Quality Assurance Specialist – Manufacturing & Validation

About the role

We are seeking an experienced Quality Assurance Specialist to support our client’s manufacturing and validation activities in Puerto Rico. The role involves ensuring regulatory compliance, overseeing process validation, and maintaining high‑quality standards across all production operations.

Key responsibilities

• Support the Quality Assurance program with minimal supervision.
• Review, approve, and release technical documents such as reports, procedures, and forms.
• Approve product manufacturing procedures (MPs) and process validation protocols and reports.
• Participate in incident triage, environmental characterization, and sanitary utility system releases.
• Represent QA on New Product Introduction (NPI) teams and perform investigations, audits, and risk assessments.
• Own site quality program procedures and act as designee for the QA manager on the local CCRB.
• Support automation, facilities, and environmental programs, including work order approvals.
• Approve non‑conformance investigations, CAPA records, and change controls.

Required profile

• Minimum 5 years of experience in a highly regulated biopharmaceutical environment.
• Background in quality organization activities such as deviations, validation reports, qualifications, and investigations.
• Education: Doctorate or Master’s degree with 2 + years related experience, Bachelor’s with 4 + years, Associate’s with 8 + years, or High School/GED with 10 + years of relevant experience.

Required skills

• Technical writing and document review.
• Process validation and regulatory compliance.
• CAPA (Corrective and Preventive Action) management.
• Risk assessment and mitigation.
• Automation support for quality processes.
• Facilities and environmental program support.