QA Engineer

100 % Onsite role Warren NJ
Work Schedule: Monday - Friday
Position Summary
The Senior Specialist is responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with Client policies, standards, procedures, and Global cGMP.
Functional responsibilities for the incumbent include facilitating Change Control Review Board (CCRB) and record tracking meetings (e.g. Change Actions weekly) as applicable, driving proactive and corrective improvements within Operations, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on time closure, evaluation of new requirements and emerging regulations, providing user support for the different Quality Systems as a site lead which includes integration activities and generation and review of Site Quality Metrics.
Duties/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.
ble to effectively multi-task.
Reporting Relationship
Reports to Senior Manager, QA Engineering
EDUCATION AND EXPERIENCE
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.
REQUIRED COMPETENCIES

1. Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
2. Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
3. 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.
4. Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function.
5. Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
6. 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.
7. Must possess an independent mindset and tenacity.
8. 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.
ble to recognize conflict and notify management with proposed recommendations for resolution.
ble to prepare written communications and communicate problems to management with clarity and accuracy.
ble to write and review reports with clarity and brevity.
ble 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.
bility to make independent and objective decisions and to work with minimal supervision.