QA Specialist – ProQN-669

About the role

We are seeking a QA Specialist to join our client’s Quality Assurance team in Juncos, Puerto Rico. The role provides on‑the‑floor QA support, ensures cGMP compliance, and collaborates with cross‑functional groups to maintain product quality and regulatory standards.

Key responsibilities

• Perform Plant Quality Assurance (PQA) reviews, approvals, and tracking of cGMP processes, procedures, testing methods, manufacturing documentation, records, and batch records.
• Work with quality and manufacturing systems such as MES, EBR, SAP, EDMQ, DQMS, and TrackWise.
• Review and approve product manufacturing procedures and process validation protocols.
• Lead incident triage, investigations, deviations, non‑conformances, and CAPA records.
• Verify production records and testing results for completeness, accuracy, and cGMP compliance.
• Approve environmental characterization reports, lot disposition, and release of sanitary utility systems.
• Represent QA on New Product Introduction (NPI) teams and cross‑functional projects.
• Support internal and external audits, site audits, and serve as QA designee on the Change Control Review Board.

Required profile

• Bachelor’s degree in Science or Engineering.
• Minimum of 4 years of directly related QA experience in a regulated manufacturing environment.
• Ability to work non‑standard shifts, including weekends, as business needs dictate.

Required skills

• cGMP knowledge and application.
• Experience with MES, EBR, SAP, EDMQ, DQMS, and TrackWise systems.
• Proficiency in reviewing and approving manufacturing procedures, validation protocols, and change controls.
• Strong investigative skills for deviations, non‑conformances, and CAPA.
• Familiarity with environmental characterization, lot disposition, and sanitary utility release processes.