Cell Therapy Quality Investigations Specialist 1-Year

BioPharma Consulting JAD Group; Boston; On-site; PHP 5,016,000 - 6,583,000; Full time

Benefits offered by this job

1-year contract

Administrative shift

Overtime

Job summary

BioPharma Consulting JAD Group is seeking a Manufacturing Technical Operations (MTO) Quality Investigations Specialist for our Boston site. The role centers on end-to-end quality record execution, with emphasis on investigations, deviations, CAPAs, change controls, and analytical/quality control investigations within the eQMS.

The candidate will lead triage, root cause analysis, and documentation to ensure compliance with cGMP, FDA/EMA expectations, and internal SOPs, while collaborating across

Qualifications

• Bachelors degree in Engineering, Biotechnology, Life Sciences, or related field.
• Experience conducting quality investigations, deviation management, and CAPA execution.
• Working knowledge of cGMP, FDA/EMA regulations, and quality systems.
• Experience with electronic Quality Management Systems (eQMS) preferred.

Responsibilities

• Lead and execute deviation investigations, including triage and data gathering.
• Perform root cause analysis using structured problem‑solving tools.
• Own and manage CAPA records from initiation through closure.
• Initiate, draft, and execute Change Control records with cross‑functional teams.
• Conduct Analytical and Quality Control investigations, including data review and trending.
• Ensure quality records meet internal and regulatory expectations for completeness and timeliness.
• Collaborate with Manufacturing, QC, QA, MS&T, and Engineering to close investigations.
• Maintain documentation discipline within the eQMS and ensure compliance with cGMP and SOPs.
• Support audit readiness and provide investigation documentation during inspections.
• Contribute to continuous improvement initiatives to reduce deviations.

Skills

Investigations

Root cause analysis

CAPA execution

Change Control

eQMS

Data analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Biotechnology/Life Sciences

Tools

eQMS

TrackWise

LIMS

MES

Job description

BioPharma Consulting JAD Group is seeking a Manufacturing Technical Operations (MTO) Quality Investigations Specialist for our Boston site. The role centers on end-to-end quality record execution, with emphasis on investigations, deviations, CAPAs, change controls, and analytical/quality control investigations within the eQMS.

The candidate will lead triage, root cause analysis, and documentation to ensure compliance with cGMP, FDA/EMA expectations, and internal SOPs, while collaborating across