GMP Manufacturing Associate I — Cleanroom & Lean Ops

Haemonetics Software Solutions; Pennsylvania; On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

401(k) with employer match

Tuition reimbursement

Paid time off and health benefits

Job summary

Haemonetics is seeking an GMP Associate I in Pennsylvania to support the manufacturing of medical devices. You will operate equipment, pack finished products, load hoppers, and resolve basic equipment faults via HMI screens.

You will work under GMP, GDP, and cleanroom standards in a safe, lean, and team-oriented environment. The role emphasizes adherence to quality documentation, in-process checks, and continuous improvement through lean initiatives.

Qualifications

• High school diploma or equivalent.
• Prior manufacturing or production experience preferred.
• Basic knowledge of HMI systems and cleanroom procedures a plus.
• Strong attention to detail and commitment to quality.
• Ability to stand for long periods and perform repetitive tasks.
• Willingness to wear full cleanroom PPE.

Responsibilities

• Follow all safety procedures, including the proper use of PPE.
• Report hazards, malfunctions, and incidents promptly.
• Adhere to cleanroom protocols and gowning requirements.
• Maintain accurate, compliant documentation (batch records, logs, GDP).
• Perform in-process checks and follow GMP, FDA, and ISO 13485 standards.
• Load hoppers and monitor material levels to avoid interruptions.
• Assemble components and subassemblies per work instructions.
• Execute activities in molding such as proper packaging and completion of GDP paperwork.
• Operate production equipment and resolve basic HMI faults, escalating as needed.
• Perform routine cleaning and sanitization of equipment and workspace.
• Participate in lean initiatives (5S, Kaizen, QEK).
• Complete required lean curriculum for associate level.
• Collaborate with Quality, Engineering, and other teams to achieve production goals.
• Uphold company values and policies with professionalism.

Skills

Attention to detail

GMP/GDP knowledge

Cleanroom procedures

PPE usage

Basic manufacturing experience

HMI systems familiarity

Education

High school diploma or equivalent

Tools

HMI systems

Job description

Haemonetics is seeking an GMP Associate I in Pennsylvania to support the manufacturing of medical devices. You will operate equipment, pack finished products, load hoppers, and resolve basic equipment faults via HMI screens.

You will work under GMP, GDP, and cleanroom standards in a safe, lean, and team-oriented environment. The role emphasizes adherence to quality documentation, in-process checks, and continuous improvement through lean initiatives.