Specialist QA

For QA services in the IT and Automation Systemsarea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors degree in Sciences or Engineering with five(5) yearsin the regulated industry.
• Bilingual (English & Spanish)
• Project Management skills
• Shift: Administrativeand 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 youre 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 were looking for!

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

• Evaluate relevant documentation compliance such as CRs SOPs BRs BOMs WPPs 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 projects 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 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 family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece