Commercial Quality Staff Engineer

Johnson & Johnson Innovative Medicine • Shepherdsville, KY

6d • Onsite

About The Position

The Commercial Quality Staff Engineer is responsible for the oversight and execution of Quality Management Systems and compliance at the U.S. Pharma Distribution Centers. The Quality Engineer provides leadership and support of investigations, validations, quality system improvements, and audit readiness for the Distribution Center. Also monitors and reports on all quality system categories to assess compliance to GxP, regulatory, and standards. The Commercial Quality Staff Engineer serves as a single point of contact to the Commercial Quality Manager and Supply Chain partners on compliance related matters and is the liaison with multiple quality compliance organizations to drive timely resolution of quality and compliance related issues. Also, identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Engineer implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

Requirements

• A minimum of Bachelor’s Degree is preferred.
• A minimum of 6 years of experience in a highly regulated industry is required.
• Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.

Nice To Haves

• Quality and compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
• Experience with Warehouse Management Systems and SAP is preferred.
• Experience with Quality Event Management Systems such as Comet and/or EtQ is preferred.
• Proficiency in organizational and project management skills is preferred.
• Experience with Temperature Control is preferred.

Responsibilities

• Promote culture of continuous quality improvement and provide visibility to quality system performance through accurate metrics and reports.
• Supports the U.S. Pharma Customer Support Services Team with quality and compliance related matters and Delivery Service Issues (DSIs).
• Support internal and external quality system audits.
• Supports process qualification activities by developing and/or approving validation documentation.
• Leads quality and compliance projects as needed.
• Participates in developing and presenting departmental materials for Management review.
• Assists project teams with identification of quality system requirements to ensure compliance.
• Leads and supports Master Data, i.e., sIDMa, activities for the Distribution Center and provide quality support for the U.S. Pharma Distribution Centers.
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner.
• Identifies opportunities to continuously improve quality, cost, and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives.
• Identifies business issues, communicates to management, prioritizes for action, and leads improvement, and opportunities and problem solutions in collaboration with other Supply Chain partners.
• Responsible for monitoring of material destruction authorization (MDA) process.
• Responsible for audit inspection readiness activities and assisting in Health Authority and Regulatory Inspections including, but not limited to, TSA, DEA, FDA, and VAWD.
• Responsible for partnering with TS (Technology Services) on warehouse management system changes and testing activities.
• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems.
• Additionally, responsible for review and approval of records.
• Responsible for adherence to the Records Management and Retention processes.
• Responsible for adhering to the Training process.
• Responsible for supporting the Quality Agreement process.
• Responsible for supporting internal and external audits, including scheduling, planning, conducting, and follow-up activities.
• Responsible for providing quality and compliance oversight for execution of Protocols.
• Responsible for notifying/escalating critical quality issues to management in a timely manner.
• Responsible for providing data/information/metrics to management for Quality System Management Reviews.
• Responsible for development, review, and approval of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed.
• Responsible for performing gap assessments in local procedures to Johnson and Johnson Global Standards, Business processes, and External Standards and to remediate gaps.
• Responsible for the support of New Product Launch activities at the Distribution Center including Master Data (sIDMa) set-up.
• Responsible for ensuring Compliance and remaining current with local, state, federal, and international regulations and standards.
• Responsible for evaluating overall Compliance risk, recommending, implementing corrective actions, and tracking progress.
• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs.
• Responsible for supporting the 24/7 operations of the Distribution Center.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree