Polaris Pharmaceuticals Inc. ยท 1 month ago
Quality Control Analyst III, Analytical
Vacaville, CA
Full-time
Onsite
Senior Level
$80K/yr - $90K/yr
5+ years expPolaris Pharmaceuticals, Inc. is a therapeutic protein drug manufacturer located in Vacaville, California. The Quality Control Analyst III is responsible for performing biochemical, physical, and chemical evaluations of samples in compliance with cGMP guidelines, ensuring the timely completion of assignments and maintaining laboratory standards.
Biotechnology
Hiring Manager
Rajinder Kaur
Responsibilities
Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines
Reviews test data for accuracy, data integrity, system suitability, and conformance against defined criteria/specifications
Provides technical support with troubleshooting of test methods, as needed
Identify and contribute to OOS/OOE/OOT investigations related to testing performed
Initiate and author deviation and laboratory investigations
Maintains the laboratory in an inspection-ready state
Develops and maintains proficiency in a broad range of trained test methods
Train analysts on test methods and procedures
Responsible for authoring Change Control records and leading the revision of written procedures as assigned
Holds self and others responsible to abide by department and company policies and practices
Adheres to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements
Manage reagent and equipment inventory for assigned areas of responsibilities
Responsible for sampling and testing of incoming raw materials
Qualification
Required
B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry)
Minimum of 5 years of relevant laboratory experience
Strong working knowledge of cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH
Ability to follow written instructions and to perform tasks with direct or minimal supervision
Works independently as well as in a team environment
Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel
Good written, verbal, and communication skills
Strong documentation skills
Develop skills in the operation and routine maintenance of various analytical instruments and computers
Ability to understand the operation of the equipment and gain knowledge of the equipment used for testing
Ability to use skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation
Must occasionally lift and/or move up to 25 pounds
Specific vision abilities include close vision, depth perception and ability to adjust focus
Preferred
Experience with Protein analytics
SDS-PAGE
Separations technology for HPLC
Chromatography Data Systems (CDS) software such as OpenLab
Subvisible particles testing (USP <788>)
Company
Polaris Pharmaceuticals Inc.
Polaris Pharmaceuticals, is a biopharmaceutical development and manufacturing organization (CDMO) specializing in biologics derived from microbial systems.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Hugh Yu
Chief Operating Officer
Company data provided by crunchbase