Quality Assurance Specialist

Weil Group • Manati, PR

17d

About The Position

We are seeking an experienced Quality Assurance Specialist to join our pharmaceutical manufacturing team. This role requires a technical professional with deep expertise in GMP compliance, computerized systems validation, and pharmaceutical quality operations.

Requirements

• Bachelor’s degree in science (Chemical Engineering, Engineering, Biology, Pharmacy, or Microbiology)
• Minimum 6 years of Quality Assurance experience in the pharmaceutical industry
• Proven background in pharmaceutical products manufacturing environment
• Hands-on experience with computerized systems validation
• Proven background in pharmaceutical products manufacturing environment
• Hands-on experience with computerized systems validation
• Fully bilingual (Spanish/English) - written and verbal communication required
• Self-motivated with strong initiative and creative problem-solving abilities
• Team-oriented with excellent interpersonal skills
• Technical and scientific capability to make firm decisions and recommendations
• Effective communication skills across all organizational levels
• Strong sense of urgency and analytical thinking
• Ability to work irregular hours, rotative shifts, weekends, and holidays when needed

Responsibilities

• Ensure compliance with FDA, GMP, 21 CFR Part 11, EU regulations, and Data Integrity requirements
• Conduct risk assessments and data mapping activities
• Lead and support computerized systems validation initiatives using GAMP5 methodology
• Review and approve validation/commissioning and technical documentation
• Collaborate with cross-functional teams to maintain quality standards
• Utilize quality management systems (TrackWise/Infinity) and enterprise software (SAP)
• Support investigations, CAPAs, and continuous improvement initiatives
• Provide technical guidance and recommendations on quality matters

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees