Job Opportunities in United States
November 6, 2024
Professional Pharma Solutions
Juncos
CONTRACT & FULL TIME
Specialist QA
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Duties/Responsibilities:
Schedule:
Duties/Responsibilities:
- Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
- Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
- Experience with Validation of Gx P applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/Gx P 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 substance/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.
- Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
- Bachelor of Science with 5 or more years of directly related experience
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Quality systems: 5 years (Preferred)
- Electronic Systems (Cdocs,Maximo,Trackwise) etc: 5 years (Preferred)
- Bilingual (English/Spanish) (Preferred)
- Juncos, PR 00777 (Required)
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