For QA Services in the Downstream area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative shift, and according to business needs.
- Experience in:
- Environmental Monitoring, Microbial Identification, Critical Utilities, and Cleanroom Contamination Control.
- Quality Standards and Regulations (Annex 1, FDA Guidance, ISO - 14644-1, and USP.
- Data trending, statistical anlaysis, and electronic platforms (Veeva, Spotfire, LIMS, Maximo).
The Personality Part:
- Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems. Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations. Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities. Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- 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 company different from the rest. We pride ourselves in how we treat the most important piece of our company's 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, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
Skills Required
- Bachelor's Degree
- Five years of experience in pharmaceutical or regulated industry
- Bilingual in English and Spanish
- Project Management skills
- Experience in Environmental Monitoring, Microbial Identification, Critical Utilities, and Cleanroom Contamination Control
- Knowledge of Quality Standards and Regulations (Annex 1, FDA Guidance, ISO - 14644-1, USP)
- Experience in data trending and statistical analysis
- Familiarity with electronic platforms (Veeva, Spotfire, LIMS, Maximo)
What We Do
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's 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, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
