The Advanced Quality Control Chemist plays a critical role at the Northridge site by performing and completing complex and routine analytical procedures. These procedures are essential for the testing and evaluation of Raw Materials, Hard Goods, and Finished pharmaceutical products.
The Advanced Quality Control Chemist identifies, investigates technical or product quality concerns as they arise and collaborate with other departments about product quality issues with relevant teams to facilitate timely solutions. The Advanced Quality Control Chemist is tasked with leading safety initiatives and facilitating training sessions. In pursuit of these objectives, the Chemist employs industry-standard methodologies and tools, including Six Sigma, LEAN, and Statistical Process Control (SPC). Additionally, demonstrating expertise during audits is essential to ensure compliance with both regulatory requirements and internal standards.
Role Responsibilities
- Sample Preparation and Analysis
Prepare sample solutions, standards, and reagents required for laboratory testing. Conduct wet chemical and instrumental analyses utilizing equipment and techniques such as FTIR (Fourier Transform Infrared Spectroscopy), HPLC (High Performance Liquid Chromatography), UV Spectrophotometer, Dissolution testing, Instron, Texture Analyzer, and Gas Chromatography. The Senior Chemist is knowledgeable on these analytical instruments and is able to help others with troubleshooting. - Materials Testing and Documentation
Analyze packaging materials, raw materials, and finished products according to USP/NF/EP Compendia and approved test methods and specifications. Review and update laboratory documentation via MOC including SOPs (Standard Operating Procedures), worksheets, specifications, work instructions, and methods to ensure they reflect current processes. The Senior Chemist will also lead more complex process improvements in the laboratory. - Training and Collaboration
Complete one-on-one and group training sessions with peers. Own the introduction of new analytical techniques and equipment to the quality control laboratory. - Testing Cycle Management
Meet multiple testing cycle time requirements through testing and reviewing documentation. - Equipment Maintenance and Quality Support
Perform calibration and maintenance of quality control laboratory equipment. Lead in resolving non-conformances and investigations in the quality control laboratory with guidance. Ensure timely completion of CAPA (Corrective and Preventive Actions). - Work Flexibility and Safety
Work flexible hours as needed to support production demands. Operate in a safe manner, taking responsibility for personal safety and the safety of others. Participate in proactive safety programs (OTSS, S&A), raise documentation for safety incidents (NMs & Mis), and complete safety training as required.
Basic Qualifications
- Bachelors degree or higher in a science discipline from an accredited university
- or minimum of 10 years of analytical testing experience in pharmaceutics without a degree
- Minimum of 5 years of analytical testing experience
Preferred Qualifications
- Bachelors degree or higher in Chemistry from an accredited university
- Basic understanding of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
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