Cell Therapy Quality Investigations Specialist

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Overtime availability

Administrative shift

1-year contract with extension

Job summary

Biopharma-Consulting-Jad-Group is seeking a Manufacturing Technical Operations (MTO) Quality Investigations Specialist for the Boston site. You will lead end‑to‑end quality investigations, including deviations, CAPAs, Change Controls, and analytical/QC investigations within the eQMS.

You will coordinate with SMEs across functions, perform robust root cause analysis, and ensure timely, compliant documentation aligned with cGMP and QA standards.

Qualifications

• 2–5 years of experience in pharmaceutical/biotech or regulated manufacturing.
• Demonstrated experience conducting quality investigations, deviation management, and CAPA execution.
• Working knowledge of cGMP and FDA/EMA regulations.
• Experience with electronic Quality Management Systems (eQMS) preferred.
• Strong analytical, problem‑solving, and technical writing skills.
• Ability to work on‑site in a dynamic manufacturing environment and collaborate across functions.
• Comfortable handling moderate‑complexity investigations with limited oversight.

Responsibilities

• Lead and execute deviation investigations, including triage and cross‑functional SME coordination.
• Perform root cause analysis using structured tools (5‑Why, Fishbone, GEMBA).
• Own and manage CAPA records from initiation through closure.
• Initiate, draft, and execute Change Control records with impact assessments and implementation plans.
• Conduct and support Analytical and QC investigations, including trend reviews.
• Ensure quality records meet internal and regulatory expectations for completeness, accuracy, and timeliness.
• Partner with Manufacturing, QC, QA, MS&T, and Engineering to drive investigation closure.
• Maintain rigorous documentation discipline within the eQMS per cGMP and SOPs.
• Support audit readiness and provide investigation documentation during inspections.
• Contribute to continuous improvement initiatives to reduce deviations and strengthen manufacturing robustness.
• 1-year contract with possible extension

Skills

Investigations

Root cause analysis

CAPA execution

Change Control

Analytical thinking

Technical writing

Documentation discipline

Cross‑functional collaboration

On-site manufacturing

Education

Bachelor's degree in Engineering/Biotechnology/Life Sciences

Tools

MES

LIMS

TrackWise

eQMS

Job description

Biopharma-Consulting-Jad-Group is seeking a Manufacturing Technical Operations (MTO) Quality Investigations Specialist for the Boston site. You will lead end‑to‑end quality investigations, including deviations, CAPAs, Change Controls, and analytical/QC investigations within the eQMS.

You will coordinate with SMEs across functions, perform robust root cause analysis, and ensure timely, compliant documentation aligned with cGMP and QA standards.