05.01.17
Company Name:
Traditional Medicinal
Company Description:
Traditional Medicinals is an independent company that embraces sustainability, ingredient purity, and social and environmental activism. A Certified B Corporation and California Certified Green Business, we’re the leading seller of wellness tea in the U.S. and the pioneer of the wellness tea category in the U.S. and Canada.
Our roots go back to a third generation herbalist named Rosemary Gladstar, who was raised close to the earth in the farmlands of Northern California. In the late 1960s, while living in the coastal redwood forest, she met community activist and environmentalist Drake Sadler. The young couple was part of a movement of back-to-the-land baby boomers seeking an alternative lifestyle, including natural foods and herbal remedies. Together, they shared a vision for the rebirth of herbalism in North America, and in 1974 they co-founded Traditional Medicinals.
Business Industry:
Manufacturer/Contract Manufacturer/Marketer
Job Title:
Quality Assurance Manager
Experience:
Mid-Senior Level
Job Function:
Quality Assurance
Employment Type:
Full-time
Job Description:
Traditional Medicinals™ is a growing, financially sound, 40-year-old herbal wellness tea company based in Sonoma County, CA. The company manufacturers over 60 varieties of tea in its solar powered Sebastopol facility. Traditional Medicinals™ is proud to be the number one wellness, organic, and fair trade herbal tea company in the US. Traditional Medicinals™ is an independent, mission driven company with a planning horizon extending beyond the next generation. The concept of a triple bottom line, focusing on people, planet, and profits, is part of the Company’s mission and the basis for its success over the past years.
While the company is celebrating 40 years of success, it is not a complacent one. Revenues have tripled over the last five years and it has built a strong and loyal following for delivering herbal medicinal remedies delivered through easy-to-use and tasty teas. While tea has been their strong historical delivery medium, the company continues to explore new ways to deliver healthy organic remedies.
This is a culture where people love thoughtful, open dialogue and idea sharing. It is innovative and respectful and blends a unique culture of respect and creative thinking with high business acumen and customer orientation. It is proactive and self-sufficient.
The company is seeking a talented and experienced individual to manage the Quality function as we enter a new phase of innovation and company growth. This position offers a meaningful opportunity to help refine the Quality Management System while developing and managing the Quality team.
Desired Skills and Experience:
Traditional Medicinal
Company Description:
Traditional Medicinals is an independent company that embraces sustainability, ingredient purity, and social and environmental activism. A Certified B Corporation and California Certified Green Business, we’re the leading seller of wellness tea in the U.S. and the pioneer of the wellness tea category in the U.S. and Canada.
Our roots go back to a third generation herbalist named Rosemary Gladstar, who was raised close to the earth in the farmlands of Northern California. In the late 1960s, while living in the coastal redwood forest, she met community activist and environmentalist Drake Sadler. The young couple was part of a movement of back-to-the-land baby boomers seeking an alternative lifestyle, including natural foods and herbal remedies. Together, they shared a vision for the rebirth of herbalism in North America, and in 1974 they co-founded Traditional Medicinals.
Business Industry:
Manufacturer/Contract Manufacturer/Marketer
Job Title:
Quality Assurance Manager
Experience:
Mid-Senior Level
Job Function:
Quality Assurance
Employment Type:
Full-time
Job Description:
Traditional Medicinals™ is a growing, financially sound, 40-year-old herbal wellness tea company based in Sonoma County, CA. The company manufacturers over 60 varieties of tea in its solar powered Sebastopol facility. Traditional Medicinals™ is proud to be the number one wellness, organic, and fair trade herbal tea company in the US. Traditional Medicinals™ is an independent, mission driven company with a planning horizon extending beyond the next generation. The concept of a triple bottom line, focusing on people, planet, and profits, is part of the Company’s mission and the basis for its success over the past years.
While the company is celebrating 40 years of success, it is not a complacent one. Revenues have tripled over the last five years and it has built a strong and loyal following for delivering herbal medicinal remedies delivered through easy-to-use and tasty teas. While tea has been their strong historical delivery medium, the company continues to explore new ways to deliver healthy organic remedies.
This is a culture where people love thoughtful, open dialogue and idea sharing. It is innovative and respectful and blends a unique culture of respect and creative thinking with high business acumen and customer orientation. It is proactive and self-sufficient.
The company is seeking a talented and experienced individual to manage the Quality function as we enter a new phase of innovation and company growth. This position offers a meaningful opportunity to help refine the Quality Management System while developing and managing the Quality team.
Desired Skills and Experience:
- 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.
- Manages daily operations of the Quality Assurance department. Set and communicate priorities to staff. Support daily operations of Quality Control and Production departments.
- Ensures continuous improvement and effectiveness of the quality management system. Provide 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, CAPAs Corrective Action and Preventative Action, Material Review Boards, and Vendor Risk Management
- Develops quality assurance plans by conducting GMP internal audits. Routinely review the GAP analysis resulted from internal audit and address compliances with appropriate team members.
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
- Manage final review and approval of Master Batch Records, Manufacturing Batch Records, Product Release, SOPs, Change Control Documentation, Audit Reports, Validation Documentation, Product Specifications, R&D Testing Protocols, and Supplier Qualifications.
- Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. Ensure accurate response and documentation of non-conformances and the implementation of appropriate corrective action plans.
- Manage third party inspections and audits, including regulatory inspections, findings and follow-up.
- Member of site development group with primary responsibility for quality recommendations regarding laboratory and factory 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.
- Provide regular updates and recommendations to VP of Technical Services regarding the status of quality objectives, projects, and goals.
- Hire, manage, and develop Quality Assurance staff and to support the company’s goals and objectives. Conduct employee performance evaluations; assist in setting goals and objectives in alignment with the overall company goals and objectives.
- BS in scientific discipline, graduate degree preferred
- Strong knowledge of CFR 111 is required.
- Minimum 7 years’ progressive responsibility in pharmaceutical or dietary supplement industry in a QA leadership role
- Excellent verbal and written communication skills
- Demonstrated ability to manage and develop quality staff
- Knowledge of statistical analysis is required
- Proficient in MS Office application
- Knowledge of Quality Management System is desirable
- BS in scientific discipline, graduate degree preferred
- Ability to see the big picture and manage the fine details
- Excellent written and verbal communication skills
- Strong interpersonal skills and the ability to work well with people at all levels of the organization, including leadership
- A collaborative, team oriented approach
- A competitive compensation & benefits package will be available to the ideal candidate.