Specialist Quality Assurance
About The Position
This Specialist Quality Assurance role is for QA Services in the Downstream area. The position requires a Bachelor's Degree and five years of experience in the pharmaceutical or regulated industry, along with bilingual proficiency in English and Spanish and Project Management skills. Key experience areas include Quality Systems (Deviations, CAPA, Change Control), various documentation and enterprise platforms (CDOCS, Maximo, TrackWise, LIMS, MES/electronic batch record systems, SAP), computer systems validation (CSV) or computer systems quality assurance, and GxP application validation, including Validation Master Plans, GxP risk assessments, and IQ/OQ/PQ protocols. The ideal candidate is described as someone who thrives in a lab environment, demonstrating multitasking, scientific, and creative skills, while valuing healthy competition, teamwork, ethical conduct, and the scientific method. The hiring company is a Service Provider that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services, focusing on providing top-notch talent to Pharmaceutical, Medical Device, and Manufacturing industry clients across the Island and in the US. The company prides itself on being flexible, family-oriented, and dedicated to its resources' well-being.
Requirements
- Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Experience in Quality Systems, including Deviations (Nonconformities), CAPA, and Change Control.
- Experience in Documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
- Experience in Computer systems validation (CSV) or computer systems quality assurance.
- Experience in Validation of GxP applications, including Validation Master Plans, GxP risk assessments, and IQ/OQ/PQ protocols.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
11-50 employees
