VARITE INC · 22 hours ago
Sr. QC Lab Associate
Fremont, CA
Full-time
Onsite
Mid, Senior Level
$32.97/hr - $35.32/hr
4+ years expVARITE is a global, research-driven pharmaceutical company focused on developing innovative medicines. They are seeking a Sr. QC Lab Associate to perform analytical testing and ensure compliance in a highly regulated environment, while also training other associates and maintaining routine quality activities.
Information Technology & Services
No H1B
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 Company's 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
Manufacturing Cell Culture, Manufacturing Purification, Engineering & Technology, Quality Assurance, Quality Control, Quality Systems, Analytical Science
Qualification
Required
Strong technical knowledge in analytical methods
Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues
Coordinates work within the team and cross functionally
Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place
Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions
Trains other associates and technicians on methods and compliance
This role provides necessary planning, interpretation, determination of acceptability of data to the FDA, EMA and / or clients
This role has high impact on site performance in terms of compliance
Previous QC Experience preferred
Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the First-Time
Proven experience with technical review, analysis and interpretation of scientific data Strong written and verbal communication skills
Experience with computer-based systems and experience with process control systems
Previous experience to read and understand SOPs and/or methods and document work in a written format applying cGMP/GDP standards
Ability to work as part of a high performing team and collaborate effectively with staff
High School Diploma with 6 years of experience in cGMP regulated industry or equivalent
Associate Degree with 4 years' experience of 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
Company
VARITE INC
VARITE has a definite spirit.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Adarsh Katyal
President & CEO
Sue Patel Arora
Vice President Of Strategic Partnerships
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