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The Compliance Specialist – Document and Change Control plays a key role in the success of site Quality Management and compliance activities. The Compliance Specialist – Document and Change Control is responsible for working closely with all departments to help assure that Standard Operating Procedures, Work Instructions, Change Control, etc. are performed in a timely manner and in compliance with the Quality Management standard operating procedures. The Compliance Specialist – Document and Change Control updates the procedures and the validations activities by working closely with the Quality Engineer who initiates and manages the Quality Management system improvements. The Compliance Specialist – Document and Change Control plays a key role in the execution of the organization’s Quality Management System and assists in continuous improvement of the Quality Management System. The position will ensure compliance with applicable FDA, AATB, ISO, State regulations/requirements and Integra LifeSciences standard operating procedures.

RESPONSIBILITIES

• Exercises discretion and judgement on how we assess, control and release our Quality changes.

• Develop change management plans for projects and/or change initiatives.

• Identify risks and develop risk mitigation tactics.

• Identify and manage anticipated resistance to change.

• Prioritize change requests, assessing their impact, and accepting or rejecting changes.

• Develop communication strategies, activities, and content.

• Administrative duties include but are not limited to the monitoring of information relative to process improvements, audit findings, definition of SOPs updates, definition and maintenance of the site validation plan, validation assessments, validation plans, qualification protocols, qualification reports, and qualification archive management.

• Assist in the development of an Administrative Hierarchy SOP defining the model, training, and migration of existing SOPs into an Administrative Hierarchy model.

• Drive project management activities such as development of plan, coordinating activities with project resources, facilitating regular reoccurring meetings with team to effectively drive projects to completion per timeline and budget.

• Interface with various departments, corporate functions, and external suppliers to define new processes and effectively develop new SOPs and exercise independent judgement.

• Participate in the definition and implementation of Quality Management System process improvements including the implementation of software solutions.

• Serve as meeting coordinator on Quality Management activities such as new processes, revisions to existing processes, change order management, validations, etc. and is able to identify omissions in providing the context for discussion and decisions.

• Monitor the effectiveness of the Quality Management System.

• Trend Quality Management System metrics and present defined reports at specified intervals such as the number of SOPs revised, number of Change Orders, etc.

• Participate and coordinate activities for external party audits.

• Support process qualification processes.

• Assess, control and release changes to site Quality Management procedures for the Memphis site.

• Facilitate Good Documentation Practices.

• Train and educate new/existing personnel on site quality system requirements and external regulatory standards.

• Facilitate review meetings with Quality team on site SOP creation and revision.

• Conduct regular assessments to determine whether policies are compliant with the law and company policies.

• Uphold regulatory guidelines set forth by the FDA, AATB, HHS, and OSHA.

• Other duties as assigned by supervisor or manager.

REQUIRED SKILLS & KNOWLEDGE

• Bachelor’s degree, specialization in science, engineering, or related technical field required with minimum 3 years of experience working within an FDA regulated industry (e.g., Medical Device, Pharmaceutical, HCT/P).

• Understanding of 21 CFR 820 and/or 1271, ISO 13485, AATB Standards, and ISO 14971 preferred.

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

• Must have experience working in MS Office Software Suite, and ERP/MRP management software experience is a plus.

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

• Organized, attention to detail and maintain appropriate 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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