Sr. Specialist, Quality Systems

GenScript/ProBio•Pennington, NJ

20h•$70,000 - $90,000•Remote

About The Position

Contributes to the administration, maintenance, and continuous improvement of ProBio’s Quality Management System (QMS) to ensure compliance with applicable GMP regulations, industry standards, and company procedures for both clinical and commercial Cell and Gene Therapy products. This role supports quality system processes including deviations, lab investigations, Corrective and Preventative Actions (CAPA), change controls, complaints, risk management, training, document control, management review, and regulatory inspection readiness. The position collaborates cross-functionally with internal teams, customers, and external resources (when required) to ensure compliance and drive a culture of quality and operational excellence.

Requirements

Bachelor’s degree in a scientific discipline with 3+ years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment.
Demonstrated experience with GxP document management systems and/or other QMS (e.g. Veeva QualityDocs, Veeva QMS, TrackWise QMS etc.).
Demonstrated knowledge and understanding of business practices and procedures associated with GxP Document Control, Change Control, CAPA, Deviation and/or Lab investigations.
In-depth knowledge of quality risk management, Root Cause Analysis, and appropriate investigation tools.
Demonstrated understanding biologics manufacturing and laboratory activities.
Detailed knowledge and understanding of GMP regulations and compliance regulatory requirements.
Demonstrated ability to communicate proactively with a positive customer service attitude.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work virtually, independently, and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Responsibilities

Maintain and continuously improve ProBio Inc. and external Quality Management Systems ensuring GxP compliance with worldwide manufacturing regulations, guidelines, and current regulatory requirements for both clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.
Manage and perform Quality Assurance (QA) review and approval of documentation related to Change Control, Corrective and Preventative Action (CAPA), Deviations, Laboratory Investigations, incidents, complaints, exceptions, and Out of Specification (OOS) reports as generated by ProBio Hopewell, NJ facility in accordance with current QA procedures.
Facilitate and support ProBio internal team members with Root Cause Analysis and Investigations using established methodologies. Drives completion of Investigations and ensures timely implementation and effectiveness verification of CAPAs as needed.
Monitor quality system performance and overdue actions.
Support development, implementation, and monitoring of quality metrics and Key Performance Indicators (KPIs).
Analyze quality trends and generate quality management review reports. Recommend and implement process improvements to enhance effectiveness and compliance.
Participate in customer audits, regulatory inspections, and internal audits.
Coordinate responses to audit observations and inspection findings.
Maintain inspection readiness at all times.
Performs other tasks and assignments as needed and specified by management.

Benefits

medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
paid parental leave after just three (3) months of employment
paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
flexible spending and health savings accounts
life and AD&D insurance
short- and long-term disability coverage
legal assistance
supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
commuter benefits
well-being initiatives
peer-to-peer recognition programs