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Analyst (HPLC), Quality Control
Avid Bioservices
Tustin, USA
Full-time
Mid · 2+ years experience
Onsite
USD 26.73-34 hourly / hour
Discovered 1 weeks ago
HPLCCapillary ElectrophoresisGMPAseptic techniques
Free
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HPLCCapillary ElectrophoresisGMP
Key Skills for This Role
HPLCCapillary ElectrophoresisGMPAseptic techniques
Full Job Posting
- Perform and review routine assays for HPLC and CE (Capillary Electrophoresis) with strict adherence to written analytical test procedures.
- Perform aseptic sampling, visual inspection, gowning and working in clean room areas, 5S methodology.
- Review, revise and write test methods, standard operating procedures and perform trending analysis.
- In addition to performing QC testing, the Analyst may be designated as study lead for validation projects, investigations and method development projects.
- Other functions include, but are not limited to, writing study protocols and reports; training other analysts; working with other departments in developing, revising and implementing QC procedures and policies.
- Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.
- Participate in regulatory inspections to ensure laboratory is in compliance with current Good Manufacturing Practices.
- Demonstrate and provide evidence to FDA officials that the laboratory operations conform to code of federal regulation.
- Support continuous improvement initiatives by ensuring training relating to test methods, standard operating procedures, are up to date to comply with current good manufacturing practices.
- Utilize Instruments software to perform calculations to minimize errors and eliminate time allocation for manual calculations.
- Perform other duties as assigned.
- BS in chemistry or biology or related field plus 2-4 years industry experience in a QC or analytical lab, or equivalent combination of education/experience.
- Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.
- Must have strong HPLC, Analytical Biochemistry and Chemistry experience.
- Must also have experience with most if not all of the following: protein characterization, electrophoresis, chromatography (normal phase, reverse phase, size exclusion, ion exchange, etc), aseptic techniques, assay and validation/qualification.
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
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