Document Control Specialist

GENERAL DESCRIPTION

Assistant to the Document Control Coordinator in the maintenance and control of all documents at Command Medical Products, Inc. with considerable accuracy in all areas. Under the direction of the

ESSENTIAL FUNCTIONS

Process Label Requests from Production, ensuring labels are clear, accurate and correct quantities

Assist the activities of Document Control, including distribution and auditing controlled documents, maintenance of electronic department directories, tracking and reporting on document review progress

Works under the direction of the Document Control Coordinator

Manages archival activities for controlled documents and validation files

Reviews and proofreads documents for consistency of document format and system concerns

Verifies and issues production documents

Uses department systems to track and manage and control issued documents.

Effectively follows SOPs, policies, and cGMPs.

Follows Command Medical Products, Inc. policies and procedures related to document control

Ability to fill-in for the Document Control Coordinator performing daily essential duties

Performs other tasks or duties as directed by the Document Control Coordinator and Manager of Quality Assurance and Regulatory Affairs

MINIMUM QUALIFICATIONS

Strong communication, prioritization, and organizational skills

Good writing and proofing skills

Works under minimal supervision

Good problem solving and organizational ability

Strong interpersonal skills and ability to work with others in a positive and collaborative manner

Demonstrated ability to work accurately, follow instructions, schedules, and timelines

Experience with MS Word, Excel, Access, as well as Adobe Acrobat, etc.

Well-organized, and eager to learn and be challenged.

Flexible and able to adapt to change in priorities as needed

REQUIRED EDUCATION AND EXPERIENCE

High School Diploma

Good to excellent computer skills.

PREFERRED

Experience with Quality System Documentation and good documentation practices

Document Control or other Quality Assurance-related experience in a cGMP environment is a plus.

Knowledge of ISO, FDA and cGMP concepts and guidelines.

Prior experience in medical device or other GMP-regulated industry is preferred