SUMMARY:

We are seeking a detail-oriented and proactive QA Specialist to join our dynamic biotechnology team. This role is critical in ensuring compliance with regulatory standards and internal quality systems, particularly in areas involving change control, aseptic manufacturing, and validation activities. The ideal candidate will bring hands-on experience in GMP environments and contribute to continuous improvement initiatives across the organization.

Main Responsibilities:

• Oversee and manage change control processes, ensuring timely review, impact assessment, and implementation in accordance with regulatory and internal requirements.
• Support and monitor aseptic processing operations, including routine audits, environmental monitoring reviews, and contamination control strategies.
• Lead and/or support validation activities (equipment, process, cleaning, and computerized systems), including protocol development, execution, and final reporting.
• Review and approve quality documentation such as SOPs, batch records, deviations, CAPAs, and validation protocols.
• Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and R&D to ensure quality objectives are met.
• Participate in internal and external audits, including regulatory inspections (FDA, EMA, etc.), and support audit readiness.
• Analyze quality metrics and trends to identify areas for improvement and drive corrective/preventive actions.
• Maintain current knowledge of applicable regulations, standards, and industry best practices (e.g., FDA, ICH, ISO, EU GMP).

Requirements:

• Education: Bachelor’s degree in Science, Engineering, or related life sciences field.
• Experience: Minimum 3–5 years in QA roles within biotechnology, pharmaceutical, or medical device industries.
• Strong knowledge of GMP, aseptic techniques, change control systems, and validation lifecycle.
• Excellent written and verbal communication skills; bilingual proficiency (English/Spanish) is a plus.
• Analytical mindset, attention to detail, problem-solving ability, and collaborative spirit.

Work Methodology:

• Professional services contract
• Full time
• Administrative shift with availability to support non administrative hours
• 6-12 months of first contract with potential extensions based on performance and budget
• Languages: Spanish and English
• Location: Juncos, PR

• Oversee and manage change control processes, ensuring timely review, impact assessment, and implementation in accordance with regulatory and internal requirements.
• Support and monitor aseptic processing operations, including routine audits, environmental monitoring reviews, and contamination control strategies.
• Lead and/or support validation activities (equipment, process, cleaning, and computerized systems), including protocol development, execution, and final reporting.
• Review and approve quality documentation such as SOPs, batch records, deviations, CAPAs, and validation protocols.
• Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and R&D to ensure quality objectives are met.
• Participate in internal and external audits, including regulatory inspections (FDA, EMA, etc.), and support audit readiness.
• Analyze quality metrics and trends to identify areas for improvement and drive corrective/preventive actions.
• Maintain current knowledge of applicable regulations, standards, and industry best practices (e.g., FDA, ICH, ISO, EU GMP)