Quality Assurance (QA) Specialist II

Title: Associate Quality Analyst
Location: Barceloneta PR
Duration: 12+ Months
Pay Range: $25/hr - $23/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 :
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
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 :
List required and preferred qualifications up to 10). Include education, skills and experience.
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.

Experience Level = 1-3 Years