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QA Specialist

Flexible & Integrated Technical ServicesJuncos, Puerto Rico
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Overview

Schedule
Alternate-schedule
Full-time
Career level
Senior-level
Remote
On-site
Benefits
Health & Wellness Programs

Job Description

For Manufacturing Services in the Quality Systemsarea.

WHAT MAKES YOU A FIT: 

The Technical Part:

Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Shift: 12 hour shift 5pm-5:30 am and according to business needs.
  • Experience in:
    • Performing batch record (EBR) review, approval, and reconciliation.
    • Oversight manufacturing operations, Manage events and decision making.

    • 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 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! 

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    FAQs About QA Specialist Jobs at Flexible & Integrated Technical Services

    What is the work location for this position at Flexible & Integrated Technical Services?
    This job at Flexible & Integrated Technical Services is located in Juncos, Puerto Rico, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
    What pay range can candidates expect for this role at Flexible & Integrated Technical Services?
    Employer has not shared pay details for this role.
    What employment applies to this position at Flexible & Integrated Technical Services?
    Flexible & Integrated Technical Services lists this position under the following employment categories:
    • Alternate-schedule
    • Full-time
    What experience level is required for this role at Flexible & Integrated Technical Services?
    Flexible & Integrated Technical Services is looking for a candidate with "Senior-level" experience level.
    What benefits are offered by Flexible & Integrated Technical Services for this role?
    Flexible & Integrated Technical Services offers Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
    What is the process to apply for this position at Flexible & Integrated Technical Services?
    You can apply for this role at Flexible & Integrated Technical Services either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.