Senior QA Specialist – GMP Biotech (Onsite)

Artech-Information-Systems-L.l.c.; Barceloneta (PR); On-site; USD 50,000 - 57,000; Full time

Job summary

Artech-Information-Systems-L.l.c. seeks a QA Specialist III / Senior Quality Analyst to implement and maintain the Quality System and support manufacturing operations in event resolution, impact assessment, and documentation discrepancies.

Experience in GMP, CAPA investigations, risk assessment, and regulatory guidelines is required. Bilingual English/Spanish and a degree in biotechnology or related field are preferred; masters are a plus. Onsite in Barceloneta, PR.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP, safety regulations.
• Excellent written and spoken communication skills in English and Spanish.
• Quality/compliance management skills.

Responsibilities

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with Client policies and applicable regulations for the Quality areas under responsibility.
• Serve as backup for the QA Manager leading the team and providing support to quality initiatives.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents. Ensures all documents are in compliance with Client global procedures and regulatory requirements.

Skills

Fully bilingual

Teamwork

Time management

Education

Bachelor’s degree in Biotechnology, Biology, Chemistry or Engineering

Master's degree in Science preferred

Job description

Artech-Information-Systems-L.l.c. seeks a QA Specialist III / Senior Quality Analyst to implement and maintain the Quality System and support manufacturing operations in event resolution, impact assessment, and documentation discrepancies.

Experience in GMP, CAPA investigations, risk assessment, and regulatory guidelines is required. Bilingual English/Spanish and a degree in biotechnology or related field are preferred; masters are a plus. Onsite in Barceloneta, PR.