Position Overview
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.

Key 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

Required Qualifications
Education
- Bachelor’s degree in science (Chemical Engineering, Engineering, Biology, Pharmacy, or Microbiology)

Experience
- 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

Language Requirements
- **Fully bilingual (Spanish/English)** - written and verbal communication required

Core Competencies
- 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

**Weil Group is proud to be an Equal Employment Opportunity Employer.**