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Operational Quality Specialist, External Manufacturing at JMD Technologies Inc. Operational Quality Specialist, External Manufacturing at JMD Technologies Inc. in Brookline Village, Massachusetts Posted in 1 day ago.

Type:

full-time

Title :

Operational Quality Specialist, External Manufacturing Location:

Boston, MA - Seaport (On-site)

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 Collaboration & Communication 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 Strong communication and influencing skills Compensation $55-$65/hr Boston, MA - Seaport 100% On-site Monday-Friday, 8:00 AM-5:00 PM 6+ Month Contract