Job Summary
We are seeking a detail-oriented Production Operator to support manufacturing operations involving the assembly, packaging, and labeling of medical devices and pharmaceutical products. The ideal candidate will follow established procedures, maintain quality standards, and ensure compliance with Good Manufacturing Practices (GMP) in a controlled manufacturing environment.
Key Responsibilities
- Perform assembly, packaging, and labeling of medical devices and pharmaceutical products.
- Operate manufacturing equipment according to standard operating procedures (SOPs) and work instructions.
- Conduct in-process and final visual inspections to ensure product quality.
- Complete production logs, batch records, and other required documentation accurately.
- Meet daily production targets and report downtime, scrap, and production issues.
- Verify material availability before starting production activities.
- Identify, segregate, and handle non-conforming materials according to established procedures.
- Maintain a clean, organized, and safe work environment in accordance with 5S and cleanroom standards.
- Follow all safety guidelines and wear required personal protective equipment (PPE).
- Communicate quality concerns, process deviations, and safety issues to supervisors.
- Support equipment cleaning, calibration, validation, and continuous improvement activities as needed
- Assist with training new team members and provide backup support in other production areas.
Qualifications and Requirements
- High School Diploma or GED required.
- Basic understanding of manufacturing processes and production workflows.
- Ability to follow SOPs, work instructions, and product specifications.
- Attention to detail and ability to perform visual inspections.
- Ability to complete documentation accurately and legibly.
- Strong teamwork, communication, and organizational skills.
- Willingness to work in a cleanroom or controlled manufacturing environment.
- Ability to comply with gowning requirements and wear appropriate PPE.
- Spanish/English bilingual skills are preferred.
- Previous manufacturing, assembly, packaging, or medical device experience is an advantage.