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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. 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 in Boston, MA.

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 interpretate 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.

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, or 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%.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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