Spec 1, Quality Assurance
Previous Job
Spec 1, Quality Assurance
Ref No.: 18-03409
Location: Vernon Hills, Illinois
Position Type:Contract
Job Category:Biotech/Pharmaceutical
Hiring a Contract Quality Associate
Duration: 3+ Months
Client Location:  Vernon Hills, IL
Work Schedule:  40 Hours Weekly
Pay Rate:  $19.00 Hourly
Benefits: ACA Compliant Medical Insurance
  • Incumbent will support the review and entry of data to populate the GUDID database for both initial upload and product information maintenance. Additionally, they will support the review of product labels with respect to compliance with FDA UDI requirements. Incumbent is also responsible for executing documentation management tasks associated with project Equinox.
  • Incumbent will be accountable for the execution of specific tasks with moderate discretion and with supervisor oversight.
  • Incumbent will be trained on all tasks which may include:
    • Data remediation: Compile data from various databases and enter data into Trackwise data tool for entry into GUDID database
    • Label Verification: Ensure data accuracy between labels and master UDI data
    • Perform Trackwise record reviews
    • Documentation Control: Assist in ensuring project traceability per the appropriate change control process (V. Mueller DCN, IS DCR).
    • Assist Project Manager in other daily activities related to the UDI implementation and maintenance activities
    • Locating documentation in the document control center,
    • Comparing/verifying limited content against other sources,
    • Transcribing data into spreadsheet format,
    • Filling out document change notifications (DCNs)
    • Routing DCNs for approval
    • Copying and filing.
  • Assist Project Manager in other daily activities related to Equinox or UDI implementation maintenance activities
  • High School Diploma required; Higher education preferred
  • Reliable, Excellent attention to detail even during repetitive tasks, Strong verbal and written communication skills, organizational skills, ability to work in a team. Proficiency to learn basic user functions of software systems not previously known.
1-3 years technical experience in the medical device or related field; or previous internship and/or related consulting experience
  • Work experience in an office environment
  • Preference to individuals with work experience in the medical device or pharmaceutical industry and with experience in good documentation practice (GDP)
  • Knowledge of US FDA Medical Device regulations is a plus
  • Proficient in Microsoft Office Software, particularly Microsoft Outlook, Excel, and Word. Moderate to high Microsoft Excel knowledge. Experience with SAP a plus.
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-03409 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).

**Candidates must complete background and drug screenings before starting any assignment.
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