Sr. Laboratory Process Improvement Specialist

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Senior Laboratory Process Improvement Specialist will partner with Integra’s internal operational laboratories to implement programs to improve their quality, reliability, and throughput. Under direct supervision of Program Director – Laboratory Services, this individual will have a dotted line reporting structure to the local site laboratory leader. The Sr. Lab Specialist will be responsible for implementing continuous improvement programs, identifying and tracking quality and operational key performance indicators, implementing compliance programs, and partnering with other Integra laboratories to execute harmonization projects at their local site. An understanding of laboratory operations/GLP/ISO 17025 is required. The position reports into Global Laboratories, Microbiology and Sterility Assurance (GLMS) but will be located on-site at our Plainsboro, NJ manufacturing facility.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Responsible for implementation of global procedures and systems at local on-site laboratories

• Create and revise procedures for laboratory operations, including harmonization/standardization of existing procedures to global processes.

• Collaborate with cross-functional team to support and optimize ongoing laboratory initiatives.

• Identify, track, and interpret relevant key performance indicators to monitor quality compliance risk and operational excellence within local laboratories.

• Implement laboratory continuous improvement program, including identification of new opportunities, scoping, and execution.

• Identify and facilitate technical talent training, mentorship or development programs for laboratory staff.

• Drive quality culture improvements within the laboratory.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Minimum required education and experience: Bachelor’s degree is required, preferably Master of Science degree, in Engineering, Science or similar discipline. Bachelor degree or equivalent with 5+ years of experience, Master degree with 3+ years of experience, Doctoral degree with 0-2 years of experience

• 4+ years of experience in a laboratory or manufacturing engineering in a medical device or pharmaceutical environment.

• Creative thinking and proactive problem-solving skills.

• Lean Six Sigma training/knowledge preferred.

• Demonstrates excellent organizational and verbal and written communication skills.

• Results oriented with a strong focus on quality principles.

• Excellent technical writing skills with an understanding of good documentation practice.

• Experience with test method validations and managing projects independently.

• Experience implementing continuous improvement programs in a laboratory or manufacturing environment

• Working knowledge of Good Laboratory Practices (GLP)

• Experience with implementing LIMS software preferred

• Experience with PowerBI, Visio, AgilePLM

• Working knowledge of applicable standards including, but not limited to: ISO 17025, ISO 13485

• Ability to track milestones and manage projects.

• Working knowledge of applicable regulations and their interpretation within industry.

• Ability to travel up to 5-10%.

TOOLS AND EQUIPMENT USED

General office equipment: computers, printers, copiers, telephone communications equipment.

Laboratory testing suppliers and equipment.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the po