Astrix · 23 hours ago
Sr. QC Associate
Fremont, CA
Full-time
Onsite
Mid, Senior Level
2+ years expAstrix is a global, research-driven pharmaceutical manufacturer focusing on treatment options for diseases and conditions with no satisfactory treatment option to date. They are seeking a Sr. Quality Control Associate to support analytical testing activities within a cGMP-regulated biopharmaceutical manufacturing environment. The role involves executing and coordinating analytical testing, maintaining QC documentation, and ensuring compliance with global regulatory requirements.
ConsultingInformation Technology
Responsibilities
This role is responsible for executing and coordinating analytical testing of bulk drug substance and drug product across multiple analytical platforms, including chromatography, potency/bioassays, microbiology, raw materials, cleaning validation, and packaging testing
The analyst will independently perform and review 3–5 analytical methods, ensure accurate documentation, and support data trending, investigations, and compliance activities
Responsibilities include authoring and maintaining QC documentation (SOPs, test methods, specifications, and reports), identifying process improvements, and ensuring adherence to global regulatory requirements (e.g., FDA, EMA)
Qualification
Required
High School Diploma with 6+ years, Associate Degree with 4+ years, or Bachelor's Degree in a science or engineering field with 2+ years of cGMP experience
Strong technical knowledge of analytical testing in biopharmaceutical manufacturing
Demonstrated ability to independently execute methods, review data, and ensure compliance
Preferred
Prior Quality Control experience
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
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