Quality Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

8d • Onsite

About The Position

For QA Services in the Drug Substance area. This role requires a Bachelor's Degree with four (4) years of experience within the pharmaceutical or regulated industry. The position involves a bilingual requirement (English & Spanish) and strong Project Management skills. The shift is administrative, with flexibility according to business needs. The role focuses on validations, commissioning & qualifications of manufacturing equipment and laboratory, technical writing, quality systems (deviations, change control), and maintenance tasks. The ideal candidate will possess strong multitasking, scientific, and creative skills, thrive in a competitive and team-oriented environment, and adhere to ethical practices and the scientific method.

Requirements

• Bachelor's Degree with four (4) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Validations and Commissioning & Qualifications of manufacturing equipment and laboratory.
• Experience in Technical Writing, Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval).
• Experience in Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.

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