Document Control Specialist 2
At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Document Control Specialist 2 role is responsible for managing and maintaining the company's documents, ensuring they are organized, secure, up-to-date, and accessible while complying with company standards.
This role is accountable for implementing document control procedures, managing all document lifecycle through the Electronic Document Management System, and performing data entry and filing, ensuring document retention policies are met.
This role is also accountable for maintaining the site training requirements in support of manufacturing and site needs.
What will you be doing?
- Issuance of Batch Records, labels, logbooks, and forms for commercial product manufacturing as required, ensuring they are properly issued and on a timely basis.
- Provide support for document control function through routing, review, distribution, approval, and release of documents. Maintain the flow of controlled documents through the eDMS and electronic Learning Management System.
- Process Standard Operating Procedures, Batch Records, Validation Documentation, misc. reports, Forms and Material Specifications through the applicable eDMS program in a compliant manner.
- Create, implement, and deliver training programs for varying levels of individuals within the eDMS system. Manage and track qualified training requirements in support of manufacturing and site needs. Maintain updated and efficient curriculum database and training records. Monitor / report training compliance and effectiveness to management.
- Provide support for internal audits and external regulatory inspections among other duties as required within the role.
What will you need to be successful?
Required High School or GED.Preferred Associates Degree in Business, Life Sciences or related field.Minimum of 3 years of document management and training related experience in a regulated industry; Pharmaceutical or medical device experience with direct document control experience preferred.Must have effective planning and organizational skills, with the ability to prioritize, multitask and work with a high degree of accuracy and recall.Must have strong written, oral, interpersonal, and group communication skills.Must be skilled in the use of Microsoft Office products including Microsoft Access, Word, and PowerPoint.Moderate to advanced skills in Excel preferred.High attention to detail and strong customer service skills required.This position requires full-time on-site work at our Fort Worth - Vickery office.Physical Demands : While performing the duties of this position, the Employee will be required to walk, stand, lift (up to 20 lbs), climb ladders / stairs, and work under tight schedules.
Travel Requirements : Up to 10% (domestic).
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging : Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging.Your Future : 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition ReimbursementWork / Life Balance : Flexible Personal / Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service DayYour Wellbeing : Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance ProgramTraining : Hands-On, Team-Customized, MentorshipExtra Perks : Discounts on fitness clubs, travel and more!Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.