Manufacturing Associate II

Responsibilities:

• Perform manufacturing, assembly, labeling, packaging, and inspection activities per approved procedures and production schedules.
• Independently execute manufacturing operations in compliance with GMP, GDP, and company standards.
• Complete batch records, logbooks, and other production documentation accurately and contemporaneously.
• Set up, operate, troubleshoot, and perform basic maintenance on manufacturing equipment.
• Conduct in-process inspections and verify product quality.
• Perform line clearances, room preparation, product changeovers, and equipment setup.
• Assist with material handling (staging, issuing, reconciliation of in-process materials and finished goods).
• Identify and elevate process deviations, equipment issues, quality concerns, and safety risks.
• Support deviation investigations, nonconformance activities, CAPAs, and root cause analyses.
• Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
• Train/mentor junior personnel.
• Support continuous improvement for quality, efficiency, productivity, and compliance.
• Collaborate with QA, QC, Engineering, Supply Chain, and other teams.
• Maintain production areas and equipment in inspection-ready condition.
• Comply with company safety policies, GMP regulations, and training requirements.

• Working knowledge of cGMP, GDP, and quality system requirements.
• Proficiency in manufacturing documentation and batch record execution.
• Ability to operate/troubleshoot manufacturing and packaging equipment.
• Attention to detail; commitment to product quality.
• Organizational and problem-solving skills; strong verbal/written communication.
• Basic proficiency with electronic quality management systems (preferred).
• Ability to train others; work independently with limited supervision.
• Lift up to 25 lbs; wear required PPE including cleanroom gowning.
• Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods; requires an eye exam.
• Experience:
  
  2–5 years in a regulated manufacturing environment; medical device/pharma/biotech/combination product manufacturing (required). GMP equipment operation/documentation (preferred).
• Education:
  
  High School Diploma or GED required; associate degree/technical certification/coursework in related fields (preferred).