Sr. Document Control Specialist (Information Technology)

About the Family: We have been family-owned since 1908 and treat customers, patients, and employees like family. It drives our unique connection with health care professionals, and it's what makes their success our success. For us it's personal listening, advising, supporting, and celebrating them as we pursue a shared vision to help the world look better, feel better and live better.

We are a leading, global aesthetics business, and our award-winning portfolio of injectables, devices and skin care products help health care professionals fuel confidence through aesthetic medicine.

Key Responsibilities

Team Lead

• Helps direct daily workload of the Document Control Team.
• Lead by example and ensure Merz Norms and Value are followed.

Quality Management System Document Support

• Manage the processing of all document types, including Document Change Notices, Marketing Materials, Mfg Support documents, Facilities Maintenance documents, Change Requests, Protocols and Reports, etc. through the collaboration / review process, uploading attachments if needed, and ensuring final document meets standards for Document Control before release.
• Responsible for communicating document translations to the approved translation vendor(s) and ensuring they are appropriately released into the eQMS for applicable document revisions.
• Manages Document Control inbox by resolving customer requests or delegating the requests to the appropriate Document Control personnel.
• Generating new InfoCards in the eQMS for Labels, Templates, MIs, TIs, Preproduction Documents and Protocols and Reports upon request.
• Ordering supplies utilized by Document Control, specifically record retention boxes, folders, etc.

Standards

• Maintain awareness of changes to global regulatory requirements and relevant standards related to Merz and support the appropriate requirement or standard owner to ensure effective implementation.
• Ensure the most current industry standards and federal regulations are available for use by ordering standards and uploading them into a company data base for storage and easy access.
• Managing personnel in vendor website, adding or removing.

Writing/Revising Procedures

• Generating and/or revising Quality System Management procedures.

Scanning

• Scanning documents to be uploaded as attachments into the eQMS; scanning various document groups into company database for electronic storage and retrieval, training personnel from other departments on scanning.

Document Storage and Prep

• Manages the dissemination and retrieval of procedures and records throughout the organization for record retention purposes. This includes contacting the offsite storage location to coordinate storage/retrieval of records, scanning, logging and boxing documents for off-site.
• File Quality Management System documents and records for hardcopy storage.

Proofreader

• Proofread various documents to verify accuracy.

Training for eQMS

• Perform eQMS training for individuals that require access to Document Control Processes and workflows, specifically DCNs and Protocol and Reports.

Other Duties as Assigned 

•  Provides support to Quality Management personnel and performs other duties as assigned.

Education:

• High School Diploma or Equivalent Required
• Associate's Degree Preferred

Experience:

• High School Diploma with Minium of 5 Years Document Control and/or Related Experience -or-
• Associate's Degree with 3 Years of Experience Document Control and/or Related Experience -or-
• Bachelor's Degree with 1 Year of Experience Document Control and/or Related Experience

Knowledge Skills and Abilities: 

• Operate Personal Computer, copying machines, printers and scanners.
• Leadership skills.
• Thorough understanding and knowledge of documentation, records management, and change control for Quality System requirements in support of GxP regulations.
• Ability to work independently.
• Ability to collaborate effectively with various departments.

Benefits:

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

 

Your benefits and PTO start the date you're hired with no waiting period!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Documentation Life Cycle