Specialist I, QA Compliance
Emergent BioSolutions
August 20, 2026
On-site
Canton, MA
Operations
Job Summary:
Specialist I, QA Compliance provides independent QA oversight of quality systems supporting commercial product manufacturing at the site, and manages activities for one or more quality systems or cross-functional projects. Uses technical and regulatory expertise to analyze risk, troubleshoot complex issues, and support quality systems, plant compliance, change control, and risk management.
Essential Functions:
- Represent the department with internal teams, contract partners, and regulatory officials.
- Critically review documentation for completeness, accuracy, and compliance (e.g., regulatory submissions, complaints, annual product reviews, quality agreements, supplier notifications, SOPs, master plans, deviations, CAPAs, change controls).
- Support Supplier Quality Program (e.g., supplier audits as assigned).
- Develop/revise quality technical agreements; assess supplier change impact; investigate supplier nonconformities for GMP operations.
- Lead/participate in cross-functional problem solving (root cause, CAPAs, product impact assessment).
- Plan and conduct internal and external (supplier) quality audits.
- Drive inspection readiness; serve as subject matter expert in quality systems.
- Track and analyze negative trends; propose/implement corrective actions; present to management.
Qualifications & Skills:
- Bachelor’s in scientific/related field.
- 6+ years cGMP Quality experience.
- Strong commercial manufacturing experience (large molecules).
- Preferred: Quality Auditor and/or Six Sigma.
- Experience with US/EU/Canadian pharma regulations and ISO standards; expert GMP knowledge.
- Strong communication, facilitation, analytical, and interpersonal skills.
- Proficient with PC tools (PowerPoint, Excel, Word, Outlook, etc.).
Compensation/Benefits:
- Estimated base salary: $129,000–$156,000.
- Comprehensive benefits package (eligibility per plan documents).
Application Instructions:
- If selected for an interview, speak with an HR partner about compensation philosophy and available benefits.
Specialist I, QA Compliance provides independent QA oversight of quality systems supporting commercial product manufacturing at the site, and manages activities for one or more quality systems or cross-functional projects. Uses technical and regulatory expertise to analyze risk, troubleshoot complex issues, and support quality systems, plant compliance, change control, and risk management.
Essential Functions:
- Represent the department with internal teams, contract partners, and regulatory officials.
- Critically review documentation for completeness, accuracy, and compliance (e.g., regulatory submissions, complaints, annual product reviews, quality agreements, supplier notifications, SOPs, master plans, deviations, CAPAs, change controls).
- Support Supplier Quality Program (e.g., supplier audits as assigned).
- Develop/revise quality technical agreements; assess supplier change impact; investigate supplier nonconformities for GMP operations.
- Lead/participate in cross-functional problem solving (root cause, CAPAs, product impact assessment).
- Plan and conduct internal and external (supplier) quality audits.
- Drive inspection readiness; serve as subject matter expert in quality systems.
- Track and analyze negative trends; propose/implement corrective actions; present to management.
Qualifications & Skills:
- Bachelor’s in scientific/related field.
- 6+ years cGMP Quality experience.
- Strong commercial manufacturing experience (large molecules).
- Preferred: Quality Auditor and/or Six Sigma.
- Experience with US/EU/Canadian pharma regulations and ISO standards; expert GMP knowledge.
- Strong communication, facilitation, analytical, and interpersonal skills.
- Proficient with PC tools (PowerPoint, Excel, Word, Outlook, etc.).
Compensation/Benefits:
- Estimated base salary: $129,000–$156,000.
- Comprehensive benefits package (eligibility per plan documents).
Application Instructions:
- If selected for an interview, speak with an HR partner about compensation philosophy and available benefits.