Job Title: GMP Associate I (Light Industrial)
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)
Position Summary: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.
Key Responsibilities:1. Safety- Follow all safety procedures and wear required PPE at all times.
- Report hazards, equipment malfunctions, and incidents promptly.
2. Quality & Compliance- 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.
3. Manufacturing Operations- 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.
4. Continuous Improvement- Participate in Lean initiatives such as 5S, Kaizen, and QEK.
- Complete required Lean training programs for associate-level roles.
5. Team Collaboration & Company Values- Work closely with Quality, Engineering, and Production teams to meet goals.
- Maintain professionalism and adhere to company policies and values.
Qualifications:- 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.
Physical Requirements:- 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.
Additional Notes:- Candidates must be comfortable working in a cleanroom environment.
- Strong adherence to compliance and documentation standards is essential.