Quality Specialist- Non-Standard Shift

FITS LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS seeks a QA professional for the Drug Substance area, responsible for reviewing product MPs, approving validation protocols, and leading site audits in a dynamic pharmaceutical environment in Puerto Rico.

The role requires a Bachelor’s degree with 4 years' experience, bilingual English/Spanish, and strong project management skills; the candidate will own site quality procedures and support environmental and automation programs.

Qualifications

• Bachelor's degree with four years of experience in pharmaceutical or regulated industry.
• Bilingual English and Spanish.
• Project management skills.
• Experience in Quality and Manufacturing operations.
• Experience with batch record review, documentation compliance, electronic systems management, inventory control, and timely operations.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Coordinate with incident triage team for Quality.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems and approve planned incidents.
• Represent QA on NPI team.
• Lead investigations and site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support automation activities and facilities/environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Bilingual English & Spanish

Project management

Quality & Manufacturing ops

Batch Record Review

Education

Bachelor's Degree

Tools

Electronic systems management

Job description

For QA Services in the Drug Substancearea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with four(4)years of experiencewithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Non-Standardshift, and according to business needs.
• Experience in:
  • Quality and Manufacturing operations.
  • Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational.

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)

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems. Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations. Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities. Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

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?