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The Specialist I, Document Control & Training manages the Document Control & Training Management processes and maintains associated procedures in accordance with FDA 21 CFR Part 820, ISO 13485, state and local regulations, and Integra policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Acts in the capacity of Agile Analyst

• Manages Change Control ECR/ ECO processes

• Manages the Document Control, DCO process.

• Owns the Deviation process. Reviews Deviations prior to their approval, releases Deviation as effective and closes Deviations in coordination with the Deviation owners.

• Is a point of contact with MasterControl

• Communicate with MasterControl support for technical issues.

• Enter maintain, and archive users in the MasterControl system and provide support as needed.

• Acts as administrator for Training and Competency program

• Organize, Implement, and update training competency program and Training Job codes.

• Maintain employee training records (hard or electronic) and ensure that training files are current.

• Based on the Work Orders printed and provided by the Manufacturing:

• Prints corresponding Job Travelers from Agile.

• Prints corresponding IFUs from Agile or gets preprinted IFUs.

• Applies Master Stamp on printed Job Travelers and IFUs and makes them available to manufacturing.

• Writes and reviews QMS SOPs as necessary.

• Administers elements of the site quality system in relationship to the corporate quality system and makes revisions as needed.

• Conducts trend analysis of QA activities and other quality indicators as needed.

• Ensures all document control quality records are appropriately filed and easily retrievable in the quality department, and/ or Agile/ Master Control software.

• Performs other related duties as assigned.

REQUIRED SKILLS & KNOWLEDGE

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

Education & Experience:

• Bachelor’s degree or equivalent in a related scientific discipline with 0 - 2 year of experience; or

• Associate degree, or equivalent in a related scientific discipline with 3 - 5 years of experience; or

• High School degree or equivalent with a minimum of 5 years of experience

• Team-focused attitude.

• Experience with Electronic Document Management System (EDMS) highly preferred.

• Demonstrated knowledge of cGMP, ISO 13485, and other national and international regulations and standards.

• Strong communication skills, both written and verbal.

• Self-motivator with an analytic nature. Strong organizational, communication, and interpersonal skills.

• Well informed and proficient in the use of modern technology, especially electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications. Experience in Agile and Oracle systems is a plus.

• Ability to obtain Quality training and/or certifications as needed.

• Organized, attention to detail and excellent analytical skills.

• Excellent communication skills, both written and verbal.

• Excellent organization, prioritization and problem-solving skills

• Able to lift 40 lbs.

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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