GMP Associate I

Location: Clinton PA USA
Work Type: Onsite
Duration: May 21 2026 November 20 2026

The GMP Associate I supports the manufacturing of high-quality medical devices by operating production equipment assembling and packaging products and ensuring compliance with regulatory and quality standards. This role requires strict adherence to Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) and cleanroom protocols while contributing to a safe and efficient production environment.

• Follow all safety procedures and properly use personal protective equipment (PPE).
• Report hazards equipment malfunctions and incidents in a timely manner.

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

• Load automatic hoppers and monitor material levels to prevent production interruptions.
• Assemble components and subassemblies following approved work instructions.
• Execute molding-related tasks including packaging and documentation completion.
• Operate production equipment and troubleshoot basic issues using HMI (Human-Machine Interface); escalate complex issues as needed.
• Perform routine cleaning and sanitization of equipment and work areas.

• Participate in lean manufacturing initiatives such as 5S Kaizen and QEK programs.
• Complete required lean training and contribute to process improvement efforts.

• Collaborate with Quality Engineering and cross-functional teams to meet production targets.
• Uphold company policies values and professional standards.

• High school diploma or equivalent required.
• Prior experience in manufacturing production or a cleanroom environment preferred.
• Basic knowledge of HMI systems and cleanroom procedures is a plus.
• Strong attention to detail and commitment to quality and compliance.
• Ability to work effectively in a team-oriented environment.

• Ability to stand for extended periods and perform repetitive tasks.
• Capability to lift and move up to 25 lbs as needed.
• Willingness to wear full cleanroom attire (gown mask gloves) for prolonged periods.