Solventum · 3 months ago
Quality Assurance Coordinator (Onsite: Columbia, MO)
US, Missouri, Columbia
Full-time
Onsite
Entry Level
$54K/yr - $66K/yr
1+ years expSolventum is a new healthcare company focused on creating breakthrough solutions to improve lives and support healthcare professionals. The Quality Assurance Coordinator role involves ensuring compliance with regulatory standards, collaborating across functions to resolve quality issues, and supporting audit and inspection activities.
Medical Device
No H1B
Responsibilities
Reviewing and dispositioning of batch records, analytical reports, and microbiology reports to ensure compliance with FDA, GMP, and Solventum regulatory standards prior to product release
Acting independently on standard procedures and escalating non-routine issues using proper GMP documentation protocols
Collaborating across functions—quality engineering, production, supply chain, and management—to resolve quality issues and ensure timely corrections
Training department personnel according to assigned plans and performing mathematical calculations to validate test data against specifications
Investigating and documenting root causes of quality issues in partnership with quality assurance engineers
Serving as a liaison across internal and external stakeholders, responding to technical inquiries and coordinating cross-functional information exchange
Supporting audit and inspection activities, including Back Room coordination, Front Room documentation scribing, and QC checks
Qualification
Required
Associate's Degree/Technical Diploma or higher from an accredited institution AND one (1) year FDA regulated manufacturing environment experience in a private, public, government, and/or military environment
Preferred
Two (2) years FDA regulated manufacturing environment experience in a private, public, government, and/or military environment
Computer skills (Excel, Word, PowerPoint)
Experience in working with complex organization, cGMP knowledge of records and reporting
Excellent personal interaction skills
Excellent planning and decision skills
Ability to multi-task and meet required deadlines
Strong problem-solving skills
Detail orientation
Benefits
Medical
Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits
Company
Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. We never stop solving for you.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase