Responsibilities:
- Execute manufacturing, assembly, labeling, packaging, and inspection activities per approved procedures and production schedules.
- Independently run manufacturing operations ensuring compliance with GMP/GDP and company standards.
- Complete batch records, logbooks, and production documentation accurately and contemporaneously.
- Set up, operate, troubleshoot, and perform basic maintenance on manufacturing equipment.
- Perform in-process inspections; conduct line clearances, room preparation, product changeovers, and equipment setup.
- Support material handling (staging, issuing, reconciliation of in-process materials and finished goods).
- Identify/escalate process deviations, equipment issues, quality concerns, and safety risks.
- Support deviation investigations, nonconformance, CAPAs, and root cause analyses.
- Participate in process validation, equipment qualification, and manufacturing engineering activities.
- Train/mentor junior personnel; support continuous improvement.
- Collaborate with QA/QC, Engineering, Supply Chain, and other teams; maintain inspection readiness.
- Comply with safety policies, GMP regulations, and training requirements.
Required/Preferred Qualifications & Skills:
- Working knowledge of cGMP, GDP, and quality system requirements.
- Proficient in manufacturing documentation and batch record execution.
- Ability to operate/troubleshoot manufacturing and packaging equipment.
- Strong attention to detail; organizational/problem-solving skills; verbal/written communication.
- Basic proficiency with electronic quality management systems (preferred).
- Train others; work independently with limited supervision.
- Lift up to 25 lbs; wear PPE incl. cleanroom gowning; stand/walk/bend/reach/repetitive motions for extended periods.
- Eye exam required.
Experience:
- 2β5 years in a regulated manufacturing environment.
- Medical device, pharmaceutical, biotech, or combination product manufacturing required.
- GMP equipment operation/documentation preferred.
Education:
- High School Diploma or GED required; associate degree/technical certification/coursework preferred.
Compensation:
- Salary range: $32.21β$41.76 USD.