QA Analyst: CAPA, Change Control & Risk in Biopharma

Kelly Services; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom (SETT) seeks a Quality Assurance Analyst to support a top biopharmaceutical client in the Barceloneta, PR area. You will lead CAPA, change control, and risk management activities and ensure regulatory compliance across quality programs.

Responsibilities include monitoring KPIs, driving timely corrective actions, maintaining databases, and presenting analyses for quality reviews. Strong English and Spanish communication is required.

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.
• Knowledge of data processing system and analytical capability with strong written and verbal communication in English and Spanish.

Responsibilities

• Monitor KPIs for CAPA, Change Control and Risk Management and ensure timely actions.
• Lead reviews of actions to confirm proper definition and timely completion, and assess trends to prevent issues.
• Maintain databases for tracking and trending of quality actions and investigations.
• Facilitate meetings to triage events and ensure CAPA reviews are documented and effective.
• Provide information and analysis for Annual Quality Reviews and related meetings.
• Perform statistical analysis of exception documents and identify root causes for corrective actions.

Skills

Quality assurance

CAPA

Change Control

Risk Management

Education

Bachelor's degree in Natural Sciences

Job description

Kelly Science, Engineering, Technology & Telecom (SETT) seeks a Quality Assurance Analyst to support a top biopharmaceutical client in the Barceloneta, PR area. You will lead CAPA, change control, and risk management activities and ensure regulatory compliance across quality programs.

Responsibilities include monitoring KPIs, driving timely corrective actions, maintaining databases, and presenting analyses for quality reviews. Strong English and Spanish communication is required.