Quality Systems Specialist

Job Title : Quality Systems Specialist

Location : Boston, MA (Hybrid)

Contract Duration : 12+ Months

Experience : 5+ years

Overview

We're looking for two experienced Quality Systems Specialist s 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.

Key Responsibilities

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).

Minimum Qualifications

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.

Preferred Qualifications

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.

Core Skills

cGMP compliance

Batch record review

CAPA and deviation management

Root cause analysis (RCA)

Change control

Quality system documentation

Cross-functional collaboration

Continuous improvement