Associate Quality Analyst

Veg Group; Northern (KY); On-site; USD 45,000 - 62,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking an Associate Quality Analyst to support CAPA, Change Control and Risk Management within the pharmaceutical and biotechnology industries.

This role emphasizes quality compliance, data management, and rigorous documentation. The ideal candidate holds a natural sciences degree, appreciates regulatory standards, and can communicate effectively in English and Spanish.

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

Responsibilities

• Monitor performance through appropriate KPIs for CAPA, Change Control, and Risk Management.
• Provide leadership to ensure actions are properly reviewed and timely completed.
• Evaluate if actions were effective and verified after implementation.
• Maintain databases for tracking and trending of actions.
• Facilitate meetings to ensure timely identification and management of events.
• Drive documentation of non-conformances and investigations to root cause.
• Provide analysis required for Annual Quality Reviews and other meetings.
• Review and perform statistical analysis of exception documents and summarize corrective actions.

Skills

Quality management

CAPA

Change Control

Risk Management

Regulatory standards

English & Spanish communication

Computer literacy

Education

Bachelor’s degree in Natural Sciences

Job description

Current job opportunities are posted here as they become available.

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

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 skill in both languages, English and Spanish.
• 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-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.

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.