Niowave, Inc. · 4 hours ago
Quality Assurance Specialist I
Lansing, MI
Full-time
Onsite
Entry Level
1+ years expNiowave Inc. is a company dedicated to developing medical isotopes to treat and eradicate cancer. The Quality Assurance Specialist I will support key quality system activities to ensure products are manufactured in compliance with cGMP and regulatory requirements, collaborating with various teams to maintain high standards of safety and quality.
ManufacturingPharmaceutical
Responsibilities
Support configuration and training end-users on the electronic Quality System NCMRs, Complaints, OOS, Change Control, and CAPAs under guidance from senior team members
Support data collection and author basic investigations with minimal guidance
Assist with internal and external audits by preparing records, gathering evidence, and participating as needed
Follow all Quality Systems requirements and support initiatives that contribute to Safety, Compliance, Quality, On-Time Delivery (OTD), and continuous improvement goals
Support training activities for quality and operations personnel by maintaining training records and assisting with scheduling
Serve as a point of contact for internal Quality System questions
Contribute to quality for new or existing products through activities such as data collection, document drafting, test method execution support, or basic validation support (e.g., TMV, configuration acceptance testing, software, equipment, process, or product)
Compile metrics for quality monitoring and management review
Qualification
Required
Bachelor's degree or equivalent in science, engineering, or related field
1+ years' related experience or equivalent internship experience, with an understanding of regulatory compliance related to operations and quality procedures
Basic understanding of pharmaceutical quality requirements, cGMP/GLP, and general regulatory expectations
Moderate proficiency in Microsoft Word (styles, table of contents, section breaks, formatting tools)
Familiarity with PDF editing and publishing tools (Adobe Acrobat Pro)
Preferred
2+ years' related work experience
Quality or Regulatory certifications (CQE, CQA, CQM, RAC) or willingness to pursue them
Experience with lean manufacturing or continuous improvement tools (Six Sigma, Lean, 5S)
Experience configuring and maintaining an electronic quality system
Experience in a cGMP CDMO, API or Finished Drug environment
Experience in a facility with radiation regulatory requirements and/or quality role in the pharmaceutical or medical device industry
Experience in audits (internal, NRC, FDA, etc.)
Knowledge of the following regulations: ISO 13485, 21CFR 820, 21CFR 210/211, Nuclear Regulatory Commission (NRC)
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