GMP Associate

Summary:
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.

Key Responsibilities

1. Safety
Follow all safety procedures including the proper use of PPE.
Report hazards malfunctions and incidents promptly.

2. Quality
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.

3. Manufacturing & Delivery
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.

4. Continuous Improvement
Participate in lean initiatives (5S Kaizen QEK).
Complete required lean curriculum for associate level.

5. Company Values
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.

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.

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