Quality Specialist- 02

Flexible & Integrated Technical Services, LLC • Juncos, PR

2d • Onsite

About The Position

This role is for a Quality Specialist within the Drug Substance area, focusing on QA Services. The position requires a blend of technical expertise and interpersonal skills, emphasizing teamwork, ethical conduct, and the scientific method in a pharmaceutical or regulated industry setting.

Requirements

• Bachelor's Degree with four (4) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Quality organization supporting deviations, validation reports, qualifications, investigations.

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.

What This Job Offers

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