Lead QC Technologist - OOS Investigations & Training

Werfen; Warren Township (NJ); On-site; USD 95,000 - 125,000; Full time

Job summary

Werfen in New Jersey seeks a Quality Control lead to manage routine lab QC activities, schedule testing, and report daily status. You will train new staff, investigate OOS, and drive root cause analyses while upholding cGMP and regulatory requirements.

The role requires a biology/chemistry background, 5+ years in medical device/pharma QC, and experience with SOPs, WIN systems, and audits. No travel is required for this senior position.

Qualifications

• Bachelor's degree in biology or chemistry and 5+ years in a medical device/pharma QC lab.
• Experience with 21 CFR 210/211 and/or 820; ISO 13485 knowledge preferred.
• Proven ability to investigate OOS and conduct root cause analyses.

Responsibilities

• Provide direction to QC staff and schedule daily/weekly QC activities.
• Perform/testing planning for materials, in-process, and final release per SOPs.
• Train new employees and oversee OOS investigations and root cause analyses.
• Write/revise SOPs and QC documents; ensure cGMP compliance and records.
• Lead audits and participate in internal/external regulatory reviews.

Skills

Pipetting accuracy

Leadership

Problem solving

GMP knowledge

Software literacy

Education

Bachelor's degree in biology or chemistry

Tools

Laboratory software

SOP/WIN documentation

Job description

Werfen in New Jersey seeks a Quality Control lead to manage routine lab QC activities, schedule testing, and report daily status. You will train new staff, investigate OOS, and drive root cause analyses while upholding cGMP and regulatory requirements.

The role requires a biology/chemistry background, 5+ years in medical device/pharma QC, and experience with SOPs, WIN systems, and audits. No travel is required for this senior position.