Senior Quality Control Specialist

Lansing, IL - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Senior Quality Control Specialist

Who we are

We are a team of scientists engineers technicians and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration curiosity and camaraderie thrive. We also enjoy darts cornhole ping-pong chili cook-offs and other fun events that makes our company a community where we make a life not just a living.

Who you are

You have a precise nature and embrace attention to detail. You value established procedures to ensure first-time quality for accurate and on-time results. Words that describe you are consistent efficient diligent and technologically savvy. You also embrace change to keep pace with emerging information and shifting priorities offering suggestions to improve process get great satisfaction in data integrity scientific rigor and adherence to cGMP requirements and you approach your work with accountability precision and integrity. You easily transition between working independently to working with a team with excellent customer service as your internal guide.

What you can expect to work on

The Senior Quality Control (QC) Specialist provides oversight to ensure the safe and effective testing of pharmaceutical products manufactured at Niowave Inc. This role is responsible for quality control oversight and direction for incoming material inspection and testing environmental monitoring sampling and testing product stability monitoring and testing and batch release testing. The Senior QC Specialist ensures that all projects and testing activities are completed in compliance with applicable regulatory requirements.

Monitor and maintain the QC state of inventory quality equipment maintenance calibration and facilities to ensure they comply with Quality Systems and cGMP requirements
Drive quality and compliance adhering to all Quality System documentation requirements and establishing/supporting plans to exceed Niowaves goals for quality safety compliance on-time delivery (OTD) and financial objectives
Lead new or revised validation of test methods monitoring processes and equipment as needed
Develop author and revise QC standard operating procedures work instructions test methods protocols and reports
Develop QC operational readiness plan and support hiring plan to implement a QC team to support multiple facilities
Initiate review and approve non-conforming material reports (NCMRs) investigate deviations investigate laboratory out-of-specification (OOS) and write and implement corrective and preventative action reports (CAPAs)

What you need to succeed

Bachelors degree or equivalent in science engineering or related field
8 years relevant experience in quality compliance or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
Experience operating in a cGxP environment with the ability to apply best practices
Experience implementing QC teams and operations with guidance from current operational excellence tools e.g. Six Sigma 6S and PDCA
Hands-on experience utilizing root cause analysis and continuous improvement systems
Substantive knowledge of applicable pharmaceutical regulations including working knowledge of Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Embraces and models the Niowave Core Values of Teamwork Courage Integrity and Upright Zeal
Understands how to integrate into a new team/organization appreciates the history of current state know how and when to make suggestions as well as using just the right pace to reach the improved future state
Understands your own communication and learning styles can assess others styles and is able to find the right path to best connect with colleagues

Great to have

Masters degree or equivalent in science engineering or related field
10 years relevant experience in quality compliance or manufacturing within a GMP pharmaceutical or radioisotope manufacturing setting
Experience with Minitab JMP or other analytical tools
Experience with ERP and/or LIMS systems
Experience in team status and reporting tools e.g. Project Smartsheet PowerBI etc.
Previous medium to large scale project management experience
Knowledge of the following regulations: ISOCFR 820 Nuclear Regulatory Commission (NRC)
Quality Certifications e.g. ASQ SSGB SSBB CQA CQE etc.

Please provide a cover letter specifically describing the nature of your background and experience as it relates to this position.

Required Experience:

Senior IC

Senior Quality Control SpecialistWho we areWe are a team of scientists engineers technicians and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration curiosity and camaraderie thrive. We als...