Quality Analyst I: CAPA, Change Control & Risk

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 55,000 - 85,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an Associate Quality Analyst I to lead quality processes and manage nonconformance, CAPA, Change Control and Risk Management in a pharma/biotech environment.

The role requires strong analytical abilities, proficiency in MS Office, and effective communication in English and Spanish. Experience with cGxP and regulatory guidance is preferred. Flexible hours may be required in a quality-centric setting.

Qualifications

• Bachelor’s degree in Natural Sciences, preferably Biology, Chemistry or related field.
• Experience in a Quality or technical field in the Pharmaceutical or Biotechnological industry preferred.
• Quality/compliance management skills as well as regulations and standards.

Responsibilities

• Monitor KPIs for CAPA, Change Control, and Risk Management.
• Ensure timely completion of actions in quality records and programs.
• Lead actions review to ensure timely completion and root-cause investigation.
• Maintain databases for tracking and trending of actions.

Skills

CAPA knowledge

Change control

Regulatory compliance

Analytical skills

MS Office

Education

Bachelor's degree in Natural Sciences

Job description

Validation & Engineering Group, Inc. seeks an Associate Quality Analyst I to lead quality processes and manage nonconformance, CAPA, Change Control and Risk Management in a pharma/biotech environment.

The role requires strong analytical abilities, proficiency in MS Office, and effective communication in English and Spanish. Experience with cGxP and regulatory guidance is preferred. Flexible hours may be required in a quality-centric setting.