For Quality Assurance services in theDrug Substance area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degreewith five 5 years of direct experience as a Quality Professional in the regulated industry.
- Bilingual (English & Spanish)
- Project Management skills
- Shift: Administrativeand according to business needs.
- Experience in:
- Warehouse and Incoming QC operations.
- Quality oversightsincludeDeviations CAPAS Change Controls Temperature alarms etcand data integrityconcepts.
The Personality Part:
- Being selfmotivated means that you are curious anxious to explore all possibilities without anyone telling you to (while also following instructions of course). It means youre creative with such an eye for detail that nothing gets past you. If this sounds like you and if you have a commitment to serving customers with highquality research and products to embracing a diverse work culture and even to the environment you might just be what were looking for!
AS A PIECE OF FITS YOU WILL: (The daytoday on the job)
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on the incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on the NPI team.
- Lead investigations.
- Lead site audits.
- Ownsite quality program procedures.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!. Our company is flexible familyoriented and focused on our resources wellbeing while providing our Pharmaceutical Medical Device and Manufacturing industryclients with topnotch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC