Changing lives. Building careers.

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 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.