GMP Associate I

Location: Clinton PA USA
Shift: 2-2-3 Schedule (Night Shift)
Hours: 6:45 PM 6:30 AM (12-hour shifts)

Hiring Manager: Darrell Hamm (Onsite)

The GMP Associate I plays a key role in supporting the manufacturing of high-quality medical devices. This position involves operating production equipment packaging finished goods loading materials into automated systems and troubleshooting basic equipment issues through HMI (Human-Machine Interface).

The ideal candidate will strictly adhere to Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) and cleanroom standards while maintaining a safe efficient and team-oriented work environment.

• Follow all safety procedures and wear required PPE at all times.
• Report hazards equipment malfunctions and incidents promptly.

• Adhere to cleanroom protocols including gowning requirements.
• Maintain accurate and compliant documentation (batch records logs GDP).
• Perform in-process quality checks.
• Ensure compliance with GMP FDA and ISO 13485 standards.

• Load hoppers and monitor material levels to prevent production interruptions.
• Assemble components and subassemblies as per work instructions.
• Perform molding-related tasks including packaging and documentation.
• Operate production equipment and troubleshoot basic issues via HMI; escalate when necessary.
• Conduct routine cleaning and sanitization of equipment and workspace.

• Participate in Lean initiatives such as 5S Kaizen and QEK.
• Complete required Lean training programs for associate-level roles.

• Work closely with Quality Engineering and Production teams to meet goals.
• Maintain professionalism and adhere to company policies and values.

• High school diploma or equivalent required.
• Prior experience in manufacturing or production environment preferred.
• Basic understanding of HMI systems and cleanroom procedures is a plus.
• Strong attention to detail and commitment to quality.
• Ability to follow instructions and work in a regulated environment.

• Ability to stand for extended periods.
• Perform repetitive tasks consistently.
• Lift/move up to 25 lbs as needed.
• Wear full cleanroom attire (gown mask gloves) for extended durations.

• Candidates must be comfortable working in a cleanroom environment.
• Strong adherence to compliance and documentation standards is essential.