Sr Specialist QA

fitspr; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS provides QA services within the Technical Team area, seeking a qualified individual with a Bachelor’s degree and 6+ years in the pharmaceutical or regulated industry. The role requires bilingual English/Spanish skills, project management, and experience across validation, risk/change control, and quality release activities.

Responsibilities include leading investigations, approving validation protocols, and representing QA on cross-functional teams, with shifts aligning to business needs in

Qualifications

• Bachelor's degree with 6+ years in pharmaceutical or regulated industry.
• Fluent in English and Spanish.
• Project Management experience.
• Shift: Administrative and per business needs.
• Experience in Facilities and Utilities Commissioning and Qualification.
• Experience in Computer System and Equipment Validation.
• Experience in Risk Assessments and Change Control.
• Knowledge of KNEAT, CDOCS, SCADA, TrackWise, Maximo.
• Document revision and approval.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Skills

Bilingual English/Spanish

Project management

Education

Bachelor's degree in pharmaceutical/regulatory field

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

For QA Services in the Technical Team area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with six(6)years of experiencewithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in:
  • Facilities and Utilities Commissioning and Qualification.
  • Computer System and Equipment Validation.
  • Risk Assessments and Change Control.
  • KNEAT, CDOCS, Scada, Trackwise, Maximo.
  • Documents revision and approval.

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)

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

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 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 industryclients with top-notch quality talent.We're FITS!

Are you the next piece?