Clinical Label Quality Associate/onsite-hybrid

The position is onsite in North Chicago

Clinical Label Quality Associate

Under template title(in Fieldglass Quality Assurance (QA) Compliance Specialist I)

ONSITE-Lake County 33-36.00 an hour w2 contract
Contract: 1 Year

This position is responsible for creating and approving labels for Clinical Supplies used in Clinical Studies. Attention to detail is of paramount importance. This position compares different source documents and ensures that the information is consistent and accurate with the clinical label. In addition, this position requires use of a design program to create the .pdf proof of the label design. Additionally responsible for implementing and maintaining the effectiveness of the quality system; reviews, proofreads, and approves Clinical Labels for accuracy and compliance to regulatory requirements. Reviews labeling for consistency with similar or related product labels. Communicates and coordinates labeling and documentation approvals with worldwide affiliates. Interaction and professional communication with business partners around the world is required. All communication is in English. Must be able to rearrange priorities on short notice to react to business needs.
Education: Bachelor’s Degree or equivalent experience is required, preferably in Science, English, Business, or related field to ensure accuracy of highly technical information used by Clinical Operations and regulated by the FDA.
Background: Knowledge of regulations and standards a plus. Must have the ability to problem solve, manage multiple projects simultaneously, influence internal and external groups and provide leadership. The incumbent should have strong organizational and human relations skills to deal with various levels of individuals and functional areas within the division. Previous experience working within a change control system is helpful. Accountability / Scope: Labeling and documentation for clinical supplies must be completed accurately and within the designated timelines.

Added notes from the manager: Must have strong organizational and clear communication skills. Must be willing to work OT when needed. Project management and QA experience nice to have. Team oriented, attention to detail, willing to change priorities to help team.

3) Length of the assignment: 1 year
4) What hours and days will this person be working: M-F, 8 work hours
5) Does this position offer the ability to work remotely on a regular basis or is it an on-site role: On-site initially, then hybrid
Location: North Chicago, IL 60064
6) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Attention to detail/Organizational Skills
b. Required Skill 2: Communication
c. Required Skill 3: Project Management/Problem Solving
d. Required Skill 4: Teamwork
e. Required Skill 5: Basic to Intermediate skills with computers (Individual will be required to use Smartsheet, an electronic inventory and label design systems, and must be able to quickly learn how to navigate)
7) What years of experience, education, and/or certification is required? Bachelor’s Degree or equivalent experience is required (4+ years), preferably in Science, English, Business, or related field.
8) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Prefer 2-3 years of experience in GMP or regulated industry, 4+ years if no Bachelor’s Degree.
9) What is the environment that this person will be working in (i.e. group setting vs individual role)? Individual role, but part of a team that supports each other’s projects as necessary; after training is complete.