Quality Assurance Specialist I — Batch Records & Compliance

Emergent BioSolutions; Canton (MA); On-site; USD 111,000 - 134,000; Full time

Job summary

Emergent BioSolutions is seeking a Specialist I, Quality Assurance in Canton, MA. The role manages Batch Record Review, Product/Raw Material disposition, and SAP Master Data while supporting APR and complaint programs.

You will provide on-the-floor QC support and lead quality projects to ensure compliance. Requires a Bachelor's in a scientific field and at least 5 years of cGMP QA experience, with strong SAP and regulatory knowledge (US/EU).

Qualifications

• Bachelor’s Degree in Scientific or related fields is required.
• At least five years of cGMP quality experience is required.
• Experience with product and raw material disposition is required.
• Strong SAP Master Data experience is required.
• Batch Record review experience is a must.
• Extensive GMP and regulatory knowledge (US/EU) is essential.
• Excellent communication skills, both written and oral, are essential.

Responsibilities

• Review/Approve Batch Records (APS, Engineering, Development runs) and related docs.
• Disposiiton of Product and Raw Materials and components; SAP MD SME.
• Provide on-the-floor quality oversight and real-time issue resolution with operations.
• Generate data for APR/complaints metrics to improve compliance.
• Create, review, and approve SOPs.
• Own quality records (Deviation/CAPA/Change Control).
• Lead/Support the Complaint program and APR processing.
• Work independently and strategically to support business goals.
• Lead or support continuous improvement projects with cross-functional teams.

Skills

Batch Record Review

SAP Master Data

Deviation/ CAPA/ Change Control

APR/PQR

US/EU Pharma Regulations

GMP Principles

On-the-Floor Manufacturing Support

Communication Skills

Education

Bachelor's Degree in Scientific or related fields

Tools

SAP

Job description

Emergent BioSolutions is seeking a Specialist I, Quality Assurance in Canton, MA. The role manages Batch Record Review, Product/Raw Material disposition, and SAP Master Data while supporting APR and complaint programs.

You will provide on-the-floor QC support and lead quality projects to ensure compliance. Requires a Bachelor's in a scientific field and at least 5 years of cGMP QA experience, with strong SAP and regulatory knowledge (US/EU).