Documentation Coordinator in Raleigh, NC at Volt

Date Posted: 12/5/2019

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Raleigh, NC
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
    12/5/2019
  • Job ID:
    186122
  • Contact Name
    Volt Branch
  • Phone
    (919) 829-1660

Job Description

We have an exciting Documentation Coordinator position with a growing pharmaceutical company in North Raleigh

The Documentation Coordinator maintains the plant wide systems that track critical documents generated within the facility. These critical documents include but are not limited to SOPs (Standard Operating Procedure), batch records, and logbooks.

Responsibilities

Position will be responsible for the following:
- Assures that critical documentation is created, reviewed, approved and filed in accordance with company and regulatory policies.
- Oversees the process of generating, approving, numbering, changing, distributing, storing and archiving critical controlled documents.
- Ensures the integrity of the system or systems tracking the critical documents.

-Liaise with all functional groups within the facility to assist in the creation, tracking and control of documents to ensure consistency within the document control system.
 -Performs periodic audits of the system for trace ability, reliability, system adequacy, and procedural compliance.
- Prepare document status reports to be reviewed by all responsible functional groups to expedite the action necessary for completing all associated documents required to close the record.
-File all controlled documents.
-Plays a supporting role in Regulatory and Customer Audits.
- All other documentation related duties as assigned.

Key Responsibilities

-Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

-Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Volt has been a leader in the Staffing Industry for 60 years and currently has more than 100 branches nationwide to serve both our clients' and candidates' needs. We connect office professionals with leading employers in the area. Whether you are looking for a contract/temporary position or a direct hire, we are here to serve you. Find out more about us by visiting www.volt.com.

Volt is an Equal Opportunity Employer.

Requirements

- High School Diploma/GED required.
- 1-3 years work experience in a Pharmaceutical company or other FDA regulated industry .
- Associate’s degree, preferred.
- Strong computer skills to include but not limited to Microsoft Office (MS Word, Excel, Access, and PowerPoint). TrackWise skills are a plus.
- Demonstrates excellent communication skills both written and verbal.
- Experienced in problem solving with emphasis on strong interpersonal skills necessary to interact across various functional groups.
- Organizational skills required for quick response and status reporting of critical control documents.