Senior Documentation Specialist

Location

Audubon, PA | United States

Job description

About Us :

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. 

Position Summary :

The primary function of the Senior Documentation Specialist will be to manage and organize all Quality Documentation that is required by Globus Medical and other regulatory agencies. This will include issuing, maintaining, controlling, and auditing documentation that is required for Quality and cGMP compliance.

Essential Functions :

• Coordinates, writes, and releases document change orders with inputs from other functional areas
• Communicates the impact of document change orders across functional areas
• Ensures documentation is complete, properly formatted and meets corporate standards
• Assists Director-QA in assigning and tracking new part and document numbers through the development cycle
• Assists in the creation of Customer private labeling materials and specifications (Labels, IFU, boxes, packaging specifications)
• Performs database searches, data analysis, and reports to assist in development activities
• Utilizes multiple manufacturing business systems, spreadsheets, graphs, word processors and product information management systems in order to facilitate the release, change, data storage & retrieval processes including the maintenance of a Document, Form & Regulations Reference Matrix
• Maintains the Employee Training System and related documentation
• Organizes and leads Quarterly plant wide documentation audit. Manages follow-up list from the audit
• Assists in conducting various training classes relating to documentation practices that pertain to Quality on an as needed basis
• Assists with the day-to-day functions of the Quality area
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties 

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.  

Qualifications :

• High School Diploma; Associate’s degree preferred
• 5 years GMP/FDA experience
• Strong interpersonal and communications skills; ability to develop and express ideas
• Responsiveness to changing business conditions and customer needs
• Ability to multi-task in a fast-paced environment
• Proficient organizational, typing and writing skills with an attention to detail
• Strong computer skills in Microsoft Office systems, scanning, archiving, and transmitting of electronic information
• Proven Auditing Skills 

Our Values :

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

• Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions
• Customer Focused : We listen to our customers’ needs and respond with a sense of urgency
• Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger
• Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. 

Physical Demands :

The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.

Equal Employment Opportunity :

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job tags

Salary