Quality Control Raw Material Supervisor

TriRx Shawnee LLC•Huntsville, AL

About The Position

The Raw Material Supervisor provides team leadership for the day-to-day activities of the Raw Material department and directly supervises raw material chemists. The role supports production schedules and product quality requirements by developing and implementing quality excellence activities, identifying and executing continuous improvement opportunities, and using established methods, procedures, and laboratory equipment to conduct analytical testing and ensure released products are safe and efficacious. The supervisor develops, performs, and summarizes method transfers and validations and conducts laboratory investigations. This is a working supervisor role that also performs analytical duties as needed and adjusts plans and schedules to support a dynamic production schedule. The position operates within the Analytical Quality Control Laboratory under the direction of the Quality Organization. It has no budget or spending authority, but serves as a subject matter expert in material and equipment selection. Responsibilities include maintaining raw-material testing records and history; scheduling analysts; ensuring laboratory consumables and reagents are adequately stocked; representing the raw materials group in cross-functional work and client requests; coordinating with Scheduling, Purchasing, Operations, and Analytical Tech Services; developing and executing method transfer and validation protocols; conducting investigations; completing and documenting non-conforming events and CAPAs; supporting projects and process improvements; maintaining training and documentation compliance; reviewing department trends; and following corporate safety requirements. The role requires a bachelor’s degree in Chemistry or a related field with demonstrated aptitude for the responsibilities, or a Ph.D. in Chemistry or a related field and at least two years of analytical laboratory experience. Relevant knowledge includes FDA regulations, GMPs, analytical laboratory operations and safety, column chemistry, troubleshooting, and root cause analysis. Candidates should have experience with chromatographic equipment and integration software, Microsoft Office, analytical laboratory work, and project management. Physical requirements include correctly wearing PPE when handling hazardous substances, potentially standing at a laboratory bench for extended periods, and accurately measuring and reading solution volumes.

Requirements

Bachelor’s degree in Chemistry or a related field, with demonstrated aptitude for the responsibilities; or a Ph.D. in Chemistry or a related field with a minimum of two years of analytical laboratory experience.
Knowledge of FDA regulations.
Familiarity with Good Manufacturing Practices (GMPs).
Familiarity with analytical laboratory operations and associated safety requirements.
Solid understanding of column chemistry and ability to troubleshoot most problems without support.
Knowledge of root cause analysis.
Experience with chromatographic equipment and integration software.
Experience with Microsoft Office products, including Word, Excel, and Teams.
Analytical laboratory experience.
Project management skills.
Ability to wear appropriate PPE correctly while handling hazardous substances.
Ability to stand at a laboratory bench for extended periods when required.
Visual ability to accurately measure and read solution volumes in volumetric apparatus, including reading the meniscus.

Responsibilities

Provide team leadership and directly supervise raw material chemists in day-to-day department activities.
Support production schedules and product quality requirements, adjusting plans and schedules as needed.
Maintain an organized database of raw material testing and history to support annual material quality commitments.
Schedule day-to-day activities of raw materials analysts.
Oversee laboratory technicians to ensure adequate stocks of consumables and reagents.
Represent the raw materials group in cross-functional activities, assess impacts to the team, and identify support gaps.
Represent Quality Control for raw-material-specific requests and client queries, and attend client tag-ups as needed.
Coordinate with Scheduling, Purchasing, and Operations to ensure the QC laboratory has resources and availability to support production.
Create, develop, and execute method-transfer and method-validation protocols.
Coordinate raw material transfers to commercial status with Analytical Tech Services.
Conduct analytical investigations and complete complex laboratory investigations, including root cause analysis, CAPAs, NCRs/events, documentation, and risk-level assignments.
Multitask projects while maintaining accuracy.
Work on cross-functional projects, transfers, and investigations, and represent the laboratory in facility and company-wide initiatives.
Act as the Quality Control liaison for specific projects and associated clients.
Maintain current training compliance on assigned SOPs and company policies.
Document and record work accurately and legibly so analyses are traceable and reproducible.
Remain familiar with laboratory equipment used by the raw materials group.
Complete department trend reviews and analyses.
Follow corporate safety requirements, use required PPE, and comply with policies for handling hazardous substances.
Perform analytical duties as needed and other duties as assigned.