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ESSENTIAL DUTIES AND RESPONSIBILITIES:

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

• Responsible for supervising all Microbiology Laboratory personnel and operations, including product testing, environmental monitoring of cleanrooms, cleanroom gowning qualifications, utility testing (WFI, pure steam, clean compressed air), lab supply purchasing, and laboratory projects.

• Responsible for reviewing and approving laboratory work.

• Assigns duties and responsibilities to subordinate laboratory analysts, including benchwork, laboratory maintenance activities, laboratory projects, data review, and data entry.

• Coordinates production activities with Operations teams and schedules Microbiologists to support these activities across shifts.

• Manages cleanroom gowning qualification for all plant personnel. Coordinates with other departments to schedule personnel for qualification.

• Coordinates microbiological testing performed at external laboratories including sending samples and documenting test requirements per procedure. Interacts with suppliers and customers as needed.

• Maintains GMP/GLP laboratory logbooks and documentation relevant to the duties and responsibilities assigned.

• Collaborates on the development of laboratory test methods and oversees execution of test method validations and implementation. Provides support as needed for other validations that involve microbiological testing, including EMPQs and utility qualifications.

• Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits.

• Performs and supports Out of Specification (OOS) investigations, Non-Conformance (NC) investigations, and Corrective Action / Preventative Actions (CAPA).

• Prepares and/or reviews trending reports for quality control testing, environmental monitoring, and other laboratory testing as required.

• Provides staff with leadership, support, and mentoring. Conducts performance reviews for lab personnel, holds regular team meetings, and provides training to junior staff as needed.​

DESIRED MINIMUM QUALIFICATIONS:

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

•Bachelor’s degree or higher in Microbiology, Biology, or related field.

•7+ years of relevant GMP/GLP laboratory experience in regulated industry, with supervisory and project leadership experience.

•Must have method development, validation, and transfer experience in the pharma or medical device industry.

•Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings.

•Knowledge of MS Office Suite.

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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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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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