Sr. Coordinator, Stability

POSITION SUMMARY STATEMENT:

 

The Sr. Stability Coordinator is responsible for implementing and leading the corporate stability process for Dietary Supplement, Food and Personal Care Products. The Sr. Coordinator will review and edit stability protocols and stability reports and organize corporate stability data. This role will review stability requirements, review internal protocols designed to test the stability of Herbalife products, review analytical data generated during stability studies, and review internal reports that detail the stability evaluation and compliance of Herbalife formulas.

 

DETAILED RESPONSIBILITIES/DUTIES: 

 

• Generate stability protocols and reports, data review and trend evaluation, and address compliance challenges related to stability.
• Evaluate the QC test methods and acceptance criteria used in all stability testing and recommend changes where appropriate.
• Interface with Quality, R&D, and Licensing partners to understand specifications and how to interpret results.
• Identify key formatting requirements. ensuring accurate content, cross-checking with interdisciplinary teams to ensure compliance, and following up with development partners to understand how to deal with non-compliant issues that are encountered.
• Analyze existing data to generate reports in a manner consistent with Herbalife standards.
• Collaborate with Stability Manager in creating stability reports using pre-defined templates and pre-existing data.
• Confer with interdisciplinary team to understand how to deal with products that don’t adhere to specification limits and proactively work to resolve these issues.
• When required, work with partners in Quality to get additional samples and/or perform follow-up testing to validate questionable results.
• Participate in the biweekly stability protocol review meetings.
• Coordinate with Herbalife’s contract manufacturers to acquire products for stability studies.
• Interpret data to determine if further testing is required.
• Ensure that the samples are analyzed, and the data is reported in a timely manner.
• Assist in audit and compliance program to meet ISO17025 laboratory accreditation requirements, including statistical analysis of data.
• Perform additional duties as assigned

 

SUPERVISORY RESPONSIBILITIES:

 

None

 

REQUIRED QUALIFICATIONS:

 

Skills:

 

• Solid knowledge of cGMP and GDP
• Ability to solve complex technical problems
• Strong analytical and problem-solving ability
• Able to interface with individuals from licensing, quality, and development backgrounds
• Skilled at managing multiple simultaneous projects
• Good verbal and written communication skills (technical writing and presentation)
• Microsoft Office Proficiency
• High attention to detail

 

Experience:

 

• 4 years of analytical experience in a laboratory or research setting, working specifically with dietary supplements, including familiarity with testing and specifications requirements and experience with HPLC, GC, MS and ICP.
• Technical writing experience (SOP, Regulatory submissions, technical reports)
• Sound understanding of ICH guidelines for stability testing of food and dietary supplement products
• Familiarity with statistical analyses related to food and supplement product stability including statistical software programs and stability software modules

 

Education:

 

• Bachelor of Science Degree in Chemistry, Biochemistry or related scientific fields

 

PREFERRED QUALIFICATIONS:

 

• Agile PLM (Product Lifecycle Management)/PQM (Product Quality Management)
• Previous work history involving stability studies at a food, supplement, pharmaceutical, or cosmetic company

Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP). Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.