Quality Assurance Specialist II, Manufacturing Quality Assurance

Nitto Avecia; Milford (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the biotechnology sector seeks a Quality Assurance Specialist II to oversee manufacturing quality assurance activities. This full-time role entails executing line clearances, facilitating compliance with GMP regulations, and leading continuous improvement initiatives. Ideal candidates will possess strong problem-solving skills and experience in a regulated industry.

Qualifications

• At least 3 years' experience in a regulated/GMP industry, preferably pharmaceuticals or biotechnology.
• Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
• Experience with clinical and commercial manufacturing preferred.

Responsibilities

• Oversee daily manufacturing batches and operational support activities.
• Execute line clearance and ensure compliance with Good Manufacturing Practices.
• Lead continuous improvement projects based on audit findings.

Skills

Problem-Solving

Adaptability

Communication

Team Collaboration

Tools

eQMS

Job description

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Quality Assurance Specialist II, Manufacturing Quality Assurance

May 29, 2025

Regular Full Time

About this opportunity :

The QA Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are on-going daily. This is a second shift position (Mon-Fri).

Key Responsibilities:

• Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists.
• Assist with production and QC to provide Good Manufacturing and Laboratory Practices.
• Understand and execute MQA responsibilities that are defined in SOP.
• Monitoring manufacturing operations including cleaning by conducting reviews of logbooks.
• Escalate detected major issues on the floor to MQA and QA management.
• Review facility cleaning, material transfers and personnel hygiene control
• Providing quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance).
• Based on outcomes of QMRs, quality council, internal and external audit findings, and QA operational (e.g., MQA) findings identify, propose and lead continuous improvement projects.
  Provide Quality oversight and compliance guidance on new building program initiatives.
  Train, motivate, monitor, and lead quality teams through necessary change.
  

Required Skills/Abilities:

• At least 3 years’ experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
• Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
• Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
• Problem-solving skills with the ability to adapt to changing priorities and timelines.
• Ability to build positive working partnerships with other department teams.
• Experienced in the use of electronic systems such as eQMS
• Prior experience with clinical and commercial manufacturing is preferred.
• Requires the ability to gown into clean rooms and wear PPE.