Job Description

Job Title: Quality Assurance Specialist
Location: Boston, MA (Hybrid)
Contract Duration: 12+ Months
Experience: 5+ years

We're looking for two experienced Senior Quality Assurance Specialists to support Quality and Compliance functions for ongoing development programs. This role is central to ensuring GMP compliance and maintaining product quality across the clinical lifecycle. The position requires a solid understanding of pharmaceutical quality systems, GMP principles, and hands-on experience in batch disposition and quality documentation review.

1. Batch Record Review & Product Disposition

• Review executed batch records, Certificates of Analysis (COAs), in-process control data, and stability results.

• Support timely and compliant disposition of drug substance, drug product, and finished goods from both internal and external manufacturing sites.

2. Quality Systems Management

• Support or lead investigations for deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) events.

• Conduct thorough root cause analyses and implement effective CAPAs.

• Manage change control processes, from assessment through implementation and closure.

3. Cross-Functional Collaboration

• Represent Quality Assurance on cross-functional project teams.

• Partner with groups including Pharmaceutical Sciences, Regulatory CMC, Supply Chain, and R&D Quality to ensure alignment and compliance.

4. Continuous Improvement

• Identify process gaps and drive initiatives that strengthen the Quality Management System (QMS).

• Recommend and implement improvements to documentation practices and quality procedures.

5. Documentation & Quality Agreements

• Draft, revise, and maintain GMP documents such as specifications, quality agreements, and standard operating procedures.

• Support audit readiness and ensure controlled document compliance across the organization and with contract manufacturers (CMOs).

• Bachelor's degree in a scientific or allied health discipline (or equivalent experience).

• Minimum 5 years of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology environment.

• Proven experience supporting batch disposition, deviation management, and CAPA implementation.

• Hands-on QA experience in analytical testing or manufacturing operations.

• Strong preference for candidates with small molecule manufacturing experience; exposure to biologics, devices, or gene therapy is a plus.

• Solid understanding of regulatory expectations (FDA, ICH, EMA) and cGMP principles across the product lifecycle.

• Demonstrated ability to lead investigations, perform risk assessments, and manage multiple quality systems simultaneously.

• cGMP compliance

• Batch record review

• CAPA and deviation management

• Root cause analysis (RCA)

• Change control

• Quality system documentation

• Cross-functional collaboration

• Continuous improvement

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