Job Title: Quality Assurance Specialist (3582305)

Location: Juncos, PR

Job Summary

Our client is seeking a Quality Assurance Specialist to support its Quality Assurance program under minimal supervision. The selected candidate will play a critical role in ensuring compliance with regulatory requirements, supporting validation activities, and driving quality systems across manufacturing operations.

Preferred Qualifications

• Degree in Science or Engineering.
• Experience in equipment, automation, and validation within regulated environments.
• Hands-on experience with change control processes.
• Familiarity with systems such as PASx/MES, MAXIMO, SAP, and LIMS.

Key Responsibilities

• Review and approve Master Production Records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Serve as Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support release of sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead deviation investigations and ensure timely closure.
• Lead and support site audits and regulatory inspections.
• Own and maintain site quality program procedures.
• Act as designee for QA Manager on local CCRB (Change Control Review Board).
• Review and approve risk assessments.
• Support automation, facilities, and environmental programs.
• Review and approve work orders and EMS/BMS alarms.
• Approve non-conformance investigations and CAPA records.
• Review and approve change controls.
• Perform lot disposition and authorize product release for shipment.

Education Requirements

Requirements:

-Doctorate OR

-Masters + 2 years of experience in Equipment and Validation process OR

-Bachelors + 4 years of experience in Equipment and Validation process OR

-Associates + 8 years of experience in Equipment and Validation process OR

-High school/GED + 10 years of dexperience in Equipment and Validation process

Core Competencies & Skills

• Strong project management and organizational skills with the ability to drive tasks to completion.
• Proven ability to lead cross-functional teams and influence stakeholders.
• Advanced knowledge of GMP, QA systems, validation, and process development.
• Experience interacting with regulatory agencies.
• Excellent communication, facilitation, and presentation skills (written and verbal).
• Strong analytical skills, including data trending and compliance evaluation.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and databases.
• Ability to work independently and collaborate effectively across all organizational levels.

Project Details

• Work Schedule: 100% onsite (Administrative Shift)
• Open Positions: 2
• Duration: 1-year contract

If you are interested in this opportunity, we invite you to apply through the job description link and submit your most updated resume. We look forward to connecting with you!