Associate Quality Analyst

Pinnaql • Guaynabo, PR

10d

About The Position

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Associate Quality Analyst.

Requirements

• 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 skill in both languages, English and Spanish.

Nice To Haves

• Prior experience in CAPA, Change Control, and/or Risk Management is preferred.

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-insinspections, 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.

Benefits

• At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level