HTI has an immediate opening for a Chemistry (QC) 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/hourThis 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