Manufacturing Quality & Compliance Investigator

Avecia Pharma; Milford (MA); Hybrid; USD 78,000 - 94,000; Full time

Job summary

Avecia Pharma is seeking a Manufacturing Compliance Specialist to support quality and safety investigations, ensure corrective actions are effective, and help maintain compliant documentation across the manufacturing group.

The role partners with managers and staff to drive root cause analysis, revise SOPs and batch records, participate in audits, and promote a culture of quality and safety through strong technical writing and cross-functional collaboration.

Qualifications

• BS in chemistry, biology or engineering required.
• 3–5 years in a cGMP pharmaceutical manufacturing environment writing investigations and quality documents.
• Strong technical writing and communication skills.

Responsibilities

• Facilitate, document, and review investigations to identify root causes and ensure corrective actions.
• Support originating and revising SOPs and batch records.
• Audit quality and safety systems to ensure continual compliance.
• Assist with on-time performance using visual management tools.
• Provide training on quality and safety compliance for manufacturing staff.
• Provide technical writing support for quality investigations.

Skills

Technical writing

Root cause analysis

Lean/SS certification

Excel

Cross-functional teamwork

Communication skills

cGMP experience

Statistical software

Education

BS in Chemistry / Biology / Engineering

Tools

Microsoft Excel

MS Office

Statistical software

Job description

Avecia Pharma is seeking a Manufacturing Compliance Specialist to support quality and safety investigations, ensure corrective actions are effective, and help maintain compliant documentation across the manufacturing group.

The role partners with managers and staff to drive root cause analysis, revise SOPs and batch records, participate in audits, and promote a culture of quality and safety through strong technical writing and cross-functional collaboration.