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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. 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 position, the employee must repeatedly sit, listen, speak and can move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Ability to travel via car, train and/or airplane to domestic and international locations as needed.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.  The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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