Full Job Description
Mindful Health comprises multiple companies that embody our three pillars of ultimate health and wellness: Healing Foods, Healing Movement, and a Healing Mindset. We believe that living in the fullest expression of yourself is the best way to impact the planet and the world, and every decision we make for each of our companies keeps this value in mind.
Our organization is made up of talented employees and contractors from all over the world who use their knowledge and skills to further the initiatives of the following three brands:
Danette May — Danette May is America's Leading Healthy Lifestyle Expert, the founder of The Rise movement, and the author of many books, notably The Rise: An Unforgettable Journey of Self-Love, Forgiveness, and Transformation (Hay House 2018). Her programs include online coaching in the areas of healthy lifestyle and mindfulness.
Fit Rise 365 — Our health and wellness online membership platform provides our community with fitness challenges, mindfulness exercises, and nutritional recipes that are intended to elevate overall health and wellbeing.
Earth Echo — Our superfood and supplement company offers the highest quality, most bioavailable products on the market. We believe we are made for more because when you feel good, you do good. As caretakers of the planet, we sustainably source only the best organic, non-GMO ingredients and deliver them to our customers so they can unleash their innate superpowers.
Mindful Health was named #48 on the Inc. 500 2018 list of the fastest-growing private companies in the US.
We seek individuals who are passionate about healthy living, are on a personal path of growth, and are committed to transforming the world around them in their own way. We believe that we are all individually empowered to change the world.
Our culture thrives on community, diversity, and inclusiveness. Individuals at Mindful Health are recognized for their contribution to the team, the culture, and the mission. It is our hope that every member of our team thrives and finds personal and professional fulfillment in their role.
The Document Control Specialist is a 100% remote position.
For more information on our Company and culture please visit www.danettemay.com/career
The Document Control Specialist maintains the documentation control system for Earth Echo and reports to the Director of Quality.
Description & Influence:
Maintain and distribute procedures throughout Earth Echo utilizing revision control and ensuring that all procedures are current and approved for use.
Utilize established change control methods when updating, approving, implementing and enforcing procedures.
Maintain and update relevant information for all raw materials and components utilized throughout the manufacturing process through direct contact with suppliers.
Create, update, and maintain active specification files for raw materials, components, and finished products.
Serve as a technical SME for the storage and organization of electronic documents on a G Suite server-based computer network.
Provide guidance and manage the updating, change control, and authoring of SOP's throughout Earth Echo Organics for compliance with State and Federal Regulations including cGMP requirements set by 21 CFR Part 110 and 21 CFR Part 111, NSF, Organic certifiers, and other regulatory bodies.
Control, maintain, and institute an active employee training program and provide basic cGMP training for compliance to cGMP requirements of 21 CFR Part 111.
Fulfill customer (internal and external) documentation request as needed. Responds to customer(consumers and wholesale customers) inquiries in a timely manner. Assist and coordinate in audit preparation, both written and on-sight.
Maintain a working document control system throughout the company.
Demonstrates competent technical writing skills.
Comprehend and link documents together.
Work independently with minimal supervision.
Perform multiple job duties as the company grows.
Potential for occasional site visit travel.
Review and approve labels
The focus of this job is on producing high quality, detailed work based on established standards, guidelines and procedures. Precise, consistent work output is essential requiring patience and a willingness to handle and complete one task at a time. The job environment is stable, based on known relationships with people and well-defined processes. Job knowledge and competency is built through structured step-by-step training and positive, supportive coaching from management and peers. Communication with others is based on knowledge of repetitive job routines and procedures gained from sucient on the job experience. Consistent, error free work based on dened regulations and standards are key measures of job performance success. The job environment promotes steady, methodical work output so that job routines can be completed on time and error-free.
Background & Experience:
High school diploma with three or more years' experience in document control preferred under 21CFR111 and 21CFR110.
Associates or Bachelor's degree in food science, biology, or chemistry degree preferred.
A minimum of two years' experience in document control preferred under 21CFR111 and 21CFR110.
Windows Office Suite competency, G Suite and Excel at a high level of competency (including file linking, dropdowns, charts and pivot tables).
Experience in QMAS (quality management systems)
Prior batching software experience a plus
Must possess strong communication and comprehension skills.
Attention to detail and highly organized.
Must possess strong analytical, numerical, and reasoning abilities.
Technical writing experience for SOPs.
Moderate to advanced computer skills within a Windows OS environment.
Experience within a cGMP and 21 CFR 111/110 environment desired.
May be required to wear protective gear, including dust masks, gloves, etc. in vendor warehouses and facilities during off-site audits.
May include written and on-sight vendor audits.
Keyword: remote, telecommute, dietary supplement, nutraceutical, food, quality assurance technician, quality control, pharmaceutical