QC Laboratory Document Reviewer

HTI has an immediate opening for a Quality Control Lab Document Reviewer with a large pharmaceutical manufacturer in Greenville, SC. This is a permanent, direct hire position, and the company offers excellent comprehensive benefits.

The hourly pay rate is $27.25/hour

** This is a weekend shift position - hours are Friday, Saturday, and Sunday from 7am - 7:30pm.

Requirements:

• Must have a Bachelors’ degree in Chemistry or Biology
• Must have 2 years of experience in a similar lab role, preferably with cGMP, FDA, and/or pharmaceutical experience
• Must have strong writing and communication skills, as well as a high level of accuracy and attention to detail when reviewing laboratory documentation
• Experience with Chromatographic software such as LIMS, OpenLab, or Empower is preferred
• Intermediate Microsoft Office skills required
• Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems; analytical ability / problem solving

Job Duties:
The QC Document Reviewer will be responsible for reviewing lab and testing documentation for bulk and packaged products, raw materials and stabilities.

• Review the analytical documentation of drug product and drug substance testing performed by QC analysts in a timely and compliant manner per specifications and USP methodology to ensure finished goods are acceptable for distribution.

• Ensure that QC documentation of all analyses was performed per cGMP and FDA guidelines.

• Perform monthly reviews of QC logbooks to ensure all entries are cGMP compliant.

• Verify entry of data into LIMS system.

• Review instrumentation and equipment calibrations on an as needed basis.

• Responsible for document review of routine laboratory functions to support manufacturing/production in order to ensure that production schedule is met.

• Reviewer II: Advise QC Chemists on documentation practices and corrections with management oversight.

• Reviewer II: Assist in writing and revising Raw Material Specifications and Finished Product and Stability Specifications to ensure cGMP compliance.

Benefits include:

• Medical, Dental, Vision, EAP
• 401k Match
• Onsite Wellness Center
• Tuition Reimbursement
• Paid Holidays
• Progressive PTO Plan

INDPRO