Sr. Specialist QA
Flexible & Integrated Technical Services, LLC
- Juncos, PR
- Permanente
- Tiempo completo
- Bachelor’s degree in Business Administration, Material Management, Science or Engineering with six (6) years of directly related experience in the Pharmaceutical or Medical Device industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative and according to business needs.
- Experience in:
- Equipment qualification and computer systems qualification.
- If Quality is your middle name, keep reading! We’re looking for a passionate QA who likes to finish what they started and is confident in their ability to succeed. Sprinkle on a love of the scientific method, teamwork and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!
- In support of Quality Assurance program acts as the technical specialist.
- Review and approve product MP’s.
- Approve process validation protocols and reports for mfg. Processes.
- Represent Quality on incident triage team.
- Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.