Senior Manufacturing Quality Investigations Specialist

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

The Senior Specialist in the Manufacturing Technical Operations (MTO) team at the Boston site leads high-complexity investigations, deviations, CAPAs, and Change Controls within the eQMS. This role is investigation-heavy, coordinating with cross-functional SMEs to drive timely closures in a regulated environment.

You will mentor junior investigators, apply RCA methodologies, and partner with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to strengthen process robustness and reduce

Qualifications

• Bachelor's degree required in Engineering, Life Sciences, Biotechnology, Project Management, or related field.
• 5-10 years of experience in pharmaceutical/biotech or regulated manufacturing environments.
• Strong understanding of cGMP, FDA/EMA regulations, and quality systems.
• Experience with electronic Quality Management Systems (eQMS) required.

Responsibilities

• Lead full-complexity deviation investigations, including triage, data collection, GEMBA walks, and SME coordination.
• Perform advanced root cause analysis using structured methodologies (5-Why, Fishbone, GEMBA, KT).
• Own CAPA records from initiation through closure, ensuring robust effectiveness checks and alignment with compliance expectations.
• Initiate, assess, and execute Change Control records with impact evaluations and cross-functional alignment.
• Conduct and support Analytical and QC investigations, including data trending and method performance review.
• Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
• Partner with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to drive investigation closure and continuous improvement.
• Provide SME during internal audits, external inspections, and regulatory interactions.
• Identify recurring issues and lead cross-functional initiatives to strengthen process robustness.
• Serve as a mentor and technical resource for junior investigators and MTO staff.

Skills

Investigation leadership

Root cause analysis

CAPA execution

Change control

Analytical investigations

Cross-functional collaboration

Regulatory knowledge

eQMS experience

Data trending

Technical writing

Education

Bachelor's degree in Engineering/Life Sciences/Biotechnology/PM

Tools

MES

LIMS

TrackWise

Job description

The Senior Specialist in the Manufacturing Technical Operations (MTO) team at the Boston site leads high-complexity investigations, deviations, CAPAs, and Change Controls within the eQMS. This role is investigation-heavy, coordinating with cross-functional SMEs to drive timely closures in a regulated environment.

You will mentor junior investigators, apply RCA methodologies, and partner with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to strengthen process robustness and reduce