Location: Buena, NJ
The Quality Continuous Improvement Manager will be responsible for optimizing all laboratory processes, procedures, and tools in order to ensure effective and efficient delivery of laboratory services to both internal and external customers. This individual will be responsible for solving problems, reducing the number of laboratory deviations, and optimizing efficiencies through various continuous improvement and change management techniques. In addition, this individual will be pivotal in driving proactive improvements into our Quality Systems as part of our continuous process improvement efforts while ensuring that we remain compliant and in a state of permanent inspection readiness.
Reporting Relationships: One direct report
- Leads efforts to implement Process Control and Management (process definition, documentation, ownership, metrics, and monitoring systems)
- Works with local team members to instill effective daily work management behaviors
- Leads efforts to implement process control enhancements, documentation, ownership, metrics, and monitoring systems
- Responsible for driving enhancements into our LIMS system by interacting with the vendor and managing the punch list
- Actively communicates with project sponsors and stake holders
- Prepared to roll up their sleeves and work through detailed issues
- Drive improvements into all Quality systems as they relate to the laboratory in order to ensure 100% compliance and permanent inspection readiness
- Participate in investigations impacting the laboratory in order to ensure that the true root cause has been identified and that the CAPA effectively remediates the issue
- Develop proactive strategies that will continually move us to operational excellence
- Redesign, enhance, and optimize processes with patient safety in mind
- Organizing, managing, developing and implementing project plans, processes, and systems to ensure timely project completion, in compliance with regulatory agency requirement
- Participates, present and provide rationale for the Quality Control laboratory during periodic audits and regulatory inspection and customer visits/conference calls as required.
- Drive implementation of continuous improvement, operational excellence projects while staying within budget
- Other duties as assigned by management
- Education: Bachelor’s degree in Chemistry, Engineering or other Physical Sciences
- Minimum 8 – 10 years of experience in medical device and/or pharmaceutical QA or QC role
- Working knowledge in the quality systems for the medical device and/or pharmaceutical industry
- Working knowledge in FDA 21 CFR Parts 11, 210, 211 and 820 and ICH quality system requirements
- Ability to work collaboratively in a professional and effective manner across all Teligent departments
- Strong project management skills and problem-solving skills
- Working knowledge of risk management
- Strong leadership skills:
- Ability to delegate and verify
- Ability to manage and prioritize multiple tasks
- Ability to guide and motivate personnel
- Ability to plan and organize available resources and activities in-order to reach predefined goals
- Awareness of inter-personnel relationships in the company
- Experience in using computer programs (MS Word, Excel, and Access)
- Strong verbal and written communication skills
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.