Quality Control Raw Material Supervisor

TriRx Pharmaceutical Services; Huntsville (AL); On-site; USD 85,000 - 110,000; Full time

Job summary

TriRx Pharmaceutical Services, LLC in Huntsville, AL seeks a Quality Control Raw Materials Supervisor to lead the Raw Materials department in daily laboratory operations and support the production schedule.

The role combines hands-on analytical work with people management, driving quality excellence, CAPA, and method transfer activities while ensuring documentation and training compliance.

Qualifications

• Bachelor’s degree in Chemistry or related field; or PhD with 2+ years in analytical lab.
• Experience with chromatographic equipment and method validations.
• Familiarity with FDA GMP/GLP/GCP.

Responsibilities

• Lead day-to-day activities of the Raw Materials department.
• Supervise raw material chemists and support production schedule.
• Develop quality excellence initiatives and CAPA.
• Perform method transfers and validations and investigations.
• Ensure proper documentation and training compliance.

Skills

Chromatography

Project Management

Analytical lab experience

MS Office

Education

Bachelor’s degree in Chemistry

PhD in Chemistry

Tools

Chromatographic equipment

Integration software

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Control Raw Material Supervisor

Quality Control Huntsville, AL Site, Huntsville, AL, US 1 Attachments

2 days ago Requisition ID: 1130

Job Summary - a concise overview of the job

A Raw Material Supervisor provides team leadership in the day-to-day activities of the Raw Material department. Directly supervises raw material chemists in the ongoing effort to support the production schedule and product quality requirements. Develops and implements quality excellence activities and identifies and executes continuous improvement opportunities for the department. Utilizes established methods and procedures and laboratory equipment to perform the analytical testing and ensure all products released are safe and efficacious. Develops, performs, and summarizes method transfer and validations, and conducts laboratory investigations. This is a working supervisor position, as the individual will still perform analytical duties as needed. This individual will need to be able to adjust planning and schedules as needed, to support a dynamic production schedule.

Scope of Authority - span of control (work unit, site, department, division, etc.) , monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

The Raw Materials Supervisor operates within the Analytical Quality Control Laboratory, under the direction of the Quality Organization.

The Raw Materials Supervisor has no budget/spend authority, but acts as SME in the selection of materials and equipment.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Floor

Operations

• Maintain an organized database of raw material testing and history in order to ensure annual material quality commitments are maintained
• Schedule day-to-day activities of analysts in the raw materials department
• Oversee Laboratory Technician(s) to ensure the analytical laboratory maintains an adequate stock of consumables and reagents to support commercial activities.
• Represent the raw materials group in cross-functional activities, assessing impacts to the team and identifying gaps in support
• Represent Quality Control, as needed, for raw material specific requests and queries by clients. Attend client tag-ups as needed to provide support for raw materials.
• Work closely with other internal departments, such as Scheduling, Purchasing, and Operations to ensure the QC Lab has adequate resources and availability to support the production schedule.
• Creates, develops, and executes protocols for method transfers, method validations.
• Coordinate transfers (with Analytical Tech Services) for raw materials moving to a commercial status.
• Conduct and perform investigations for analytical events.
• Multitask projects while maintaining high levels of accuracy
• Perform other duties as assigned

60%

Non-Conforming Events

• Complete complex laboratory investigations with a thorough understanding of root cause analysis and required CAPAs. Be able to fully complete and document NCRs / Events, and assign associated risk levels.

20%

Process Improvement

• Work in cross functional teams as necessary to complete projects, transfers, and investigations. Function as laboratory representative for facility and company-wide initiatives.
• Act as the Quality Control liaison for specific projects and the associated clients.

20%

Compliance

• Maintain current training compliance on assigned SOPs and company policies.
• Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible.
• Be familiar with operation of all lab equipment, as the raw materials group utilizes all equipment in the lab
• Complete department trend reviews and analyses.

Safety

• Operate under all corporate safety requirements at all times, including use of PPEs and adherence to company policies in handling of hazardous substances

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Bachelor’s degree in Chemistry or Related Field , with a proven ability to display aptitude for all the tasks under Responsibilities, or
• pH.D. in Chemistry or Related Field, with a minimum of 2 years’ experience in an analytical laboratory.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Knowledge of FDA regulations
• Familiarity with Good Manufacturing Practices (GMPs)
• Familiarity with analytical laboratory operations and associated safety requirements
• Possess a solid understanding of column chemistry with ability to troubleshoot most problems without support.

Skills

&

Abilities

• Experience with chromatographic equipment and integration software
• Experience with Microsoft Office Suite of Products, including Word, Excel, and Teams
• Analytical laboratory experience
• Project Management

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances
• Some work may require extended periods of time standing at a lab bench
• Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e. accurately read meniscus)

Attachments (1)

Quality Control Supervisor Raw Materials TriRx HSV Job Description.docx