Associate Quality Analyst I

Artech-Information-Systems-L.l.c.; Barceloneta (PR); On-site; USD 28,000 - 33,000; Full time

Job summary

Artech-Information-Systems-L.l.c. is seeking an Associate Quality Analyst I for Barceloneta, PR to support CAPA, Change Control and Risk Management in a biologics/parenteral setting.

The role emphasizes quality and compliance, data tracking, and cross-functional collaboration across Spanish and English speakers. The position requires a Bachelor’s in Natural Sciences or related field, with experience in quality/compliance processes, CAPA, and Change Control.

Qualifications

• Must have strong verbal and written communication in English and Spanish
• Strong analytical and problem-solving abilities
• Effective interpersonal and negotiation skills
• Ability to work in a regulated quality environment

Responsibilities

• Monitor KPIs for CAPA, Change Control and Risk Management and drive timely actions
• Lead and review actions to ensure proper definition, timely completion and root-cause analysis
• Ensure actions do not adversely affect finished products
• Maintain databases for tracking and trending of actions
• Facilitate CAPA review boards and keep investigations timely, rigorous and effective
• Provide information and analyses for Annual Quality Reviews and other meetings
• Perform statistical analysis of exception documents and summarize with corrective actions

Job description

Title: Associate Quality Analyst I
Location: Barceloneta PR
Duration: 12+ Months
Pay Range: $20/hr. - $24/hr.

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, Client,
  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, 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.