QA Engineering Specialist - Katalyst Healthcares & Life Sciences
Warren, NJ 07059
About the Job
Responsibilities:
- Ensure control of systems, processes and products through facilitation of CCRB.
- Represent site and provide impact assessment for global changes at Global CCRB
- Monitor and track external audit/inspection commitments to ensure timely closure.
- Track site change controls and ensure appropriate requirements are identified and completed for implementation.
- Provide weekly change control due date updates to the Tier board metrices.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Familiar with Veeva Vault QMS system.
- Able to effectively multi-task.
- Reporting Relationship
- Reports to Senior Manager, QA Engineering
- B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.
- Experience with cGMP manufacturing, Quality, and compliance.
- Excellent verbal and written communication skills.
- Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.
- Experience with cGMP manufacturing, Quality, and compliance.
- Excellent verbal and written communication skills.
- Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
- Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across most of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Must possess an independent mindset and tenacity.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Work is self-directed.
- Confident in making decisions for minor issues.
- Routinely recognizes Quality issues and solves problems.
- Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Is recognized Subject Matter Expert within the group.
- Provides guidance to other employees in interpretation of complex data.
- Capable of providing input within the department and cross functional teams.
- Build relationships internally within and with cross functional teams.
- Contributes to goals within the work group.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to write and review reports with clarity and brevity.
- Able to effectively multi-task and execute project management skills.
- Knowledge of US and global cGMP requirements.
- Understanding of aseptic manufacturing processes.
- Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
- Ability to make independent and objective decisions and to work with minimal supervision.
Source : Katalyst Healthcares & Life Sciences