Fladger Associates · 4 hours ago
Research Associate
Fremont, CA
Contract
Onsite
Mid, Senior Level
2+ years expFladger Associates is seeking a Sr. QC Associate for their lab in Fremont, CA. The role involves executing and coordinating analytical testing of drug substances and products in a regulated environment, along with routine quality and compliance activities.
Staffing & Recruiting
Hiring Manager
Sandra Gupta
Responsibilities
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 and Company 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 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
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
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
Preferred
Previous QC Experience preferred
Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
Company
Fladger Associates
Fladger Associates is a professional, national executive search and human capital solutions firm specializing in licensed, degreed, or certified professionals in: .
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase