For Deviation in the Quality Systems area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree with two (2) years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative and according to business needs.
- Experience in:
- Deviation management within a GMP/GxP environment, ownership of major and minor deviations.
- Investigation lifecycle from initiation through closure.
- Computerized manufacturing systems, including platforms such as MES, Veeva, SAP, PCS, or PI Historian.
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)
- Responsibility extends to multiple departments/functional areas.
- Demonstrates thorough knowledge of objectives and processes in multiple departments/functional areas supported.
- Promotes and develops communication between assigned business unit, technical staff, and vendors to integrate information systems.
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations.
- Conducts impact analysis of new products, systems, upgrades, and changes for multiple departments/functional areas.
- Evaluates systems and business processes for feasibility in multiple departments/functional areas. Able to recognize problems and communicate.
- Establishes and maintains positive business relationships with managers and staff in multiple departments/functional areas.
- Has a thorough understanding of the client?s business, their processes, and their priorities.
- Ensures system functionality and performance meet current and future business requirements. May apply principles, theories and concepts.
- Prepares complex documentation for assigned projects. (Refer to Project Deliverables, Appendix 1).
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 with two years' experience as a Scientist in pharmaceutical or regulated industry.
- Bilingual English and Spanish.
- Project management skills.
- Availability for administrative shift work according to business needs.
- Experience in deviation management within a GMP/GxP environment, ownership of major and minor deviations.
- Experience managing the investigation lifecycle from initiation through closure.
- Experience with computerized manufacturing systems (MES, Veeva, SAP, PCS, PI Historian).
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]
