QA Compliance Specialist — Quality Systems & Risk

Emergent Biosolutions; Canton (MA); On-site; USD 129,000 - 156,000; Full time

Benefits offered by this job

Merit increases

Stock options

Comprehensive benefits

Job summary

Emergent BioSolutions is seeking a Specialist I in QA Compliance to provide independent QA oversight of Quality Systems supporting commercial manufacturing at the site. The role applies regulatory knowledge to risk management, troubleshoot complex issues and ensure plant compliance.

You will lead audits, review diverse quality documentation, support supplier quality programs, and interact with senior leadership to drive sound quality decisions.

Qualifications

• Bachelor's degree in scientific or related field required.
• Six+ years of cGMP quality experience preferred.
• Experience with US, EU and Canadian pharmaceutical regulations and ISO standards.
• Excellent communication, facilitation and presentation skills.

Responsibilities

• Represent the department in interactions with internal units, contract partners, and regulatory officials.
• Review regulatory submissions, SOPs, deviation investigations, CAPAs, and change controls for compliance and accuracy.
• Support supplier quality program including conducting supplier audits.
• Lead cross-functional teams to address facility issues and root-cause analysis.
• Plan and conduct internal and external (supplier) quality system audits and review prior audits.

Skills

QA oversight

Regulatory knowledge

Change control

GMP compliance

Auditing

Root cause analysis

Education

Bachelor's Degree in Scientific or related fields

Tools

PowerPoint

Excel

Word

Outlook

Visio

Access

Job description

Emergent BioSolutions is seeking a Specialist I in QA Compliance to provide independent QA oversight of Quality Systems supporting commercial manufacturing at the site. The role applies regulatory knowledge to risk management, troubleshoot complex issues and ensure plant compliance.

You will lead audits, review diverse quality documentation, support supplier quality programs, and interact with senior leadership to drive sound quality decisions.