Associate Quality Analyst I

Validation-; Barceloneta (PR); Vor Ort; USD 60.000 - 90.000; Vollzeit

Zusammenfassung

Validation & Engineering Group, Inc. seeks an Associate Quality Analyst I to drive quality processes, CAPA, change control, and risk management in a regulated setting. The role emphasizes leadership in nonconformance handling and data-driven improvement.

The candidate will monitor KPIs, maintain tracking databases, and support annual quality reviews. English and Spanish communication, plus strong technical writing and regulatory knowledge, are required.

Qualifikationen

• Bachelor’s degree in Natural Sciences, preferrably 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.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• 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.
• Technical Writing skills and investigations processes.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Available to work extended hours, possibility of weekends and holidays.

Aufgaben

• Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management.
• Monitor performance through appropriate KPIs for CAPA, Change Control, and Risk Management. Ensure timely completion of actions in quality records and programs.
• Provide leadership to ensure actions are properly reviewed and completed, and review significant trends/issues to prevent regulatory liabilities.
• Maintain databases for tracking and trending to ensure actions are implemented and documented.
• Facilitate meetings to ensure timely identification and management of events, including CAPA review board and investigations.
• Provide information and analysis for the Annual Quality Reviews and other meetings.
• Review and perform statistical analysis of exception documents by reasons and identify trends for remediation.

Kenntnisse

Quality management

Analytical skills

Technical writing

Bilingual English/Spanish

Ausbildung

Bachelor’s degree in Natural Sciences (Biology or Chemistry)

Tools

MS Windows

Microsoft Office

Jobbeschreibung

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 I

Description:

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.

Qualifications:

• Bachelor’s degree in Natural Sciences, preferrably 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.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• 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.
• Technical Writing skills and investigations processes.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Available to work extended hours, possibility of weekends and holidays.

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.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.