Daily Work Schedule Expectations

ALL candidates must be available for any shift/weekend/holidays.

Associate Rotating shift – 4 days at 10hours

2 months rotation on each shift 1st, 2nd, 3rd shift

Area worked based in manufacturing schedule of 24/7

Is overtime offered or required?

Must be available to work OT based in business needs

Associate Quality Analyst

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, 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

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.