Integra LifeSciences
Document Control Specialist - 2nd Shift
Integra LifeSciences, Plainsboro, New Jersey, us, 08536
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
.
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
Seve 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 electronicdocument management systems or 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.
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/laws/index.cfm) | 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 careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
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
.
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
Seve 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 electronicdocument management systems or 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.
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/laws/index.cfm) | 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 careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)