Analyst (HPLC), Quality Control

Avid Bioservices

49d•$26 - $32•Onsite

About The Position

The Analyst (HPLC), Quality Control will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. This position requires a strong background in HPLC and supports/leads continuous improvement initiatives.

Requirements

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.
Strong written and verbal skills.
Exceptional multitasking skills and attention to detail.
Ability to build relationships with team members, clients, vendors, or suppliers.

Nice To Haves

A "bring it on!" team player approach and an unshakable positive attitude.
Ability to work overtime and/or weekends when necessary.

Responsibilities

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.