Quality Assurance Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

30d

About The Position

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.

Requirements

• Doctorate degree
• Master’s degree plus 2+ years of directly related experience
• Bachelor’s degree plus 4+ years of directly related experience
• Bilingual (English & Spanish).

Nice To Haves

• 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

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 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree