The Manufacturing Technical Operations (MTO) Quality Investigations Specialist is responsible for the end‑to‑end execution of quality records supporting cell therapy manufacturing at the Boston site. This role focuses heavily on investigations, including Deviations, CAPAs, Change Controls, and Analytical/Quality Control investigations within the electronic Quality Management System (eQMS). The Specialist ensures timely triage, coordination with Subject Matter Experts (SMEs), robust root cause analysis, and compliant documentation aligned with MTO and QA standards.
Key Responsibilities
- Lead and execute deviation investigations, including triage, data gathering, GEMBA walks, and coordination with cross‑functional SMEs.
- Perform thorough root cause analysis using structured problem‑solving tools (e.g., 5‑Why, Fishbone, GEMBA).
- Own and manage CAPA records from initiation through closure, ensuring effectiveness checks and alignment with compliance best practices.
- Initiate, draft, and execute Change Control records, collaborating with technical, manufacturing, and quality teams to ensure accurate impact assessments and implementation plans.
- Conduct and support Analytical and Quality Control investigations, including trending, data review, and identification of systemic issues.
- Ensure all quality records meet internal and regulatory expectations for completeness, accuracy, and timeliness.
- Partner closely with Manufacturing, QC, QA, MS&T, and Engineering to drive investigation closure and continuous improvement.
- Maintain strong documentation discipline within the eQMS, ensuring adherence to cGMP, internal SOPs, and industry standards.
- Support audit readiness and provide investigation‑related documentation during internal and external inspections.
- Contribute to continuous improvement initiatives aimed at reducing recurring deviations and strengthening manufacturing robustness.
Requirements
- Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field.
- 2–5 years of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
- Demonstrated 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.
- Strong analytical, problem‑solving, and technical writing skills.
- Ability to work on‑site in a dynamic manufacturing environment and collaborate across multiple functions.
- Comfortable handling moderate‑complexity investigations with limited to moderate oversight.
Preferred Skills
- Experience in cell therapy, biologics, or aseptic manufacturing.
- Familiarity with MES, LIMS, TrackWise, or similar systems.
- Training in structured RCA methodologies (e.g., Kepner‑Tregoe, 5‑Why, Ishikawa).
- Ability to manage multiple records simultaneously while meeting deadlines.
Benefits
- 1- year contract with possible extension
- Administrative shift
- Overtime availability