QA Specialist | Pharmaceutical | Northern Region, PR

Location

Northern Region, Puerto Rico

Position Summary

The QA Specialist will provide operational, scientific, and compliance expertise to support sterile and non-sterile manufacturing operations within a pharmaceutical environment. This role will execute manufacturing investigations, coordinate the collection and evaluation of supporting information, and ensure the timely closure of quality events.

The specialist will collaborate with cross-functional teams to identify root causes, develop effective Corrective and Preventive Actions (CAPAs), and prevent recurrence while maintaining compliance with applicable regulatory requirements and site procedures.

Main Responsibilities

• Execute manufacturing investigations related to Quality Events (QEs), NTRs, and NOEs.

• Collect, coordinate, and assess information required to support thorough and scientifically sound investigations.

• Ensure QEs, NTRs, and NOEs are completed and closed within established timelines.

• Apply appropriate investigation and root cause analysis tools to identify causes and prevent recurrence.

• Prepare clear, accurate, and technically sound investigation reports and supporting documentation.

• Lead QE and CAPA trend evaluations to identify recurring issues and opportunities for improvement.

• Collaborate with Manufacturing, Quality, Engineering, and other relevant teams to develop effective corrective and preventive actions.

• Review and provide input to regulatory submissions within the assigned area of responsibility.

• Participate in regulatory inspections and support related activities as needed.

• Promote teamwork, accountability, and behaviors aligned with the organization’s values.

• Support site initiatives and additional assignments based on business needs.

General Requirements

• Strong knowledge of current Good Manufacturing Practices (cGMPs), OSHA, EPA, and other applicable regulatory standards.

• Understanding of manufacturing investigations, root cause analysis, and CAPA processes.

• Strong technical writing and presentation skills.

• Ability to interpret and analyze statistical data to support investigations and trend evaluations.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Excellent written and verbal communication skills in English and Spanish.

• Strong interpersonal skills and the ability to work effectively with cross-functional teams.

• Ability to manage multiple investigations and priorities while meeting established deadlines.

• Strong attention to detail and a commitment to documentation accuracy and regulatory compliance.

Education and Experience Requirements

• Bachelor’s degree in Science, Pharmacy, or Engineering.

• Minimum of five (5) years of experience in a parenteral manufacturing facility.

• At least one (1) year of experience executing manufacturing or quality investigations.