Quality Assurance Specialist

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

For QA Services in the Technical Team area.

What Makes You a Fit:

FITS is looking for a QA Specialist to support a leading biotechnology manufacturer. In this role, you’ll be the Quality voice for manufacturing operations. You will approve the records that keep product moving, lead investigations and audits, and partner closely with Manufacturing, Engineering, and Process Development.

• Educationrequirements:
  • a Doctorate
  • a Master’s plus 2+ years of directly related experience
  • a Bachelor’s plus 4+ years of directly related experience
• Bilingual (English & Spanish).
• Shift: Administrative, asneededbybusiness.

Preferred qualifications:

• GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures
• Experience supporting packaging/inspection operations
• Strong knowledge of GDP and electronic quality systems
• Ability to collaborate effectively with Manufacturing, Engineering, and Process Development

As a Piece of FITS You : (The day-to-day on the job)

• 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 investigationsand approve NC investigations and CAPA records
• Approve change controls and serve as the QA Manager’s designee on the local 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 and environmental 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, coordinating with higher-level outside resources.
• Work in electronic quality and manufacturing systems such as TrackWise, SAP, Maximo, LIMS, and MES.

Being a FITS Piece Comes With Perks

• Work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech and medical devices

Who We Are

FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a match that lasts.