Technologist III – Stability

Location: Warren, NJ (On-site)
Schedule: Monday–Friday | First Shift (Flexible start between 7:00 AM–10:00 AM)
Compensation: $36–$44/hour ( ~ $74,000-$91,000/year)

Position Overview

An established, GMP-regulated manufacturer in the transfusion and transplant space is seeking a Quality Control Technologist III – Stability to serve as the subject matter expert (SME) for product stability within the Quality Control laboratory.

This role will lead the development and implementation of an in-house stability program while supporting core QC functions including incoming, in-process, final release, and special testing activities. The position is highly hands-on and suited for a detail-oriented QC professional with strong stability program experience in a pharmaceutical or medical device GMP environment.

This is a replacement role on a collaborative QC team of four technologists and offers strong visibility, ownership, and potential growth into future leadership opportunities.

Key Responsibilities

Stability Program Leadership (Primary Focus)

• Serve as QC subject matter expert for product stability
  

• Develop, write, and execute stability protocols and reports
  

• Monitor stability time points and ensure proper sample pulls and testing intervals
  

• Perform stability testing and data analysis
  

• Conduct trending analysis across stability timelines
  

• Develop annual stability schedules and determine product requirements
  

• Implement and track new in-house stability processes
  

• Maintain detailed documentation in compliance with cGMP requirements

Quality Control Testing & Operations

• Perform and schedule:

  • Incoming raw material testing

    
    

  • In-process testing

    
    

  • Final release testing

    
    

  • Stability testing

    
    

  • Method validations and equipment validations

    
    

  • Threshold and special testing

    
    

  
  

• Ensure compliance with 21 CFR Part 210/211 and/or 820 regulations

  
  

• Maintain accurate, legible, and complete records in accordance with cGMP

  
  

• Report and escalate out-of-specification (OOS) results and deviations

  
  

• Lead and assist in Phase I OOS investigations and root cause analyses

  
  

• Draft and revise SOPs, work instructions, and QC specifications

  
  

• Support equipment calibration and maintenance activities

Team & Laboratory Support

• Act as team lead in daily QC operations (no direct reports, but new hire training)
  

• Assist supervisor and leadership with scheduling and workflow planning
  

• Create daily and weekly QC schedules
  

• Train new and existing QC staff 
  

• Guide training documentation and ensure compliance
  

• Support a collaborative, fast-paced team environment

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, or related scientific field
  

• 3–5+ years of QC laboratory experience in a pharmaceutical or medical device GMP environmen
  

• Minimum 2 years of hands-on stability testing experience is required (non-negotiable)
  

  • 4+ years of stability experience preferred (testing, protocol writing, data trending, report writing)
    

  
  

• Experience working under 21 CFR Part 210/211 and/or 820 regulations
  

• Strong experience with OOS investigations aligned with FDA guidelines
  

• Excellent documentation practices under cGMP

Technical Skills

• Molecular biology techniques preferred (PCR experience strongly desired)
  

• Strong pipetting skills (including multi-channel pipettes)
  

• Experience with stability data trending and analysis
  

• Experience writing stability protocols and reports
  

• Method validation and equipment qualification experience preferred
  

• Knowledge of ISO 13485 a plus

Soft Skills & Work Style

• Detail-oriented with strong organizational skills
  

• Comfortable managing multiple stability time points and deadlines
  

• Able to track and implement new processes step-by-step
  

• Confident speaking up when clarification is needed
  

• Willing to train and mentor others
  

• Able to thrive in a fast-paced, collaborative laboratory
  

• Team-oriented and able to work effectively across varying experience levels

Work Environment

• Fully onsite position in Warren, NJ
  

• Monday–Friday, first shift
  

• Flexible start time between 7:00 AM – 10:00 AM
  

• Team of five QC technologists
  

• Diverse, collaborative team culture

Growth Opportunity

This role offers visibility and ownership within QC operations and may provide a future path toward supervisory responsibilities for high-performing individuals.

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