Job Title: GMP Associate
Location: Clinton, PA 15026 (Onsite)
Duration: 6-Month Contract
Shift: 6:30 PM – 6:45 AM (2-2-3 Schedule)
Job Summary
We are seeking a GMP Associate to join our manufacturing team in Clinton, PA. The ideal candidate will support the production of high-quality medical devices by operating manufacturing equipment, performing packaging activities, maintaining GMP documentation, and ensuring compliance with quality and cleanroom standards. This role requires attention to detail, adherence to Good Manufacturing Practices (GMP), and the ability to work effectively in a fast-paced manufacturing environment.
Key Responsibilities
Safety
- Follow all workplace safety procedures and wear required Personal Protective Equipment (PPE).
- Identify and report safety hazards, equipment malfunctions, and workplace incidents promptly.
- Maintain a safe, clean, and organized work environment.
Quality & Compliance
- Follow Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA regulations, and ISO 13485 quality standards.
- Comply with cleanroom procedures, including gowning and contamination control requirements.
- Complete batch records, production logs, and other manufacturing documentation accurately.
- Perform in-process quality inspections and report deviations as required.
Manufacturing Operations
- Operate manufacturing and production equipment according to standard operating procedures.
- Load automatic hoppers and monitor material levels to ensure uninterrupted production.
- Assemble medical device components and subassemblies following work instructions.
- Package finished products and complete all required production documentation.
- Troubleshoot basic equipment issues using Human-Machine Interface (HMI) screens and escalate complex issues when necessary.
- Perform routine cleaning and sanitization of equipment and workstations.
Continuous Improvement
- Participate in Lean Manufacturing initiatives, including 5S, Kaizen, and Quality Excellence programs.
- Support process improvements to enhance safety, quality, and operational efficiency.
- Complete required Lean Manufacturing training.
Teamwork & Professionalism
- Collaborate effectively with Manufacturing, Quality, Engineering, and Operations teams.
- Demonstrate a positive attitude, accountability, and commitment to company values.
- Support production goals while maintaining high quality and compliance standards.
Required Qualifications
- High school diploma or GED required.
- Previous manufacturing experience preferred; medical device, pharmaceutical, or regulated manufacturing experience is a plus.
- Basic mechanical aptitude and ability to operate manufacturing equipment.
- Ability to understand and follow Standard Operating Procedures (SOPs) and work instructions.
- Strong attention to detail and documentation accuracy.
- Ability to work effectively in a team-oriented environment.
- Basic computer skills and ability to navigate HMI screens.
Physical Requirements
- Ability to stand and walk for extended periods.
- Perform repetitive tasks throughout the shift.
- Lift and move up to 25 lbs as needed.
- Ability to work in a cleanroom environment while wearing required gowning, gloves, masks, and other PPE for extended periods.
Preferred Skills
- Experience working in a GMP-regulated manufacturing environment.
- Knowledge of FDA regulations, ISO 13485, and GDP documentation practices.
- Familiarity with Lean Manufacturing, 5S, or Kaizen principles.
- Experience with medical device manufacturing or assembly.
If you are a dependable and detail-oriented manufacturing professional looking to build your career in the medical device industry, we encourage you to apply!
Company Description
Fusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.
Fusion provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and FDA Remediation.
We exist to become the finest and most esteemed staffing company across USA, and we look forward to putting our talents to use to push your organization forward.