Compunnel Inc. · 1 day ago
Quality Control Analyst -- PATDC5721744
Fremont, CA
Contract
Onsite
Mid, Senior Level
$32/hr - $35/hr
4+ years expCompunnel Inc. is seeking a Sr. QC Associate for their QC Lab General. The role involves executing and coordinating analytical testing of bulk drug substances and drug products in a highly regulated environment, as well as maintaining routine quality and compliance activities.
Information Technology & Services
Hiring Manager
Parag Patel
Responsibilities
Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing
Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility
Execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable)
Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed
Coordinates and maintains routine activities
Responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs)
Performs duties under limited supervision and according to standard operating and QC procedures
Trains other associates and technicians on methods and processes
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment
Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance
Required to work according to given schedules and flexibility to adapt working schedule upon prior given notice
Strong focus on execution of non-routine analytical methods or processes
Performs testing and review within several different analytical technologies
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
Reviews and trends analytical data and compliance processes to identify out of trends
Authors routine compliance documents
Identifies process anomalies and areas for improvement for operations
Qualification
Required
High School Diploma with 6 years of experience in cGMP regulated industry or equivalent
Associate Degree with 4 years' experience in cGMP regulated industry or equivalent
Bachelor's Degree in a science or engineering related field with 2 or more years of experience in cGMP regulated industry or equivalent
Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
Ability to execute and coordinate analytical testing of bulk drug substance and drug product in a multi-product facility
Ability to execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable)
Ability to perform duties under limited supervision and according to standard operating and QC procedures
Ability to train other associates and technicians on methods and processes
Ability to work in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment
Ability to follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance
Ability to work according to given schedules and flexibility to adapt working schedule upon prior given notice
Strong focus on execution of non-routine analytical methods or processes
Ability to review and trend analytical data and compliance processes to identify out of trends
Ability to author routine compliance documents
Ability to identify process anomalies and areas for improvement for operations
Ability to execute independently with adequate training 3-5 analytical testing methods with different analytical principles under minimum oversight by qualified staff
Ability to manage and review fundamental tasks such as but not limited to buffer prep, TCU maintenance, and cleaning
Ability to identify and implement fundamental improvements to lab process compliance activities
Ability to document work according to cGMP and cGDP
Ability to adhere to established regulations and follow cGMP established by site
Ability to report abnormalities and deviations in a timely and accurate manner
Ability to adhere to safety standards and identify unsafe situations / habits and escalate appropriately
Ability to maintain and improve lab areas according to predefined standards (5s)
Ability to maintain own training within compliance and train other technicians and associates on operations upon completion of trainer qualification
Ability to conduct group trainings on compliance topics and scientific principles as needed
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
5001-10000 employees
H1B Sponsorship
Compunnel 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
2025 (2276)
2024 (1682)
2023 (1992)
2022 (2366)
2021 (2223)
2020 (2220)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase