Senior Stability Technologist

Location: Warren

** 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 required (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,…