Performs quality control testing, assay development, reagent validation, troubleshooting, investigations, and documentation in a biotech manufacturing environment. Responsibilities include incoming materials QC, in-process testing, final product release, reagent preparation, SOP and protocol drafting, equipment calibration monitoring, laboratory maintenance, and inventory coordination while following GMP, GDP, and approved procedures.
Gator Bio is a growing biotech company located in Palo Alto, CA. We develop, manufacture and market instruments, biosensors, reagents, and consumables used by life science research for biotherapeutic characterization, drug discovery, pharmaceutical and vaccine development. Our mission is to simplify and accelerate biological analysis for biotherapeutic research and development.
Gator Bio is looking for an entry level temporary to permanent Quality Control (QC) biochemist who will perform QC tasks, assay development, reagents validation, troubleshooting and documentation based on methodologies and approaches according to strict SOP.ESSENTIAL DUTIES AND RESPONSIBILITIES
- Performing QC testing and validation following written procedures using GMP compliance.
- Performing material incoming QC, in-process testing, and final product release.
- Preparing reagents, buffers, standards, samples, and controls according to approved procedures.
- Multitasking effectively and efficiently to ensure maximum and high-quality output.
- Maintaining cleanliness and orderliness of work area .
- Performing assay development task based on the project.
- Using good documentation practices (GDP) to record original data.
- Compliance with all on-going training requirements.
- Independently drafting QC protocols or SOP.
- Participating in the direction of QC analytical method troubleshooting and in investigations of OOS results.
- Coordinating laboratory maintenance activities, including the monitoring of supply inventories, logbooks, and equipment calibration status.
- Must be a team player with good communication skills and detail oriented.
- Other duties as assigned.
QUALIFICATIONS
- BS in biology, chemistry, biochemistry, or other related science.
- 0 - 2 years’ experience in the related IVD or biotech field.
- High level of integrity, flexible, action oriented.
- High attention to detail, excellent organizational skills, and ability to work on multiple projects.
- Ability for problem-solving and decision-making.
- Excellent interpersonal and verbal communications skills.
- Proficient in Microsoft Office Suite - Word, Excel, PowerPoint, etc.
POSITION REQUIREMENTS
- Ability to lift, push, pull, carry, and/or move up to 20 lbs.
- The ability to lift 30 lbs. chest high will be required.
- The role will require long periods of standing and sitting.
- The employee will be required to use hands for computer work and pipetting.
- Must pass a health screening.
- Required biosafety training upon hiring.
To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Gator Bio Palo Alto, California, USA Office
2454 Embarcadero Way, Palo Alto, CA, United States, 94303
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