Document Control Administrator Jobs

Role Overview:

The Document Control Administrator is a quality focused individual responsible for the coordination, execution, and maintenance of the Document Control process according to approved procedures. The Document Control processes control the lifecycle of Quality Management System (QMS), Device Master Record (DMR) and Design History File (DHF) documentation. This position will interact with functions including, but not limited to; Quality Engineering, Software Quality Engineering, Sustaining Engineering, Regulatory Affairs, Software Engineering, Mechanical and Electrical Engineering, Manufacturing Engineering and the Project Management Organization.

Responsibilities:

• Leading or participating in process improvement projects
• Supports Quality Performance Metrics and Reporting
• Responsible for leading site and QMS training requirements
• Assesses and recommends operational efficiencies for the Corporate QARA Document Management Process.
• Records control, including maintaining oversight of off-site records storage and retrieval
• Collaborating with Information Technology (IT) for support of QMS processes and records
• Supports Quality Management Review
• Actively participates in internal audits, management review and other activities covered under Smith & Nephew Quality Manual and Policy, Policies and Procedures.
• Handle release and control of document updates. As well as recall/destruction of obsolete documents.
• Supports Corrective and Preventive Action
• Other duties as assigned
• Responsible for word processing and distribution of documents and maintenance of document files in a confidential and secure manner.
• Own the Corporate document control function through routing, review, distribution, approval, and release of documents.
• Supports Internal Quality Audits

Location: Andover, MA

Requirements:

• Demonstrated knowledge of GMP’s, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
• Experience working with Electronic Document Management Systems
• High School Diploma Required, Associates or Bachelors preferred.
• Must be skilled in the use of Microsoft Office Products including Word, Excel and PowerPoint, as well as MS Teams.
• Must have a minimum of one year in Document Management experience in a regulated industry - pharmaceutical or medical device--with direct document control experience.

Competencies:

• The ability to exhibit flexible thinking.
• Must be detail oriented and proficient at reviewing and editing documentation.
• The ability to effectively build and manage relationships within a highly matrix team in order to effectively negotiate and solve problems.
• Good written, verbal and presentation skills.
• The ability to maintain an attention to detail while completing multiple tasks.
• Must have effective planning and organizational skills, with the ability to prioritize, multitask and work with a high degree of accuracy and recall.
• The ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select efficient solutions and implement decisions.
• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
• A continuous improvement and quality mentality and a willingness to develop yourself and others.
• Must be able to work well under tight deadlines.
• Must have strong written, oral, interpersonal, group and telephone communication skills and the ability to collaborate cross functionally.

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.