associates, and ensure safety, quality, and efficiency while upholding GMP, GDP, FDA, and ISO standards.

You will support onboarding, cross-training, and continuous improvement initiatives, fostering accountability, teamwork, and a culture of safety. This role emphasizes leadership, problem-solving, and reliable production performance.