Specialist Qa

Specialist QA
with expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
Skills:
Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
Validated experience as Quality Contact for sophisticated projects involving new drug substances /products with experience in commissioning, facility, utility, and equipment qualifications.
Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
Requirements:
Doctorate degree or Master's degree and 3 years of directly related experience or
Bachelor's degree and 5 years of directly related experience years of directly related experience (Sciences or Engineering)
Bilingual (Spanish/English)(Write/Speak)
Computer Literacy
?
Job Types: Full-time, Contract
Schedule:
8 hour shift
Day shift
Overtime
Education:
Bachelor's (Preferred)
Experience:
Quality Systems: 5 years (Preferred)
GxP applications: 5 years (Preferred)
validations: 5 years (Preferred)
Language:
Spanish (Preferred)
English (Preferred)
Work Location: In person