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Integra LifeSciences QC Analyst II in Boston, Massachusetts

QC Analyst II

US–MA–Boston, Vacancy ID2021-38509

Career Home › Job Search Results ›QC Analyst II

Changing lives. Building careers.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”

RESPONSIBILITIES

Responsibilities

  • Perform chemical assay of solutions as well as general laboratory maintenance

  • Microbiological testing

  • Inspection and testing of raw materials, intermediates and final product

  • Environmental monitoring of clean rooms and water system

  • Develops and revises SOPs and trains appropriate employees

  • Maintains a working inventory of all components and archived materials and solutions

  • Writes and executes testing studies of finished products and components

  • Assist as needed in test method validation, implementation, and execution

  • Provides database support, generate reports and analyze process data

  • Assists Quality Assurance in document review and revision

  • Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs)

  • Investigates and reviews Nonconforming Material reports

  • Assist in preparing for and participating in FDA audits, customer audits, etc.

  • Demonstrate excellent organizational and time management skills

  • Perform other duties as required

QUALIFICATIONS

What are we looking for?

Qualifications

DESIRED MINIMUM QUALIFICATIONS

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

  • Bachelor’s Degree in the biological or chemical sciences or equivalent with related work experience is required.

  • A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated product preferred environment.

  • Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g. CQE, CQA, Six Sigma) preferred.

  • Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

  • Experience with performing Instron testing preferred. Working knowledge of standard laboratory practices and safety.

  • Ability to follow instructions precisely, recognize deviations, and recommend corrective action.

  • Exercises sound judgment and decision making when problem solving

  • Detail-oriented

  • Experience working in ISO Class 7 cleanrooms preferred

  • Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas – big and small – are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.

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 (https://www.eeoc.gov/laws/index.cfm) |EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm) 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.

Please see our Privacy Policy (https://www.integralife.com/privacy) . Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to our Terms of Use (https://www.integralife.com/terms) . You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Integra Life Sciences. Contact Us (https://www.integralife.com/contact) with any questions or search this site for more information.

© Copyright 2020 Integra LifeSciences Corporation. All Rights Reserved.

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