Quality Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d • Onsite

About The Position

For QA Services in the Downstream area. This role requires a Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry. The ideal candidate will be bilingual (English & Spanish) and possess strong Project Management skills. The position operates on an administrative shift, adaptable to business needs. Experience in NPI, Change Control, FATs, Validation, and PPQs is essential. The role is situated in a lab environment that encourages multitasking, scientific rigor, creativity, healthy competition, teamwork, ethical conduct, and the application of the scientific method.

Requirements

• Bachelor's Degree
• Five (5) years of experience within the pharmaceutical or regulated industry
• Bilingual (English & Spanish)
• Project Management skills
• Experience in NPI, Change Control, FATs, Validation, and PPQs

Nice To Haves

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

Responsibilities

• 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.

Benefits

• Flexible scheduling
• Family-oriented environment
• Focus on employee well-being

What This Job Offers

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