Document Control Specialist

Location
Redwood City, CA
Posted
Apr 13, 2021
Ref
356701
Hotbed
Biotech Bay
Required Education
High School or equivalent
Position Type
Full time

Are you looking for a unique opportunity with a small, innovative and close-knit team that values integrity, mutual respect and a work-life balance? Do you enjoy a challenging and changing environment, and like to roll up your sleeves to get things done?

Cannon Quality Group is looking for a highly organized Team Member to work in a Client-facing role, focused on helping implement smarter Quality Management systems for our client companies. If you are a self-starter with excellent communication skills and are motivated to work hard and have an affinity for highly detailed work, this position may be a very good fit for you. The best candidate will be flexible with a sense of urgency, and display personal characteristics that emulate our Company Core Values of Teamwork, Integrity, Accountability and Adaptability. Candidates should also have a genuine interest in Quality as a career.

When applying, please provide a cover letter (which tells us something about you that is not in your resume), resume and complete the survey. Failure to follow directions will immediately eliminate you from consideration (it's our most simple of screens)!

PURPOSE OF JOB:   Maintain compliance in the areas of document control and supplier control for company as well as clients in support of company’s strategic plan.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Act as Document Control for numerous clients in order to process all documents through both internal and external systems in a timely manner
    • All client COs/DCOs/DCRs are closed in a timely manner
    • Own ensuring the follow up actions make it to completion
    • Maintain a computer database of all filed documentation that ensures fast retrieval of documents
    • Maintain the flow of both electronic and hard-copied controlled documents, department files and resource materials
    • Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
    • Coordinating document control issues between external subcontractors and service providers
    • Maintain Master Document Control Log and Files
    • Review change orders and for completeness and accuracy
  • Maintain all client training as well as CQG consultants’ internal training up to date and accurate
    • All logs and files are to be maintained
  • Maintain all client as well as CQG external standards up to date and accurate.
    • All logs and files are to be maintained
    • Maintain external documents (standards) to ensure the company complies with all applicable standards and regulations
  • Other responsibilities include:
    • Edit and assist in drafting new Quality System Procedures
  • Document control specialists must be able to 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.
  • Be involved in the training of other team members
  • 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 
  • Ability and willingness to learn/ use new software programs
  • A high attention to detail and orderly focus
  • Background in editing or documentation management
  • Can follow instructions
  • Will be a pro-active problem solver
  • Work to maintain efficiency and quality balance in your work
  • Team player
  • Good communicator
  • Ability to prioritize across numerous projects and varying dates

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