Specialist, Quality Documentation

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.

Responsibilities

• Operate in Integra’s corporate document control and training systems to transact changes to quality system documents.
• Support quality system training and management of quality system training requirements in LMS
• Support record retention program (archiving for offsite, electronic signature)
• Execute change orders in alignment with quality system priorities and the global priorities as defined in the CMP and risk prioritization projects
• Support metric and Management Review updates by managing and collecting periodic review data
• Assist in the administration of the corporate document change management system, including change processing, organization of master documents, and archival of historical documents. Review and manage change records to ensure the information is accurate and complete, including implementation strategies to fulfill training requirements.
• Participate in the development and roll-out of document change management tools.
• Promote and provide guidance in Good Documentation Practices.
• Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
• Support Record Management, Retention and Repository activities and processes.
  
  

Qualifications

• A minimum of a Bachelor's Degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline
• A minimum of 3-5 years of overall experience in the medical device/pharmaceutical industry.
• Demonstrated knowledge of QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards is required.
• Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation, preferred.
• Strong oral and written communication skills and effective interpersonal skills.
• Ability to multitask, prioritize and meet deadlines.
• Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.
• Proficiency in training management and product lifecycle management (Agile) systems preferred
  
  

Salary Pay Range:

$71,300.00 - $97,750.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

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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