Niowave, Inc. · 14 hours ago
Senior Quality Assurance Specialist
Lansing, MI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expNiowave, Inc. is a company dedicated to developing medical isotopes to treat and eradicate cancer. They are seeking a Senior Quality Assurance Specialist to lead quality and compliance efforts, guide teams on quality processes, and support training management for quality personnel.
ManufacturingPharmaceutical
Responsibilities
Lead or guide team on NCMR, Complaints and CAPA; lead and/or support Internal and External Audits
Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations and improve productivity
Participates in pre- and post-production reviews and approvals providing quality and regulatory support
Lead quality and compliance by complying with all Quality Systems documentation requirements and establishing/supporting plan(s) to meet/exceed Niowave goals for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives
Lead and develop team members to develop our best team. Ensure the growth of our positive business culture through behaviors that align with our values and leadership competencies
Support training management for quality and operations personnel
Acts as a customer liaison and processes customer quality complaints
Lead and manage quality involvement for the development of new products or sustaining products via validation methodologies such as TMV, equipment, process and product
Qualification
Required
Bachelor's degree or equivalent in STEM field
8+ years of relevant experience in the pharmaceutical industry with direct experience with compliance and quality systems
Knowledge of pharmaceutical quality requirements for launching and sustaining new products, such as Lifecycle Management, Quality by Design or Technology Transfer
Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities
Experience with and working knowledge of cGMP and GLP quality systems
Embraces and models the Niowave 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 connect the two
Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams
Preferred
Masters degree in STEM field
Quality or Regulatory certifications are preferred (e.g., CQE, CQA, CQM, RAC)
10+ years of relevant experience in the pharmaceutical industry with direct experience with compliance and quality systems
Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S)
Experience operating in a cGMP CDMO or Finished Drug environment
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
2023-04-13
Company data provided by crunchbase