Novan
  • 14-Sep-2017 to 31-Oct-2017 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

The Quality Assurance Document Control Specialist will provide operational support to the Company including the filing and maintenance of paper and electronic documents. This work involves documentation, retention, retrieval, and archival of site-wide records and maintaining the Company's electronic document management system (EDMS) according to Novan policies and procedures. The Document Control Specialist shall adhere to the Company's quality system including but not limited to the applicable standards, policies, and procedures in the areas of responsibility defined in this job description.

 

Principal Responsibilities:

  1. Act as a gatekeeper for maintaining complete and accurate records such as the following types of documentation including but not limited to; regulatory documents, quality agreements, SOPs, employee training records, master batch/packaging records, labeling, analytical science protocols/reports, test methods/protocols/reports, development and validation protocols/reports, specifications, raw material and components, audit reports, laboratory notebooks, vendor correspondence, etc.
  2. Assist Document Control Manager with management of the hard copy (paper) records in the Document Control Room (DCR) by following and maintaining the established file structure, creating labels, archiving Quality documentation and management of shipping and receiving records to/from off-site storage facilities (i.e., Iron Mountain).
  3. Maintain paper and electronic files in the Company's quality document management system in accordance with Company document lifecycle policies and procedures, federal regulations, and audit requirements.
  4. Support implementation and company-wide training efforts associated with the deployment of the Electronic Document Management System (EDMS).
  5. Navigate the EDMS (MasterControl) for purposes of accessing information and records in an expedient manner including performing searches, routing documents, collaborating within documents, and generating reports.
  6. Responsible for creating document templates and assisting MasterControl Users with template usage.
  7. Manage the entire document lifecycle including document issuance, tracking of document numbers, format review, routing documents for review and approval, scanning and filing documents in the EDMS and maintain hard copy original files as applicable.
  8. Facilitate the document revision process as outlined per the Company's document lifecycle policies and procedures to ensure timely revision of Novan documents.
  9. Assign company-wide training curriculum per departmental management requirements and maintain accurate and up to date training records.
  10. Support the Document Control Manager with new user training for EDMS (MasterControl), group training sessions, one-on-one (when required), and general training requirements to meet company-wide need
  11. Perform duties on site, on time, and within the Company's normal business hours listed in the Employee Handbook.  Perform other duties as assigned

 

Qualifications:

Education:

  1. Two year associates degree required. Bachelor's degree strongly preferred in a life sciences discipline or equivalent.

Experience:

  1. 2 -5+ years of experience in relevant administrative and document management work.
  2. Experience formatting, publishing, organizing, and maintaining files.

Skills:

  1. Trustworthy, flexible, dependable, and self-motivated with the ability to work independently and as part of a team.
  2. Superior attention to detail; highly organized and process-oriented.
  3. Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills.
  4. Ability to work in a cross-functional team environment and interact with all levels withing the company.
  5. Effectively prioritizes workload and managse time to complete multiple projects within established timelines and goals in a fast-paced environment.
  6. Expertise in Microsoft Office and an Electronic Document Management System (EDMS) is required. MasterControl strongly preferred.

 

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.

 

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

 

EEOC:

Novan, Inc. is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

Novan
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    By clicking the button above, I agree to ApplicantPro's Applicant Information Use Policy.

  • Sign Up For Job Alerts!

.
Logo Home Company Technology Product Pipeline Investors & Media