Quality Control Technologist III

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

Overview

Job Summary

This job is a lead role in the quality control laboratory, performing routine activities and assisting the manager in daily operations. The successful candidate executes all test methods performed in the lab, schedules testing activities, reports status in daily update meetings, trains new employees, performs OOS and root cause investigations, reviews data and records, leads projects, and updates WIN/SOPs.

Responsibilities

• Provides direction and guidance to Quality Control staff in the performance of daily tasks. Creates daily and weekly scheduling of all QC related activities.
• Performs and schedules testing for incoming raw material, in‑process, final release and inspection of BioArray products according to approved SOPs and other applicable documents within defined timeframes. Performs and schedules stability, method validations, equipment validations, threshold analysis processes and other special testing.
• Acts as OJT trainer to train new employees and current employees on new test methods. Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions.
• Reports and escalates out‑of‑specification results and deviations to the department supervisor/manager. Assists and leads the investigations, root cause analyses, and reports for out‑of‑specification results and deviations.
• Writes/revises SOPs, WI, QC specification/testing documents. Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP).
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner. Performs, schedules and delegates equipment calibration and maintenance.
• Performs data review of QC test data. Works with quality assurance (QA) to ensure batch records are approved in a timely manner.
• Stays up‑to‑date on medical device regulations. Participates in internal and external audits.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking / Key Relationships

This role interacts with the following areas within the company (at a minimum):

• Quality Assurance and Quality Control
• Operations
• Regulatory Affairs
• Technical Support and R&D

This role may interact with the following external partners:

• External auditors
• Regulatory agencies

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in biology or chemistry or a related field. Five (5) or more years experience in a medical device or pharmaceutical GMP quality control laboratory. Experience working under 21 CFR Part 210/211 and/or 820 regulations required. Knowledge of ISO 13485 desired.
• Two (2) or more years of experience performing out of specification (OOS) and/or root cause investigations (RCI) required. Experience with test method validation, performing data trending, and writing/revising SOP/WIN preferred.
• Experience performing OOS Phase I investigations, in alignment with FDA guidelines, required.
• Experience in internal/external audits is a plus.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Ability to accurately pipette solutions from 0.01 µl up to 10 ml.
• Critical thinking and problem‑solving abilities.
• Ability to learn and work with software programs (off‑the‑shelf and company‑designed).
• Ability to work in a GMP lab environment, including donning the appropriate PPE (personnel protective equipment).
• Overtime work may be required (occasionally).
• Ability to lead others to complete tasks and projects.

No travel is required for this position.

Legal and Equal Opportunity Statement

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

Company Overview

Werfen is a worldwide leader in specialized diagnostics, operating in more than 30 countries with a workforce of over 7,000 employees.