Specialist, Quality Documentation

Integra LifeSciences • Princeton, FL

21h

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation, preferred.
• Proficiency in training management and product lifecycle management (Agile) systems preferred

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document change management system, including change processing, organization of master documents, and archival of historical documents.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.

Benefits

• 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/

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees