Document Control Specialist Dietary Supplements at Danette May Mindful Health
Document Control Specialist Dietary Supplements
- Remote, CO
- Full Time
- Entry Level
Mindful Health is the company behind America’s Leading Healthy Lifestyle expert, Danette May. Danette May is also the founder of The Rise movement and the superfood company iRise Organics, and the author of the book The Rise: An Unforgettable Journey of Self-Love, Forgiveness, and Transformation (Hay House 2018). She is also the bestselling author of the books 7-Day Jumpstart, Whole You Healing Detox, and 150+ Fat Burning Recipes. Her programs include the online coaching and membership program Fit Rise; exercise DVDs, recipe books, online health and fitness challenges, and healthy lifestyle and mindfulness coaching. The Mindful Health brands focus on the three pillars of healing: healing foods, healing movement, and a healing mindset.
Mindful Health was named #48 on the Inc. 500 2018 list of the fastest-growing private companies in the US. Through our various entities, iRise Organics and FitRise, we strive to change the world via healing & organic foods, sustainable eco-friendly packaging, and a healthy approach to body movement and mindfulness. 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.
For more information on our Company and culture please visit www.danettemay.com/career
This is a US-based position and is fully remote.
The Document Control Specialist maintains the documentation control system for iRise Organics and reports to the Director of Quality.
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.
Description & Influence:
- Maintain and distribute procedures throughout iRise Organics 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 iRise 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 company grows.
- Potential for occasional site visit travel.
Background & Experience:
- Prior experience in the nutritional supplement industry.
- 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
- 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.
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