Responsibilities:
- Perform manufacturing, assembly, labeling, packaging, and inspection operations in a GMP environment.
- Follow approved SOPs, batch records, work instructions, and production schedules.
- Complete GMP documentation accurately and contemporaneously (GDP).
- Assist with material handling: staging, issuing, and reconciliation of in-process materials and finished goods.
- Conduct in-process inspections and quality checks.
- Maintain cleanroom/production areas per GMP and company policies.
- Perform line clearances, room setup, and product/room changeovers as required.
- Identify and report quality, safety, equipment, or process issues.
- Support investigations, deviations, corrective actions, and continuous improvement.
- Participate in equipment cleaning and routine maintenance.
- Comply with safety policies, GMP regulations, and training requirements.
- Collaborate with Quality, Engineering, Supply Chain, and other departments.
Required Skills/Knowledge:
- Basic understanding of GMP and quality system requirements; follow detailed written procedures.
- Strong attention to detail; accurate documentation.
- Organizational/time management skills; basic computer proficiency (Microsoft Office).
- Ability to work independently and in a team; effective verbal/written communication.
- Willingness to learn new processes/technologies.
- Lift up to 25 lbs; wear PPE (including cleanroom gowning).
- Ability to stand/walk/bend/reach and perform repetitive motions for extended periods.
- Position requires an eye exam.
Experience:
- 0β2 years manufacturing preferred.
- Medical device/pharma/biotech/combination product manufacturing preferred/plus.
- Regulated environment experience preferred.
Education:
- High School Diploma or GED required.
- Associate degree/technical certification/coursework in related field preferred.
Salary Range: $54,000 USD - $76,000 USD