Apply on Employer Site

Traditional Medicinals · 1 day ago

Quality Manager

Rocky Mount, VA

Full-time

Onsite

Senior Level

6+ years exp

Traditional Medicinals is seeking a Quality Manager to oversee the daily operations of the Quality department. This role is responsible for ensuring compliance with regulatory requirements and the effectiveness of the quality management system while managing staff and supporting various departments.

Alternative MedicineManufacturingSustainability

Hiring Manager

Mickele Carpenter

Responsibilities

Manage and perform the evaluation of purchased raw materials, in-process testing, and finished goods for final batch disposition

Maintain the Company’s quality management system by providing oversight and input into the relevant quality systems and standards including Change control, Documentation systems, Quality procedures, Standards and policies, Product complaint management, Internal and external audit programs, Corrective Action and Preventative Action, Material Review Boards, Vendor Risk Management, Calibrations and maintenance, Equipment and computer system validation and commissioning

Hire, manage, and develop Quality department staff and support the company’s goals and objectives

Set and communicate priorities to staff

Ensure continuous improvement and effectiveness of the quality management system

Assist in the development and implementation of standards, methods and procedures for testing and inspection of ingredients, packaging material components, and finished products

Collect, analyze and summarize information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations

Provide support to the daily operations of Quality department

Perform final review and approval of records, documentation, and reports

Manage and support third party inspections and audits and follow up activities

Develop, manage, and deliver training plans for Quality department personnel

Perform maintenance, data entry, and analysis in various electronic systems utilized by the company

Drive continuous improvement programs to lower testing costs, reduce turnaround times, and provide a valued product for internal and external customer

Routinely review the gap analysis resulted from internal audits and address compliances with appropriate team members

Investigating customer complaints

Member of site development group with primary responsibility for quality recommendations regarding laboratory and factory and equipment design

Support and participate in the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met efficiently and economically

Develop and conduct appropriate cGMP 21 CFR part 111 training and compliance for all levels of personnel involved in the manufacturing and release of raw materials and final product

Provide leadership on Food Defense teams

Other duties and projects as assigned

Perform duties for the first year of: Sanitation Supervisor, Quality Specialist – Batch Records, Quality Specialist – Document Control, Lab Tech - Sampler

Qualification

CGMP knowledgeQuality Management SystemQuality Control methodologiesRegulatory requirements knowledgeContinuous improvement methodologyProject management experienceStaff managementAnalytical skillsMS Office skillsQuality software platformsERP systemsCommunication skillsInterpersonal skills

Required

BA/BS in a scientific discipline or equivalent education/experience

Six years' progressive experience in Quality in food, beverage, dietary supplement, or other regulated industry

Two years' supervisory experience in a manufacturing setting or equivalent

Strong knowledge of cGMPs in a regulated industry

Strong knowledge of regulatory requirements for the manufacturing of food, beverage, dietary supplements, or Over-the-Counter (OTC) drugs, dietary supplements (21 CFR part 111) preferred

Strong current knowledge of Quality Control and Assurance methodologies

Demonstrated ability to manage and develop staff

Able to collaborate, influence and work effectively across multiple departments and locations

Able to independently solve problems and make decisions based on company and/or quality policy

Ability to read, interpret and apply quality standards, SOP's, specifications and work instructions

Strong data gathering, metrics development, and report generation skills

Strong analytical and problem-solving skills

Strong organization skills and attention to detail

Strong verbal and written communication skills

Strong interpersonal skills

Commitment to and ability to demonstrate TM's Company values: humility, respect, quality, collaboration, innovation and sustainability

Intermediate MS Office skills