Quality Supervisor

Traditional Medicinals; Rocky Mount (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Traditional Medicinals is seeking a Quality Supervisor to lead the Quality team, ensuring in-process quality activities and regulatory compliance for ingredients, blends and finished goods. This role ensures lab activities are accurate, documented, and aligned with cGMP requirements.

Responsibilities include supervising QC and lab staff, maintaining instrument readiness, leading OOS investigations, and collaborating across Production, R&D, Procurement and Planning to meet priorities.

Qualifications

• BA or BS in scientific discipline or equivalent education/experience.
• Two years’ Quality experience in a regulated industry.
• Four years’ hands-on QC or analytical chemistry experience in a regulated industry.
• 2+ year supervisory experience in a comparable setting.

Responsibilities

• Supervise day-to-day activities and training of Quality department personnel including quality inspectors and laboratory personnel.
• Ensure timely and accurate inspection, testing and disposition of QC samples (e.g., components, ingredients, blends, finished products, pre-ship samples, retest materials, R&D materials).
• Ensure all lab instrumentation/equipment is functioning properly, validated for use, and appropriately scheduled for preventative maintenance and calibration.
• Lead OOS investigations with focus on identifying root causes and taking corrective action where appropriate; document and communicate non-conformances to stakeholders.
• Ensure accuracy and completeness of documentation (e.g., batch records, evaluation forms, deviations, NCMRs, Corrective Actions, including electronic/digital records).
• Partner with Production, R&D, Procurement and Planning, and other departments to understand production or corporate priorities and adjust personnel and department priorities as needed.

Skills

cGMP knowledge

Analytical methods

Laboratory equipment

Staff development

Communication

MS Suite

ERP/WMS systems

Education

Bachelor's degree in scientific discipline

Tools

MasterControl

Ignition

Redzone

Job description

SUMMARY

The Quality Supervisor supervises Quality staff in their day-to-day responsibilities. Ensures in-process quality functions are executed, and manufacturing operations are in compliance with company policies, procedures, and applicable cGMP requirements. Ensures timely disposition of incoming ingredients, component, blends, and finished goods. This position also ensures lab activities are compliant, accurate and documented.

ESSENTIAL FUNCTIONS

• Supervise day-to-day activities and training of Quality department personnel including quality inspectors and laboratory personnel.
• Ensure timely and accurate inspection, testing and disposition of QC samples (e.g., components, ingredients, blends, finished products, pre-ship samples, retest materials, R&D materials)
• Ensure all lab instrumentation/equipment is functioning properly, validated for use, and appropriately scheduled for preventative maintenance and calibration
• Lead OOS investigations with focus on identifying root causes and taking corrective action where appropriate; document and communicate non-conformances to stakeholders
• Ensure accuracy and completeness of documentation (e.g., batch records, evaluation forms, deviations, NCMRs, Corrective Actions, including electronic/digital records)
• Partner with Production, Research & Development, Procurement and Planning, and other departments to understand production or corporate priorities and adjust personnel and department priorities as needed
• Ensure that processes and methods utilized in the laboratory are compliant and accurate
• Ensure that department personnel are properly trained and qualified to perform their job
• Ensure compliance with current company, departmental and regulatory requirements
• Ongoing assessment of facility operations considering continuous improvement
• Assists and performs data collection and analysis of QC metrics
• Generates or revises controlled documents such as SOPs and data forms
• Lead for special projects as assigned
• Perform maintenance, data entry, and analysis in various electronic systems utilized by the company
• Perform Quality Inspector duties as backup when needed
• Site QMS systems subject matter expert (e.g. Redzone, Master Control, Ignition, etc.)
• Other duties as assigned
  SUPERVISORY/BUDGET
• Direct supervision of Quality department inspectors and lab technicians
• No direct budgetary oversight
• REQUIREMENTS

Education and Experience:

• BA or BS in scientific discipline or equivalent education/experience
• Two years’ Quality experience in a regulated industry
• Four years’ hands-on QC or analytical chemistry experience in a regulated industry
• 2+ year supervisory experience in a comparable setting
• Project management experience preferred
  Knowledge/Abilities/Skills:
  
• Strong knowledge of cGMP requirements and quality systems within a regulated industry, such as food, dietary supplements, cosmetics, or pharmaceuticals, required. Knowledge of regulatory requirements for dietary supplements (21 CFR Part 111) preferred.
• Technical proficiency in analytical methodologies
• Strong knowledge of laboratory protocols and equipment
• Demonstrated ability to manage and develop staff
• Able to collaborate, influence and work effectively across multiple departments
• Ability to read and interpret regulatory documents
• Able to independently solve problems and make decisions based on company and/or quality policy
• Ability to effectively manage competing priorities with the drive and ability to meet deadlines
• Excellent organization skills and attention to detail
• Strong verbal and written communication skills
• Commitment to and ability to demonstrate TM’s Company values: humility, respect, quality, collaboration, innovation and sustainability
• Intermediate MS Suite
• WMS/ERP systems preferred
• Travel Requirements:
• Occasional travel to California or 3rd party test labs or supplier(s)
• Work Environment:
• Works often in the QC laboratory with hazardous chemicals present, requiring competence and familiarity with safe handling and storage of acids, bases and solvents.
• Works often in production area(s)warehouse, must follow GMP requirements and safety precautions for each area.