Biotech Manufacturing Operations & Quality Specialist

conexionlaboralsurestepr; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

conexionlaboralsurestepr seeks a Manufacturing Operations professional with advanced degrees and hands-on experience in biotech/pharma. The role emphasizesChange Controls, quality records management, and strong bilingual communication to support process development and quality assurance.

Ideal candidates will demonstrate progressive responsibility, proficiency with TrackWise/Vevaa and SAP, and excellence in technical writing and presentations in both English and Spanish.

Qualifications

• Doctorate or Master’s degree plus 2 years of Manufacturing Operations experience or Bachelor’s degree plus 4 years of Manufacturing Operations experience.
• Experience in manufacturing, process development, or quality assurance within biotech or pharmaceutical industry with increasing responsibility.
• Proficient in managing Change Controls and quality records (deviations, CAPAs, etc.) using systems like TrackWise, Vevaa, or similar.
• Strong communication skills (written and verbal) in English and Spanish, including technical writing and presentations.
• Manage Microsoft Office Tools and SAP (ERP) systems

Skills

Change controls

Quality records management

English/Spanish communication

Technical writing

MS Office

Education

Doctorate

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Tools

TrackWise

Vevaa

SAP (ERP)

Job description

conexionlaboralsurestepr seeks a Manufacturing Operations professional with advanced degrees and hands-on experience in biotech/pharma. The role emphasizesChange Controls, quality records management, and strong bilingual communication to support process development and quality assurance.

Ideal candidates will demonstrate progressive responsibility, proficiency with TrackWise/Vevaa and SAP, and excellence in technical writing and presentations in both English and Spanish.