TalentBurst, an Inc 5000 company · 2 days ago
Senior Analyst, Analytical Quality Control
Newark, CA
Full-time, Contract
Onsite
Senior LevelTalentBurst, an Inc 5000 company, is seeking a Senior Analyst in Analytical Quality Control. This role ensures the integrity and quality of drug substances and products through rigorous testing and compliance with cGMP standards.
Human ResourcesRecruitingStaffing Agency
Responsibilities
Performing and reviewing of chemical/bioanalytical tests, specifically HPLC (Cation Exchange, Size Exclusion, Reversed Phase) for raw materials, intermediates, and drug substance and drug products for release and stability programs
Accurately record, analyze, and report results, identifying any deviations from specifications and procedures
Write/review SOPs, protocols, assay worksheets, stability reports, and quality records such as laboratory investigations, deviations, CAPAs, and change controls
Ensure the laboratory is in cGMP compliance with regulations (e.g., FDA and CDC), pharmacopeia standards, and established procedures
Maintain laboratory space to regulatory expectations and internal procedures regularly, including support of equipment qualification and onsite vendor support
Conduct root cause analysis for quality issues and collaborate with cross-functional teams for resolutions
Manage lab supplies and samples
Ensure a safe and secure laboratory environment, providing training to junior analysts on laboratory procedures and assays
Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Analytical Development, to resolve quality issues and support process improvements
Qualification
Required
Experience in performing testing of raw materials, in-process samples, and finished goods using advanced laboratory techniques (e.g., ELISA, SDS-PAGE, Western Blot, HPLC)
Experience with HPLC (preferably with biologics)
Ability to accurately document results and investigate out-of-specification findings
Knowledge of cGMP standards and compliance with regulations (e.g., FDA and CDC)
Experience in writing/reviewing SOPs, protocols, assay worksheets, stability reports, and quality records
Ability to maintain laboratory space to regulatory expectations and internal procedures
Experience in conducting root cause analysis for quality issues
Ability to manage lab supplies and samples
Experience in ensuring a safe and secure laboratory environment
Ability to provide training to junior analysts on laboratory procedures and assays
Ability to collaborate with cross-functional teams, including Manufacturing, Quality Assurance, and Analytical Development
Company
TalentBurst, an Inc 5000 company
Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.
Founded in 2002
1001-5000 employees
H1B Sponsorship
TalentBurst, an Inc 5000 company 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 (3)
2023 (7)
2021 (1)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
Recent News
WBJournal.com
2026-02-07
2025-11-19
Seattle TechFlash
2025-04-17
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