Kleen Test has an immediate opening for a self-motivated and driven Stability Program Leader for our Sunset facility in Port Washington, WI. The ideal candidate will have prior experience in a regulated environment with an understanding of product stability requirements (in particular, FDA and EU). The individual should have experience with Quality System documentation (i.e. reading/following/writing SOPs, writing protocols and reports. investigation writing).

Sign-on Bonus Details

$500 paid at 60 days, $1000 at 6 months. Must be in good standing to qualify. Bonus will be paid on the next full pay period once the milestone has been reached.

Essential Functions of the Stability Program Leader

• Lead the KTP Stability Program for drug and cosmetic products.
• Prepare Stability Protocols that meet regulatory (FDA & ICH) requirements and customer expectations.
• Ensure that required stability samples are collected from production, placed on stability under appropriate conditions, pulled at the required time, and promptly testing against protocol specifications.
• Coordinate and oversee outside storage and testing of samples when required.
• Review, summarize, and interpret stability data for inclusion in Stability Reports and Annual Product Reviews.
• Prepare final Stability Reports for review and approval.
• Leads and/or coordinates review meetings related to the KTP Stability Program.
• Monitor onsite stability chambers to ensure internal conditions meet regulatory requirements.
• Drive effort to establish a stand-alone KTP Stability Program as part of the strategic plan.
• Serve as a back-up for the Product Data Analyst in the preparation of Annual Product Reviews. Assist in cross training the Product Data Analyst in critical aspects of the KTP Stability Program.
• Perform other projects and assignments as requested by Management.

Requirements

• Requires a Bachelor’s degree, preferably in the natural sciences.
  
• Must have the ability to obtain advanced expertise in Minitab statistical analysis software.
• Prior experience (5 years) working in a cGMP compliant environment.
• Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations (especially FDA rules and Guidance Documents).
• Must possess the judgement and decision-making skills to respond promptly and appropriately to inquires or complaints from KTP customers, related to the Stability Program.
• Must have excellent communication skills (written and verbal) to prepare clear, concise Stability Protocols, Final Stability Reports, and other documents free of grammatical errors and ambiguous language. The ability to summarize findings and present to team members and all levels of management in a clear and concise manner is necessary.
• Strong project management, planning, and organization skills are essential requirements of the position.
• Requires the ability to work with and apply mathematical concepts such as probability and statistical inference, exponents, logarithms, quadratic equations, frequency distributions, determination of test reliability and validity, analysis of variance, and correlation techniques.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Can define the problem, collect data, establish facts, and reach a valid conclusion. Ability to interpret an extensive variety of technical instructions in oral, written, mathematical or diagram form.
• Demonstrated excellence in Microsoft Office (Word, Excel, Access, Power Point), Google suite, Minitab statistical analysis software, and the internet

Benefits

Culture

• Safety is KTP's top priority - everyone should go home in the same condition they came to work
• KTP builds collaborative relationships that strengthen the overall work environment
• Opportunity for growth, development and advancement within each department, or across departments
• Fast-paced environment, constantly changing, and the days go by quickly!

Benefits

• Comprehensive medical insurance plan and prescription drug coverage
• Comprehensive dental insurance plan
• FREE Basic Life and AD&D Insurance (company-funded & voluntary options)
• Short and Long Term Disability coverage (FREE company-funded coverage & voluntary options)
• Voluntary Life & Disability Program Eligibility
• Optional Flexible Spending Accounts (medical & dependent care)
• Prescription safety glasses cost-sharing program
• FREE financial wellness counseling and tools
• Time off for preventive care doctor appointments
• 401(k) retirement plan with employer match
• Employee Assistance Program (FREE to employees and your families)
• Paid vacation time (earn more as your seniority grows!)
• Company-paid holidays
• Nicotine-cessation aid reimbursement
• Continuing education opportunities/ Tuition Reimbursement program
• Onsite annual Health Risk Assessments
• Gym membership discounts (at participating locations)
• Community involvement & volunteer opportunities
• AT&T and Verizon wireless discounts

More info at - https://sites.google.com/kleentest.com/welcome/why-kt