For QA services in the IT and Automation Systems area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s degree in Sciences or Engineering with five (5) years in the regulated industry.
- Bilingual (English & Spanish)
- Project Management skills
- Shift: Administrative and according to business needs.
- Experience in:
- Design Qualification and Reviews. Revising validation/commissioning, and technical documentation.
- Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control) and Risk Assessment.
- Validation (IQ), (OQ), and (PQ) Protocols. Computer Systems Validation (CSV).
- Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Evaluate relevant documentation compliance such as CR’s, SOP’s, BR’s, BOM’s, WPP’s, URS, qualification and validation Protocols.
- Review/Approve equipment/facilities/system validation documents such as System Level Impact Assessment (SLIA), (CCA), (SR), (DQ), (RA), (RAA).
- Review/approve the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing/laboratory.
- Review/approve test script and manage revision/approval of any deviations occurring during the project’s implementation stage.
- Review/approve impacted procedures related to process, products, utilities, and laboratories, and ensures compliance of all procedures.
- Review/approve generated Revalidation Plans.
- Support risk analysis process when a quality event has happened that cannot be solved immediately.
- Manage audit observation, investigations, change control and CAPAs records in Infinity System on timely manner.
- Participate in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings.
- Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.)
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?
Top Skills
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]
