Associate Quality Analyst I

Weil Group, Inc; Barceloneta (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Weil Group, Inc. seeks an Associate Quality Analyst to lead quality processes including nonconformance management, CAPA, Change Control, and Risk Management. You will monitor KPIs, drive timely action closure, and ensure investigations are rigorous with root-cause analysis.

The role requires strong bilingual English/Spanish communication and experience in pharmaceutical/biotechnological quality systems. Join a team focused on compliance and continuous improvement.

Qualifications

• Bachelor’s degree with strong foundation in natural sciences.
• Experience in quality/compliance management preferred.
• Knowledge of CAPA, Change Control, and Risk Management.
• Bilingual English/Spanish communication required.

Responsibilities

• Lead quality processes for nonconformance, CAPA, Change Control, and Risk Management.
• Monitor KPIs and ensure timely closure of actions across quality records and programs.
• Facilitate investigations and root-cause analysis to prevent regulatory liabilities.
• Prepare data for Annual Quality Reviews and related meetings.

Skills

Bilingual English/Spanish

Analytical skills

Interpersonal skills

Negotiation skills

Education

Bachelors in Natural Sciences

Job description

Associate Quality Analyst

Purpose

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 andtimely completion of actions and review of significant trends/issues to prevent regulatory liabilities andfinancial losses. Evaluate if actions were effective and verified after implementation. Confirm that actions donot adversely affect the finished product.
Maintain the required databases necessary for tracking and trending to ensure actions are implemented anddocumented.
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 appropriatelydocumented in a timely manner and that - when required - investigations are timely, rigorous and drive toroot cause to facilitate the identification and implementation of effective corrections, corrective andpreventive actions.
Provide in a timely manner information and analysis required for the Annual Quality Reviews, among othermeetings.
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.

Qualifications

Technical Skills

• Good verbal and written communication skills in both Spanish and English
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills

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 skillsin both languages, English and Spanish.
• Prior experience in CAPA, Change Control, and/or Risk Management is preferred.

**Weil Group is proud to be an Equal Employment Opportunity Employer.*