Specialist QA Release

Role Summary

Location: Cambridge, US. This is a full-time Specialist QA Release role. The specialist within QA Release is responsible for timely and compliant review of manufacturing and testing documentation to support the release of investigational and commercial drug products. As part of the batch record review and release team, operative tasks are performed following cGMP, internal procedures and applicable regulatory requirements. This role ensures that executed batch records, associated deviations, investigations, and supporting quality documentation are complete, accurate and approved prior to disposition decisions. The specialist works cross-functionally with other quality assurance teams, quality control, supply chain, distribution and more. This position plays a critical role in ensuring product quality, patient safety, and uninterrupted supply.

Responsibilities

• Perform independent, detailed review of executed batch production (i.e., drug substance, drug product, Linker-Payload, monoclonal antibodies, packaged finished IMP, packaged finished commercial products) and testing records. Verify compliance with cGMP, approved procedures and regulatory requirements.
• Verify compliance with complete product lifecycle supply chain
• Ensure all manufacturing and laboratory activities were performed as approved, documented, contemporaneously, and accurately recorded with appropriate reconciliation of materials, yields, and critical process parameters.
• Ensure that all required quality documentation is accurate, approved and archived in accordance with data integrity principles (ALCOA+).
• Support batch disposition decisions by confirming all quality events are resolved and closed prior to batch release.
• Identify recurring documentation or process issues and escalate trends or compliance risks in accordance with established quality systems.
• Participate in continuous improvement initiatives related to batch record review, process, systems, and documentation practices.
• Support greater quality assurance team with cross training on operative tasks related to post release operative tasks (i.e. supply and distribution oversight)

Qualifications

• Required: Bachelor's degree in scientific or technical discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences, Engineering) or equivalent combination of education and relevant industry experience.
• Required: Minimum of 1-3 years’ experience in a regulated pharmaceutical, biotechnology, or life science environment performing activities under cGMP.
• Required: Ability to perform independent, detail-oriented reviewed to identify documentation errors, discrepancies, and compliance risks.
• Required: Working knowledge of current Good Manufacturing Practice (cGMP) regulations, including FDA requirements applicable to drug substance and/or drug product manufacturing.
• Required: Knowledge of data integrity principles (ALOCA+) and expectations for contemporaneous, accurate, and complete documentation.
• Required: Proficiency in electronic quality systems and document management systems (i.e., QMS, LIMS, SAP).
• Required: Experience working cross functionally across many different departments to resolve quality and documentation issues.
• Required: Strong written and verbal communication skills, with the ability to clearly document rationale and communicate quality concerns.
• Required: Ability to work in a fast-paced, regulated environment while meeting timelines and maintaining compliance.
• Preferred: Prior experience in supporting release of clinical and/or commercial material.
• Preferred: Familiarity with ICH guidelines (Q7, Q9, Q10) and 21 CFR 211.