Biotech QA Specialist: Lead Investigations & Compliance

FITS LLC; Gurabo (PR); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

High-impact projects

Career growth

Job summary

FITS is seeking a QA Specialist to support a leading biotechnology manufacturer in Puerto Rico. You’ll be the Quality voice for manufacturing operations, approving records, leading investigations, and partnering with Manufacturing, Engineering, and Process Development.

Responsibilities include approving MPs, process validation protocols, CAPAs, change controls, and lot disposition, while leading site audits and cross-functional teams. Fluency in English and Spanish is required.

Qualifications

• PhD or equivalent with pharma/biotech QA experience.
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Responsibilities

• Review and approve product master production records (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on the incident triage team and approve planned incidents.
• Lead investigations and approve NC investigations and CAPA records.
• Approve change controls and serve as QA Manager’s designee on CCRB.
• Provide lot disposition and authorize lots for shipment.
• Represent QA on New Product Introduction (NPI) teams.
• Lead site audits and support interactions with regulatory agencies.
• Own site quality program procedures.
• Review risk assessments and evaluate compliance issues.
• Approve Environmental Characterization reports and support facilities programs.
• Release sanitary utility systems.
• Review and approve Work Orders and EMS/BMS alarms.
• Support automation activities.
• Perform advanced data trending and evaluation.
• Initiate and lead cross-functional teams with external resources.

Skills

Bilingual: English/Spanish

GDP knowledge

Electronic quality systems

Education

Doctorate

Master’s + 2+ years relevant experience

Bachelor’s + 4+ years relevant experience

Tools

TrackWise

SAP

Maximo

LIMS

MES

Job description

FITS is seeking a QA Specialist to support a leading biotechnology manufacturer in Puerto Rico. You’ll be the Quality voice for manufacturing operations, approving records, leading investigations, and partnering with Manufacturing, Engineering, and Process Development.

Responsibilities include approving MPs, process validation protocols, CAPAs, change controls, and lot disposition, while leading site audits and cross-functional teams. Fluency in English and Spanish is required.