Sr Specialist QA

Flexible & Integrated Technical Services, LLC • Juncos, PR

8d • Onsite

About The Position

For QA Services in the Technical Team area. 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!

Requirements

• Bachelor's Degree with six (6) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Facilities and Utilities Commissioning and Qualification.
• Experience in Computer System and Equipment Validation.
• Experience in Risk Assessments and Change Control.
• Experience with KNEAT, CDOCS, Scada, Trackwise, Maximo.
• Experience in Documents revision and approval.

Nice To Haves

• Multitasking skills
• Scientific skills
• Creative skills
• Teamwork
• Ethical conduct
• Use of the scientific method

Responsibilities

• 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.

Benefits

• Flexible
• Family-oriented
• Focused on resources' well-being

What This Job Offers

• Job Type: Full-time
• Career Level: Senior