IP QA Sr. Chemist

Overview

Management of Stability / Shelf-Life program including tracking of studies, statistical manipulation of data, generation of reports, etc.

Perform accurate and timely analysis of stability samples, chemicals / ingredients, bulk batches, finished goods, homogeneity samples, cleaning samples, and pre-market R&D samples according to current analytical procedures, SOP's and guidelines.

Perform laboratory equipment calibration and preventative maintenance.

Essential 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.

Responsibilities

Manage Stability Program : Set up files for new stability studies on computerEnter batch record information and manage data.

Review, validate and merge data entered.Prepare data for annual reports and write summary.Track and schedule Annual Stability Lots.

Track completed stability study samples to be discarded.Prepare stability reports for expiration date extensions, special studies and completed accelerated studies.

Review temperature charts and write deviations as needed.Maintenance and upkeep of environmental chambers

• Keeps all laboratory records tracked, traced, and maintained (i.e., SOP’s, policies, specifications, forms, testing record, etc.).
• Keeps current on all cGMP, USP / NF, FDA and ICH guidelines for drug manufacturing, stability testing, etc.
• GC, HPLC, and AA analysis of chemicals / ingredients, bulk batches, finished goods, homogeneity samples, cleaning samples, and pre-market R&D samples.
• Method development for new active ingredient testing and for evaluation of new products.
• Pre-runs approval of job packets.
• Interacts with all departments involved in testing, approval, release, etc. of all products, ingredients, and components.
• Responsible for moving all records to future formats (i.e., electronic paperless format).

Additional

• Performs other duties as assigned or needed.
• Destruction or storage of outdated documents according to guidelines.

Qualifications

Manage Stability Program : Set up files for new stability studies on computerEnter batch record information and manage data.

Review, validate and merge data entered.Prepare data for annual reports and write summary.Track and schedule Annual Stability Lots.

Track completed stability study samples to be discarded.Prepare stability reports for expiration date extensions, special studies and completed accelerated studies.

Review temperature charts and write deviations as needed.Maintenance and upkeep of environmental chambers

• Keeps all laboratory records tracked, traced, and maintained (i.e., SOP’s, policies, specifications, forms, testing record, etc.).
• Keeps current on all cGMP, USP / NF, FDA and ICH guidelines for drug manufacturing, stability testing, etc.
• GC, HPLC, and AA analysis of chemicals / ingredients, bulk batches, finished goods, homogeneity samples, cleaning samples, and pre-market R&D samples.
• Method development for new active ingredient testing and for evaluation of new products.
• Pre-runs approval of job packets.
• Interacts with all departments involved in testing, approval, release, etc. of all products, ingredients, and components.
• Responsible for moving all records to future formats (i.e., electronic paperless format).

Additional

• Performs other duties as assigned or needed.
• Destruction or storage of outdated documents according to guidelines.

Why Melaleuca

Melaleuca is one of the leading Health and Wellness companies in the world. 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 compen sation - 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