QC Chemist I, Raw Materials

MedPharm•Durham, NC

4d•Onsite

About The Position

The Quality Control Raw Materials Chemist I performs testing using a variety of analytical techniques. The successful candidate ensures that Testing and Documentation is compliant with GMP regulations and internal procedures. The ideal candidate will additionally possess superior communication skills. The position will be operating within a GMP environment for a Quality Control CDMO.

Requirements

Minimum BA or BS in a scientific discipline required
Minimum 2 – 4 years in a Quality Control setting for Raw Materials
Knowledge of cGMPs
Good communication, organization and computer skills are required.
Knowledge of Empower and Microsoft Office (Excel, Word) is required
Experience with testing per USP, EP, BP, and JP monographs.
Ability to interpret various compendial guidelines to ensure specifications meet regulatory requirements.
Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
Ability to work with modest supervision
Able to multi-task productively, applying time management processes and procedures effectively.
Self-directed

Nice To Haves

LIMS knowledge is desired.
Ability and willingness to work additional hours as required by business needs
Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators, Coulometric Karl Fischer Titrators, Melting Point Apparatus, Muffle Furnace, UV-Vis, Refractometers, and Particle size.

Responsibilities

Perform testing of raw materials, packaging components, and other samples.
Conduct routine analytical experiments using established analytical methods and procedures.
Data entry into reports, as directed by senior laboratory personnel.
Verify simple transcription processes, such as checking accuracy of calculations and reviewing daily equipment verifications for compliance.
Support testing for investigations for OOS, OOT, and aberrant results and troubleshooting.
Review and maintain laboratory notebooks.
Ensure data collected is processed and submitted for review in a timely manner.
Maintains laboratory inventory of chemicals, standards, and consumables and orders materials as necessary.
Aid in investigations for OOS, OOT, and aberrant results and troubleshooting by assisting in root cause determination.
Generate and/or review shipping paperwork for third party testing and prepare samples for shipment.
Create purchase requisitions for lab supplies and third-party testing.
Perform weekly laboratory audit inspections.
Perform sampling of raw materials as needed.
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.