QMS Quality Specialist II

Enzene INC•Pennington, NJ

17h•$70,000 - $86,000•Onsite

About The Position

The U5 QMS Quality Specialist II is responsible for overseeing and managing three key critical quality system processes at the site level: Deviations/OOS, Notification to Management (NTM), and Client Complaints. This role ensures compliance with global procedures, regulatory expectations, and client requirements while driving continuous improvement, maintaining system oversight, and serving as the site Subject Matter Expert (SME) for all three Quality System areas. This role plays a critical part in maintaining robust and inspection‑ready QMS, supporting operational excellence, and driving continuous improvement initiatives at the site

Requirements

Bachelor’s degree in a scientific or engineering discipline, or equivalent experience.
six (6)+ years GMP industry and two (2)+ years Quality experience. Non-Conformance Management experience is preferred.
Strong understanding of GMP principles and expectations, with the ability to apply them effectively in daily operations.
Comprehensive knowledge of regulatory requirements relevant to pharmaceutical/biotech manufacturing and quality compliance.
Proficient in Quality Systems processes, including their purpose, interdependencies, and execution in a regulated environment.
Demonstrated ability to lead, influence, and communicate across multi site, multi cultural teams.
Capable of clearly explaining, coaching, and supporting cross functional teams through Non-Conformance Management processes and best practices.
Able to articulate and defend Deviation/OOS, Client Complaints and NTM rationale, and compliance expectations during internal and external audits.

Responsibilities

Serve as the Business Process Owner and SME for Deviation/OOS, NTM, and Client Complaints.
Collaborate with Global QMS teams to ensure alignment with global procedures and standards.
Implement global and/or local processes and procedural updates to meet industry expectations.
Develop, implement, and deliver training for Deviation/OOS, NTM, and Client Complaint processes.
Support role-based training across departments and provide onboard training for new staff.
Develop and implement KPIs for all three BPO processes.
Track and report performance metrics for Management Review Meetings.
Identify trends, risks, and improvement opportunities through data analysis.
Serve as SME during internal audits, client audits, and regulatory inspections.
Provide required documentation, responses, and system walkthroughs.
Support audit responses related to assigned processes
Oversee the full lifecycle of Deviation and OOS records, including initiation, assessment, investigation, and closure.
Lead classification and initial impact assessment (Triage).
Execute client notification requirements per Quality Technical Agreements (QTAs).
Review Deviation/OOS records prior to client submission and obtain client approval before closure.
Perform final QA approval in AQEM and manage record extensions as needed.
Maintain the U5 Deviation/OOS master log and pull system reports as required.
Oversee the NTM process, ensuring timely reporting, escalation, and closure.
Coordinate NTM meetings, manage agendas, and document meeting minutes.
Provide site-level support for NTM‑related inquiries.
Maintain NTM records and logs in AQEM and generate reports as needed.
Oversee the end‑to‑end Client Complaint process, including initiation, investigation support, communication, and closure.
Communicate with clients regarding complaint status, inquiries, and closure requirements.
Maintain the U5 Client Complaint log and ensure documentation accuracy and compliance.