Astrix ยท 22 hours ago
QC Associate Scientist
Lake County, OH
Full-time
Onsite
Mid, Senior Level
$75K/yr - $80K/yr
5+ years expAstrix is a leading contract manufacturer and research organization for APIs, seeking a skilled QC Associate Scientist to support their GMP-regulated analytical laboratory. The role involves performing routine and non-routine analytical testing, method transfers, and investigations, while ensuring compliance with regulatory timelines and quality objectives.
ConsultingInformation Technology
Hiring Manager
Alyssa Hollick
Responsibilities
Perform routine HPLC and GC analyses in a GMP API analytical laboratory
Execute and support GMP analytical method transfers, including preparation of transfer protocols and final reports
Conduct additional analytical techniques as needed, including but not limited to: FTIR, IC, Karl Fischer (KF), XRD, NMR, DSC, TGA, particle size analysis, Titrations, UV-Vis spectroscopy, and optical rotation
Coordinate release testing for raw materials, intermediates, and active pharmaceutical ingredients (APIs)
Perform out-of-specification (OOS) investigations and support root cause analysis
Ensure timely and compliant generation of analytical data to meet project and regulatory timelines
Review analytical data for technical accuracy and adherence to good documentation practices
Maintain compliance with cGMP, GLP, and laboratory safety requirements
Collaborate effectively with Quality Assurance, Production, and Technical teams
Perform other duties as assigned
Qualification
Required
Bachelor's degree (B.S.) in Chemistry or related scientific discipline required
Minimum of 5 years of experience in a pharmaceutical analytical laboratory or equivalent combination of Strong hands-on experience with HPLC and GC instrumentation
Proficient with standard laboratory equipment (balances, pipettes, pH meters, etc.)
Solid understanding of analytical chemistry principles and laboratory safety practices
Demonstrated experience working in cGMP/GLP environments, including QC or stability testing
Experience interacting with Quality Assurance and regulatory documentation
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
H1B Sponsorship
Astrix 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
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
Company data provided by crunchbase