Doc Control Specialist II

Location
United States
Posted
Jan 29, 2021
Ref
452396
Required Education
High School or equivalent
Position Type
Full time
PURPOSE OF JOB : Maintain compliance in the areas of document control and supplier control for the company and clients in support of the company's strategic plan.

MAJOR DUTIES AND RESPONSIBILITIES :
  • Act as Document Control to process all documents through both internal and external systems in a timely manner.
  • Maintain the flow of both electronic and hard-copied controlled documents, department files, and resource materials.
  • Other responsibilities include writing document control systems and putting them into action, logging, tracking, and maintaining records.
  • Coordinating document control issues between external subcontractors, service providers, and fulfillment houses, and preparing reports regarding quality issues.
  • Document control specialists must recognize problems, recommend solutions, and put the solutions into action. They must also be able to maintain confidentiality as they interact with all levels of an organization.
  • Edit and develop documentation as identified to support project processes.
  • Review change orders and supplier records for completeness and accuracy.
  • Maintain numerous quality system logs as defined per project.
  • Maintain external documents (standards) to ensure the company complies with all applicable standards and regulations
  • Communicate with Suppliers to obtain pertinent information required per project.
  • Perform supplier assessments in accordance with the company's and client's SOPs
  • Maintain Master Supplier Log as well as logs that pertain to active projects. This includes notification when certification is expired, or an audit is due.
  • Complete projects (including system enhancements) in a manner consistent with corporate objectives.
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

EDUCATION REQUIREMENTS : High school diploma, with some college or equivalent appropriate industry experience

EXPERIENCE REQUIREMENTS : 1-3 years of experience in the medical device industry.

OTHER QUALIFICATIONS :
  • Ability to perform word processing and create basic spreadsheets. As well as work in Adobe and numerous on-line media.
  • Great attention to detail and orderly focus.
  • Background in editing or document management.
  • Can follow instructions
  • Will be a pro-active problem solver
  • Work to maintain efficiency and quality balance in your work.

***** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.