Manager, Quality Assurance Shop Floor - Summit West NJ

Duties/Responsibilities

• Oversee performance of QA shop floor activities.
• Supervise Quality Assurance Shop Floor employees.
• Regularly spend time coaching and mentoring operators and QA personnel while on the manufacturing floor.
• Provide guidance and training on quality programs.
• Lead Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout operations/Label Operations.
• Proactively identify risks/critical issues and drive mitigations and escalate to management as needed.
• Develop, review and/or approve temporary and non-routine procedure for event response.
• Periodically observe operations.
• Proactively identify risks and drive improvements.
• Provide quality oversight to non-routine maintenance work.
• Review and approve return to service plans.
• Clock in and out for non-routine maintenance work.
• Coordinate and lead area walkthroughs to identify quality issues.
• Negotiate remediations and drive alignment of implementation plans.
• Act as a QA subject matter expert on behalf of the facility during audits and inspections.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform review of operational documentation including manufacturing batch records.

Qualifications

• Specific Knowledge, Skills, Abilities:
• Previous Supervisory/Managerial Experience is preferred.
• Action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
• Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
• Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Requires little direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Able to provide directions to others within the team.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

• Specific Knowledge, Skills, Abilities:
• Previous Supervisory/Managerial Experience is preferred.
• Action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
• Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
• Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Requires little direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Able to provide directions to others within the team.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.