QA Specialist | Pharmaceutical | Northern Region, PR

Legalpmpartners; Barceloneta (PR); Sur place; USD 62 000 - 83 000; Temps partiel

Résumé du poste

Legalpmpartners in Puerto Rico is seeking a QA Specialist to provide operational, scientific, and regulatory compliance support for sterile and non-sterile pharmaceutical manufacturing. The role focuses on investigations, CAPAs, and timely closure of quality events.

You will lead root-cause analyses, collaborate with Manufacturing, Quality, Engineering, and other teams, and contribute to regulatory submissions and inspections.

Qualifications

• Bachelor’s degree in Science, Pharmacy, or Engineering.
• Minimum of five years in a parenteral manufacturing facility.
• At least one year executing manufacturing or quality investigations.
• Experience with cGMPs and regulatory standards.

Responsabilités

• Execute manufacturing investigations related to Quality Events (QEs), NTRs, and NOEs.
• Collect, coordinate, and assess information required to support investigations.
• Ensure QEs, NTRs, NOEs are completed and closed within established timelines.
• Apply investigation and root cause analysis tools to identify causes and prevent recurrence.
• Prepare clear, accurate investigation reports and supporting documentation.
• Lead QE and CAPA trend evaluations to identify recurring issues.
• 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.

Connaissances

cGMP knowledge

Regulatory understanding

Technical writing

Presentation skills

Bilingual English/Spanish

Formation

Bachelor’s degree (Science/Pharmacy/Engineering)

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

QA Specialist | Pharmaceutical | Northern Region, PR

Contractor - 1099 Professional ARECIBO, PR, 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.