Chemist III/Sr. Chemist Raw Materials

MedPharm•Durham, NC

4d•Onsite

About The Position

The Chemist III/Sr. Chemist Raw Materials ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients.

Requirements

Minimum BA or BS in a scientific discipline required
Minimum 5-8 years of Analytical chemistry experience with a cGMP/GLP environment, preferably at a CDMO or pharmaceutical company.
Knowledge of cGMPs
Good communication, organization and computer skills are required.
Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired.
Ability and willingness to work additional hours as required by business need
At least 5 years’ experience in a CRO environment
Experience with USP, EP and JP monographs.
Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size.
Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
Excellent verbal and written communication skills
Ability to work with minimal supervision
Experience in Data Review of Analytical data per GDP guidelines.
Proven ability to review and evaluate the compliance and completeness of analytical data.
Able to multi-task productively, applying time management processes and procedures effectively.
Works toward common goals by supporting, encouraging, and sharing information with colleagues.
Strong analytical skills and ability to understand business and financial implications of contracts
Self-directed

Responsibilities

Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines.
Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements
Interact with third party laboratories for microbial and analytical testing of raw materials
Generate and/or review shipping paperwork for third part 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
Review third party laboratory investigations and protocols.
Execute intermediate to advanced chemical and instrumental testing of raw materials using HPLC, GC, FTIR, UV-Vis, Karl Fischer titration, and wet chemistry.
Ensure all testing meets compendial standards (USP/EP/JP) and regulatory expectations. Conduct peer reviews of data, Certificates of Analysis (COAs), and laboratory logbooks.
Author and review GMP documentation including Standard Operating Procedures (SOPs), protocols, deviations, Corrective and Preventive Actions (CAPAs), and change controls.
Provide technical guidance to junior analysts. Lead method verification, validation, and method transfer activities for incoming raw materials.
Oversee the calibration, maintenance, and troubleshooting of laboratory equipment.
Other duties as assigned