cGMP I, BMB - 3rd Shift

Haemonetics•Clinton, PA

About The Position

The GMP Associate I supports the manufacturing of high-quality medical devices by operating equipment, packing finished products, loading automatic hoppers, and resolving basic equipment faults through HMI (Human-Machine Interface) screens. This role requires adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and cleanroom standards while contributing to a safe, lean, and team-oriented environment.

Requirements

High school diploma or equivalent.
Ability to stand for long periods and perform repetitive tasks.
Willingness to wear full cleanroom PPE.

Nice To Haves

Prior manufacturing or production experience preferred.
Basic knowledge of HMI systems and cleanroom procedures a plus.
Strong attention to detail and commitment to quality.

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.
Stand for extended periods; perform repetitive tasks.
Lift/move up to 25 lbs as needed.
Wear cleanroom attire (gown, mask, gloves) for prolonged periods.