Specialist QA
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Oversee the site Quality Assurance program by ensuring compliance with cGMP, regulatory standards, and internal quality systems across manufacturing, environmental monitoring, and validation. Review and approve product master production records, work orders, nonconformance investigations, and change controls while providing lot disposition and authorizing shipments. Lead investigations, site audits, and risk assessments for GMP operations, then present EM/CU data and recommendations during management review meetings. Alert senior management of quality, compliance, supply, and safety risks to drive continuous improvement initiatives. Fully bilingual in English and Spanish with a doctorate or equivalent experience required.
Required Qualifications
- Doctorate
- Master's + 2 years directly related experience
- Bachelor's + 4 years directly related experience
- Associate's + 8 years directly related experience
- High School/GED + 10 years directly related experience
- Strong knowledge of QA, QAL, validation, process development, and GMP manufacturing
- Advanced data trending, evaluation, and compliance issue assessment
- Experience in EM, Microbial Identification, CU monitoring, sampling techniques, and microbiological testing methods
- Understanding of aseptic behavior, facility cleaning/disinfection, and contamination control strategies
- Ability to interpret and apply regulatory requirements for cleanrooms and controlled environments
- Proficiency in Microsoft Office (Word, PowerPoint, Excel), Smartsheets, and data visualization tools
- Hands-on experience with electronic systems such as Veeva, Spotfire, LIMS, Maximo
- Ability to use statistical tools and AI/data analytics platforms to interpret EM/CU data
- Strong project management and organizational skills
- Ability to lead cross-functional teams, influence stakeholders, and negotiate effectively
- Strong written and oral communication skills; facilitation and presentation capabilities
- Fully bilingual in English and Spanish
- Demonstrated ability to interact with regulatory agencies
- Ability to work independently and collaborate across multiple levels of the organization
- Demonstrates strong leadership practices and quality mindset
Desired Qualifications
- Bachelor's or higher in Microbiology, Biology, Life Sciences, Engineering, Chemistry, Physics, or Computer Science
- 10+ years in biopharmaceutical industry with 5+ years in Quality
- Extensive experience in Quality & Compliance, regulatory audits, validation, characterization, and automation validation
- Strong background in reviewing/approving deviations, EM/CU trend reports, and contamination control documentation
- Ability to identify quality, compliance, supply, and safety risks and escalate appropriately
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.