Manufacturing Quality & Safety Compliance Specialist

Nitto Avecia; Milford (MA); On-site; USD 78,000 - 94,000; Full time

Job summary

Nitto Avecia is seeking a Manufacturing Compliance Specialist to support quality and safety investigations, corrective actions, and the creation and revision of quality documentation within the Manufacturing group. The role collaborates with managers, supervisors, and leads to foster a culture of compliance and continuous improvement.

The ideal candidate has a technical BS with 3-5 years in a cGMP pharmaceutical setting, strong technical writing, and experience conducting root cause analyses.

Qualifications

• A BS in a technical discipline is required; Chemistry, Biology, or Engineering preferred.
• 3-5 years of experience in a cGMP pharmaceutical manufacturing environment with experience writing investigations and quality documents.
• Experience leading departmental and cross-functional teams through peer-to-peer influence is recommended.
• Lean/SS certification is preferred.
• Strong technical writing and communication skills are required.
• Experience leading root cause analysis is recommended.
• Proficiency with Microsoft applications and Excel graphing tools; knowledge of statistical software is preferred.

Responsibilities

• Facilitate, document, and review compliance investigations to identify root causes and ensure corrective actions are effective and compliant.
• Originating and revising manufacturing SOPs and batch records.
• Audit quality and safety compliance systems including risk assessment, 5S, training, documentation, and manufacturing operations for continual compliance.
• Support on-time performance within the department using visual management tools.
• Provide training opportunities for manufacturing staff in quality and safety compliance.
• Provide technical writing support for quality investigations and ensure reporting standards are met.

Skills

Technical writing

Root cause analysis

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in Chemistry, Biology, or Engineering

Tools

Excel

Microsoft Office

Statistical software

Job description

Nitto Avecia is seeking a Manufacturing Compliance Specialist to support quality and safety investigations, corrective actions, and the creation and revision of quality documentation within the Manufacturing group. The role collaborates with managers, supervisors, and leads to foster a culture of compliance and continuous improvement.

The ideal candidate has a technical BS with 3-5 years in a cGMP pharmaceutical setting, strong technical writing, and experience conducting root cause analyses.