Operational Quality Specialist, External Manufacturing

JMD Technologies Inc.; Boston (MA); On-site; USD 90,000 - 120,000; Part time

Job summary

JMD Technologies Inc. is seeking an Operational Quality Specialist, External Manufacturing to provide QA support across manufacturing, analytical labs, and materials management for external programs.

You will review batch data, deviations, and QC releases to support product disposition. The role involves leading event investigations, Root Cause Analysis, and CAPA, with strong communication across internal and external partners.

Qualifications

• Bachelor’s degree in a scientific or allied health field, or equivalent combination of education and experience.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, Root Cause Analysis, and CAPA.
• Familiarity with Oracle, TrackWise, and Veeva.
• Proficient in Microsoft Office.

Responsibilities

• Review batch data and support product disposition.
• Assist with quality audits and external inspections.
• Monitor quality metrics and reporting.
• Lead investigations and CAPA with a risk‑based approach.
• Communicate proactively with internal and external partners.

Skills

Event investigations

Root Cause Analysis

CAPA

GxP knowledge

Communication skills

Education

Bachelor’s degree in a scientific or allied health field

Tools

Oracle

TrackWise

Veeva

Microsoft Office

Job description

Title : Operational Quality Specialist, External Manufacturing

Employment Type: Contract

Status: Accepting Candidates

About the Role

The Operational Area Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs.

This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation supporting product disposition.

Key Responsibilities

Batch Review & Product Release

• Review executed batch records and provide customer approval for quality tasks for externally Manufactured products
• Perform final review of executed batch and/or critical systems documentation
• Determine document acceptability using standard operating procedures
• Ensure all required documentation is present and acceptable prior to product and/or system release
• Support day-to-day management of the batch release process

Quality Systems & Compliance

• Assist with preparation for quality audits and participate in corporate audits and external inspections as needed
• Maintain files so documents are readily available and easily retrievable
• Assist with monthly/quarterly Quality System data review, metrics, and reporting
• Escalate critical and major findings to Quality management
• Monitor key performance indicators in collaboration with Quality Systems and other GxP Operational areas

Investigations & CAPA

• Provide QA support and oversight of GMP manufacturing operations
• Lead event investigations, Root Cause Analysis, and CAPA
• Evaluate quality matters and make decisions utilizing a risk-based approach
• Communicate proactively with internal and external partners and management
• Apply strong communication and influencing skills
• Support Cell and/or Gene Therapy QA activities
• Support aseptic processing and quality metrics, dashboards, analysis, and improvement programs

Qualifications

• Bachelor’s degree in a scientific or allied health field, or equivalent combination of education and experience
• Experience providing QA support and oversight of GMP manufacturing operations
• Experience successfully leading event investigations, Root Cause Analysis, and CAPA
• Experience with network-based applications such as:
• Oracle
• TrackWise
• Veeva
• Proficiency in Microsoft Office applications
• Strong critical thinking and problem-solving skills
• Ability to evaluate quality matters and make risk-based decisions

Preferred Qualifications

• Cell and/or Gene Therapy QA experience
• Working knowledge of aseptic processing
• Experience with quality metrics, dashboards, analysis, and improvement programs
• Experience participating in event investigations, Root Cause Analysis, and CAPA
• Knowledge of current industry trends and ability to use the latest technologies