Job Information
Integra LifeSciences Document Control Coordinator - 2nd Shift in Plainsboro, New Jersey
Changing lives. Building Careers.
Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
RESPONSIBILITIES
Responsible for supporting the maintenance of the document control system during 2nd shift
Responsible for formatting, proper spelling and clarity of text for any written documents submitted todocument control.
Review all electronic documents submitted to document control for correct formatting, spelling and clarity oftext before releasing as approved documents.
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, 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 record and validations
QUALIFICATIONS
Minimum high school diploma
Minimum of 1-2 years' experience in document and promotional materials management using electronicdocument management systems or with manual systems using electronic document storage.
Minimum of 1-2 years' experience in a Quality Systems I Regulatory Compliance environment with aworking knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiaritywith 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.
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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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 careers@integralife.com or call us at 855-936-2666.
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