Quality Laboratory Lead

Mentor Texas LP., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Laboratory Lead! The location for this position is in Irving, TX!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Quality Laboratory Lead has the objective of maintaining high quality standards of the product manufacturing process and compliance with regulatory requirements, administers Quality Control laboratory support to the Quality Operations, and directly supervises Laboratory Sr Supervisors in day to day activities supporting Manufacturing by providing adequate laboratory support, test result reporting, test method validation, documentation review and support projects, process and new product introductions or upgrading of existing processes and products and subsequent qualifications. The role has a solid reporting line into the Site Quality Lead to ensure alignment with QA.

Key Responsibilities:

• Leading, budgeting and resourcing a microbiology, analytical, incoming goods laboratory group. Directs and administers the activities of Lab (Sr) supervisors, Lab Engineers and Lab (Services) technicians.
• Carries out leading responsibilities in accordance with the organization’s policies and applicable laws including regarding health and safety.
• Evaluates and recommends staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
• Evaluates, recommends and approves expenses requirements to ensure maximum utilization of laboratory supplies to fulfill department objectives.
• Approves purchases and expense reports submitted by direct reports.
• Ensures that the quality and testing aspects for new processes, products and or upgrading of existing processes and products and subsequent PQ’s and PPQ’s are met.
• Ensures that the testing at external supplier aspects for base business continuation, new processes, products and or upgrading of existing processes and products and subsequent PQ’s and PPQ’s are met.
• Supports/Initiates investigations for non-conformances and OOS.
• Supports Operations in evaluation and implementation of actions plans to eliminate root causes of non-conformances.
• Ensures incoming goods receipt, sampling and testing is performed supporting Operations Base Business Execution.
• Ensures analytical, in process and finished device testing is performed supporting Operations Base Business Execution.
• Ensures environmental and microbiology testing is performed supporting Operations Base Business Execution.
• Ensures the coordination of test method, laboratory equipment validation (IQ/OQ/PQ) and acts as validation approver for Operations Validations.
• Supports internal audit programs
• Initiating and implementation of corrective and preventive action and quality data trending for CAPA review board evaluation.
• SME during projects, regulatory, MDD and notified body audits/inspections.
• Initiating and approval of labs and supplier quality related Non-Conformances.
• Promotes the use of Process Excellence tools to improve analytical thinking and problem-solving techniques.
• Provides testing support to plant wide initiatives such as implementation of new initiatives safety, environmental and Quality related initiatives.
• Supports ongoing continuing efforts and projects to improve our manufacturing Quality Systems, processes.
• Supports and promotes cost savings opportunities that work toward global objectives in the organization.
• Fosters teamwork and supports total associate involvement.
• Reports accidents, incidents, near misses, and hazardous situations in a timely manner and participates in the corrective action process.
• Ensures compliance with company policies and procedures including safety.
• Actively supports other plant functions in the implementation of company programs and projects.
• Ensures laboratory test equipment is in a compliant state, including timely replacement and new equipment introduction
• Facilitate the execution & performance of the Records Management Program as per PL553-005 & related RM documentation at Mentor Leiden.
• Ensures accurate Returned Goods evaluation
• Owner of the contents of the Quarantine Area.
• Ensures LIMS test logging is enabled, accurately executed and the system is updated properly as part of change management.
• Ensure compliance with applicable laboratory regulations, standards and procedures