Lead Quality Control Technologist – OOS & Root-Cause Expert

Werfenlife SA.; New Jersey; On-site; USD 95,000 - 130,000; Full time

Job summary

Werfen is seeking a lead Quality Control professional to guide daily QC activities in our laboratory, overseeing routine testing, scheduling, and data reporting while assisting the lab manager.

The role requires 5+ years in a medical device or pharmaceutical GMP QC environment, experience with OOS investigations, and knowledge of 21 CFR Part 210/211 or 820; ISO 13485 preferred. Strong leadership and training skills are essential, with audits experience advantageous.

Qualifications

• Bachelor’s degree in biology or chemistry or related field; 5+ years in medical device or pharmaceutical GMP QC lab.
• Experience performing OOS investigations (RCI) and root cause analyses.
• Experience with test method validation, data trending, and SOP/WIN documentation.
• Familiarity with 21 CFR Part 210/211 and/or 820 regulations; ISO 13485 desired.

Responsibilities

• Lead QC staff and provide guidance on daily tasks; schedule QC activities.
• Perform and schedule testing of materials, in-process, and final products per SOPs within defined timeframes.
• Train new employees and current staff on new test methods; maintain training records.
• Report and investigate out-of-specification results and deviations; lead root cause analyses.
• Write/revise SOPs, WI, and QC documentation; maintain cGMP-compliant records.

Skills

Pipetting

GMP Lab

OOS Investigations

Root Cause Analysis

Data Trending

Leadership

Training

Audits

Education

Bachelor’s degree in biology or chemistry or related field

Tools

Win/SOP system

Job description

Werfen is seeking a lead Quality Control professional to guide daily QC activities in our laboratory, overseeing routine testing, scheduling, and data reporting while assisting the lab manager.

The role requires 5+ years in a medical device or pharmaceutical GMP QC environment, experience with OOS investigations, and knowledge of 21 CFR Part 210/211 or 820; ISO 13485 preferred. Strong leadership and training skills are essential, with audits experience advantageous.