JOB SUMMARY
The Quality Control Analyst is responsible for performing multiple functions in Banyan’s Quality Control Laboratory and, when appropriate, other departments including Production and Product Development. His or her duties include developing and performing protein/antibody specific analytical & Bioanalytical assays, preparing documentation for regulatory submissions, reviews of processes & analytical methods with R&D and Service Labs, assisting QA in internal audits and assay validation processes, among other functions listed below. The Quality Control Analyst is accountable to the QC Manager to meet such goals.
ESSENTIAL OPERATIONAL FUNCTIONS
- With minimal supervision, develop and perform analytical techniques, i.e. HPLC (SEC, RP), Ion Chromatography and Spectra photometry, for determination of protein purity, stability, identity or other characteristics.
- With moderate supervision, ability in performing Bioanalytical assays i.e. ELISA, Western Blot and SDS-PAGE.
- Instrumentation Knowledge of HPLC,UV-VIS Spectrophotometer, Micro Plate Reader and Micro Plate Washer
- Working knowledge of FDA GLP and GMP regulations and guidelines, and maintaining documentation in accordance with those guidelines, as well as Banyan’s internal procedures
- Experience utilizing common statistical software e.g. Sigma Plot, Excel, Prism Etc.
- Participate in various tasks including method development and data system management
- Other duties as assigned by supervisor
- EDUCATION REQUIREMENTS AND/OR EXPERIENCE AND TECHNICAL SKILLS
- A bachelors degree in the life sciences with at least 4 years experience in analytical laboratory
- Familiar with working in an FDA regulated environment
- Strong interpersonal skills
- Familiar with Microsoft Windows environment (Word, Excel, Outlook and the internet).
- Technical Writing skills (analytical, life science terminology)
- Promote cooperation and teamwork within the group and the other departments
- Ability to multitask
- Proven success with protein analytical method development, specifically in chromatography, amongst others.
- Current state driver's license.
- Satisfy criminal background check and drug screening per state requirements
Banyan Biomarkers has partnered with FloridaWorks for professional recruiting. For more information, go to
http://employflorida.com and search for job order 9521522.
Tags: Analyst, Bioanalytical, Chromatography, Control, ELISA, HPLC, Ion, Phometry, Quality, R&D, More…SDS-PAGE, Spectra