Quality Systems Specialist - CAPAs And Deviations

Job Title:

Quality Systems Specialist - CAPAs and Deviations

Job Description

The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, with a primary focus on managing corrective and preventive actions (CAPAs) and deviations. This role executes and maintains key quality processes, including GMP training programs, validation and qualification document review, investigations, change controls, and CAPAs. The specialist collaborates cross‑functionally to ensure adherence to quality system procedures, supports continuous improvement initiatives, and helps maintain regulatory compliance and product quality through effective governance of quality systems.

Responsibilities

* Oversee the CAPA system on a daily basis, including tracking actions, monitoring progress, and driving timely closure of CAPAs.

* Initiate, review, and manage deviations, ensuring accurate documentation, appropriate impact assessment, and effective follow‑up actions.

* Request and manage CAPA and deviation extensions when necessary, ensuring clear justification and compliance with internal procedures.

* Execute and maintain cGMP quality system processes, including GMP training programs, validation and qualification document review, and change controls.

* Review quality documentation such as validation and qualification records, change control records, and batch records to ensure accuracy, completeness, and compliance.

* Support and participate in internal audits, contributing to audit preparation, execution, and follow‑up activities.

* Support external audit readiness by maintaining compliant quality systems, documentation, and training records.

* Manage and maintain training documentation, ensuring that training records are accurate, up to date, and aligned with GMP requirements.

* Contribute to the preparation of Annual Product Reviews (APRs) and support change control governance activities to maintain regulatory compliance.

* Collaborate cross‑functionally with manufacturing, quality control, and other departments to resolve quality issues and drive continuous improvement.

* Support continuous improvement initiatives within the quality management system, identifying opportunities to enhance processes and compliance.

* Ensure quality system activities comply with FDA regulations, cGMP requirements, and internal quality policies and procedures.

* Perform document control activities as needed, ensuring controlled documents are properly reviewed, approved, and maintained within the quality management system.

Essential Skills

* Bachelor's degree or above in a scientific discipline.

* At least 2 years of Quality Assurance or Quality Systems experience in the biopharmaceutical or pharmaceutical industry.

* At least 2 years of experience working with CAPAs and deviations in a regulated environment.

* Demonstrated experience with cGMP quality systems, including investigations, deviations, CAPAs, and change controls.

* Working knowledge of FDA regulations and compliance expectations for biopharmaceutical or pharmaceutical manufacturing.

* Experience with quality management systems and quality system procedures in a GMP environment.

* Ability to review and interpret quality documentation, including validation and qualification documents, training records, and batch records.

* Strong attention to detail and accuracy in documentation and record keeping.

* Ability to collaborate effectively with cross‑functional teams and communicate clearly in a regulated environment.

Additional

Skills & Qualifications

* Experience with internal audits and familiarity with internal and external audit processes.

* Exposure to or experience with quality auditing and audit preparation activities.

* Experience with document control processes and systems within a quality management framework.

* Experience reviewing batch records and related GMP documentation.

* Familiarity with Annual Product Review (APR) preparation and change control governance.

* Demonstrated ability to support continuous improvement initiatives within quality systems.

* Strong organizational skills and the ability to manage multiple CAPAs, deviations,…