Flexible & Integrated Technical Services, LLC

Quality Assurance Specialist

Pharmaceutical - Gurabo, Puerto Rico - Contracted

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.

Education requirements:
- 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, as needed by business.

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 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.

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.

Ready to be a Piece of FITS? Apply today!