Document Control Specialist 1

Life Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Document Control Specialist 1 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 lifecycles through the Electronic Document Management System, and performing data entry and filing, ensuring document retention policies are met.

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.
• 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 1 year experience with document management in a regulated industry, Pharmaceutical or medical device experience with direct document control 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.

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).

You Unlimited.
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, Learn more about Employee Inclusion Groups on our website ).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra 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.

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You. Unlimited.
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