"Alerted.org

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

+ Responsible for supporting the maintenance of the document control system during 1st shift.

+ Day-to-day management of resources, planning to meet goals and deadlines

+ This role ensures compliance within the document management system, document storage, retention, and document reconciliation

+ Serve as a document control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures as needed

+ Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional departments

+ Support Document management system users with workflow handling and electronic system usage as needed

+ Manage the periodic review process for procedures as needed

+ May identify and implement process-level efficiencies

+ Drive continuous improvement

+ Maintains all ISO/FDA standard operating procedures, work instructions, and forms.

+ Maintains revision and approval status of all documents.

+ Maintains hard copies of all approved documentation.

+ Maintains appropriate templates for access.

+ Tracking, follow-up, and implementation of, including but not limited to, ECRs, DCRs, ECOs, DCOs, and MCOs. deviations, validation records, batch records, and notebooks.

+ Responsible for processing change orders through the Agile PLM system.

+ Support internal audits when needed

+ Supports external audits when needed

+ Issues controlled documentation such as batch records and validations

+ Have advanced computer skills to increase department productivity, as well as broadening technical and scientific knowledge

QUALIFICATIONS

+ Bachelor's degree or equivalent with 5+ years of experience,

+ Minimum of 2 years' experience in document and promotional materials management using electronic document management systems or manual systems using electronic document storage.

+ Minimum of 1-2 years' experience in a Quality Systems I Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.

+ Capable of both written and verbal effective communication skills.

+ Proficient in the Microsoft Office suite of products.

+ Proficient in Oracle R12/Agile 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 (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm)

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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)