Quality Assurance Analyst

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

At Kelly® Science, Engineering, Technology & Telecom (SETT),we’re passionate about helping you find a job that works for you. How about this one? We’re seeking an Quality Assurance Analyst to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it’s all about finding the job that’s just right

Purpose:

Describes the primary goals, objective or function or outputs of this position. Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management.

Responsibilities:

• Monitor performance through appropriate Key Performance Indicators (KPIs) for CAPA, Change Control, and Risk Management. Ensure a timely completion of actions identified in: Exception Reporting System, Change Management or Risk Management quality records and programs.
• Provide leadership to ensure that actions are properly reviewed in order to ensure appropriate definition and timely completion of actions and review of significant trends/issues to prevent regulatory liabilities and financial losses. Evaluate if actions were effective and verified after implementation. Confirm that actions do not adversely affect the finished product.
• Maintain the required databases necessary for tracking and trending to ensure actions are implemented and documented.
• Facilitate meetings to ensure timely identification and management of events, including but not limited to triage and CAPA review board. Drive dialogue and discussion to ensure non-conformances are appropriately documented in a timely manner and that – when required – investigations are timely, rigorous and drive to root cause to facilitate the identification and implementation of effective corrections, corrective and preventive actions.
• Provide in a timely manner information and analysis required for the Annual Quality Reviews, among other meetings.
• Review and perform statistical analysis of all exception documents by reasons (re-inspections, NCR, Deviations and associated formal investigations). Correlate information and summarize it with the corresponding corrective actions. Identify if there are trends indicating the need for changes manufacturing or control procedures.

Experience Requirements:

This position requires knowledge in: quality / compliance management, visual inspection AQL and operator certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications.

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.
• Position requires computer literacy to manage multiple computer programs and databases.
• Knowledge of data processing system, analytical competence, good verbal and written communication skills in both languages, English and Spanish.
• Prior experience in CAPA, Change Control, and/or Risk Management is preferred.