Niowave, Inc. · 14 hours ago
Senior Quality Control Specialist
Lansing, MI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expNiowave, Inc. is a team of scientists and engineers dedicated to developing medical isotopes to treat cancer. The Senior Quality Control Specialist is responsible for overseeing the testing of pharmaceutical products, ensuring compliance with regulatory requirements, and driving quality and compliance within the organization.
ManufacturingPharmaceutical
Responsibilities
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 Niowave’s 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)
Qualification
Required
Bachelor's 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
Preferred
Master's 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: ISO 13485, 21CFR 820, Nuclear Regulatory Commission (NRC)
Quality Certifications, e.g. ASQ SSGB, SSBB, CQA, CQE, etc
Company
Niowave, Inc.
Niowave is advancing cancer treatment by producing Actinium-225 (Ac-225) with cutting edge linear accelerator technology and radiochemistry.
51-200 employees
H1B Sponsorship
Niowave, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$5.2MKey Investors
Michigan Economic Development Corporation
2023-04-11Grant· $0.5M
2021-12-14Series Unknown· $1.7M
2019-08-20Series Unknown· $3M
Leadership Team
Terry Grimm
Chief Executive Officer
Recent News
2025-12-20
Company data provided by crunchbase