- Performs equipment, cleaning, and process validations for all new and existing OTC drug product processes and supporting systems.
- Performs validations in support of FDA guidelines as found in 21 CFR 210,211 and appropriate guidance documents.
- Set-up and maintenance of all internal Statistical Process Control (SPC) and Statistical Quality Control (SQC) systems for the measurement of internal systems.
- Provides expertise in statistical analysis as required.
- Works with R&D in new product development in the function of developing and implementing internal process specifications based on product design.
- Works with R&D, Engineering, and Production in pilot and scale-up activities for the smooth transition of new products produced internally.
- Works with Engineering in the documentation and qualification of the installation of new equipment, especially those related to the manufacture and distribution of OTC drug products.
- Coordinates the documentation and tracking of Q-studies within QA.
- Assists in internal audits, as needed.
- Performs other duties as assigned or needed.
- Destruction of outdated documents and retain samples according to guidelines.
- Bachelor's degree (or better) in an applied science (engineering and/or design preferred) or 4+ years industry Quality Assurance experience, preferably in a laboratory setting.
- A working knowledge of Federal Regulations regarding the manufacturing and distribution of drug products.
- Excellent mathematical and statistical skills especially related to SPC.
- Knowledge and experience in Total Quality Management concepts and practices.
- Excellent verbal and presentation skills.
- Ability to organize and coordinate projects.
- Ability to work well interdepartmentally.
- Ability to perform multiple tasks in a fast-paced setting with efficiency and accuracy.
- Self starter, task oriented.
- Computer word processing, spreadsheet, and database skills.
- Ability to climb stairs.
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IPQA Validation Specialist - Idaho Falls, United States - Melaleuca
Description
Company ProfileMelaleuca has firmly supported this mission statement since our humble beginning in 1985.Everything we accomplish is done with an eye toward promoting the physical, environmental, financial, and personal wellness of those around us.
Our focus has always been on wellness.By manufacturing and selling effective, high quality, natural, health oriented products we help people live more vibrant, healthier, and happier lives.
When you walk through the doors at Melaleuca, you can feel it immediately. This is The Wellness Company.We have achieved consistent and profitable growth with our annual revenue hitting over $2 billion dollars. We now have over 4,000 employees and operate in 19 countries around the world. Melaleuca is positioned to grow even more rapidly in upcoming years.
OverviewPerforms equipment, process, and cleaning validations per FDA requirements.
Acts as liaison between Quality Assurance, Production, Engineering, and Research and Development for the implementation of new processes and measurement of existing processes.
Coordinates the department/facility statistical analysis and Statistical Process Control activities. Works with R&D and Production in pilot and scale-up activities.Reasonable AccommodationEssential duties, responsibilities, and qualifications of the job can be performed with or without reasonable accommodation and without posing a direct threat to him/herself or others.
ResponsibilitiesEssentialAdditional
QualificationsEssential
Additional
We manufacture and distribute nutritional, pharmaceutical, personal care, facial care, home hygiene, and other wellness products and distribute them directly to the consumer through a full-service catalog and Internet shopping system.
We carefully craft products used every day with the highest standards of safety, health, and wellness in mind.This revolutionary system is changing the way hundreds of thousands of people shop by eliminating middlemen and reducing marketing and distribution costs.
This enables the company to spend more on research and high-quality, ecologically-sensible ingredients, while maintaining reasonable prices.Great culture - flexibility is a must in this position; you'll become a part of a fast-paced team dedicated to a feel-good lifestyle brand dedicated to changing lives.
Like the rest of Melaleuca, we are proud to be part of a values-driven organization that treats employees with respect.
Our employees and their families enjoy company parties and countless discounts around the community.We implement a very real open-door policy, and all employees are on a first name basis-it feels more like a family than a multi-national corporation.
Safe, uncrowded, affordable - nestled in the heart of beautiful Eastern Idaho, Idaho Falls is a prosperous and vibrant community, as well as the gateway to recreational paradise.
This unique setting provides numerous opportunities for total wellness social, physical, financial, and emotional.If you love outdoor activities, this is the place for you, with the Snake River running right through town, the Rocky Mountains dominating the horizon, and Yellowstone less than a 2-hour drive away.
Excellent compensation - in addition to a competitive wage, we offer comprehensive benefits for our full-time employees that include all you would expect plus some remarkable surprises, such as a longevity bonus.
The next step is yours. To apply today, click on the 'Apply' button.#J-18808-Ljbffr
