Documentation Specialist

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Summary Description:

This position supports the documentation needs for expanding our Advanced Technology/Engineering Technology (AT/ET) process. Responsibilities include coordinating with various departments and managing the creation, revision, and maintenance of all project documentation. The role ensures accurate and compliant paperwork, facilitating smooth project execution.

Supervision Received:

Directly reports to the Sr. Manager, Technology Transfer Engineering

Supervision Exercised:

This position does not directly supervise employees but will coordinate closely with various departments.

Essential Duties and Responsibilities:

Coordinate with Product Development, Process Engineering, local Plant Engineering, Quality, Validation, Regulatory, Manufacturing, and other relevant groups to collect, review, and manage project documentation for successful project execution.

Support all documentation activities related to project management, process development, improvement, IQ/OQ/PQ validations, and manufacturing processes.

Create, revise, and maintain accurate and compliant project documentation, ensuring alignment with Integras internal standards and external regulations.

Monitor and track the documentation workflow to ensure timely updates and distribution of documentation to relevant stakeholders for smooth project execution.

Conduct regularly scheduled update meetings with stakeholders.

Assist in the development and implementation of documentation control processes and procedures.

Ensure proper archiving and easy retrieval of all documentation for audits and future reference.

Provide training and support to team members on documentation requirements and procedures.

Collaborate closely with compliance and quality assurance teams to ensure that all documentation meets regulatory standards.

Desired Minimum Qualifications:

BS in Mechanical, Chemical, Electrical Engineering, or equivalent combination of education and experience. Scientific degrees will be considered appropriate work experience.

One to five years of experience in a medical device or regulated industry.

Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements related to documentation in the medical device industry.

Proficiency in document control systems, Microsoft office and software, with the ability to effectively manage and organize large volumes of documentation.

Strong communication and interpersonal skills, with the ability to coordinate with various departments and stakeholders effectively.

Experience with quality system regulation, design control and process validation, engineering change controls, and regulatory procedures a plus.

Tools and Equipment Used:

Microsoft Office software and tools (Outlook, Project, PowerPoint, Word), Adobe Acrobat.

Physical Requirements:

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, and speak.

Adverse Working Conditions:

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

Travel:

No travel is required for this position.

Selection Guidelines:

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

Disclaimer:

The duties listed above are intended only as illustrations of the various types of work that may be

performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

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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