Location: Barceloneta, PR Shifts: Must have full availability to work rotating shifts based on business needs. Work schedules are subject to change and may include, but are not limited to, the following shifts (including weekends/holidays):
1st shift: 6:00am - 2:00pm
2nd shift: 2:00pm - 10:00pm
3rd shift: 10:00pm - 6:00am
4 days at 10 hours
2 months rotation on each shift 1st, 2nd, 3rd shift
Area worked based in manufacturing schedule of 24/7
Purpose:
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.
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.
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.
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $24.44/hr.
