MCS Associate, Quality Control - The Steely Group

The Associate Quality Control will support the QC analytical biochemistry team by performing testing HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CE (capillary electrophoresis), CEX (cation exchange), HILIC (hydrophilic interaction). This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

Under general supervision, this position is responsible for performing analytical testing and support in the HPLC/Capillary Electrophoresis (CE) group in Clinical Quality Control.

Responsibilities:

• Responsible for one or more of the following activities in QC: analytical testing, sample and data management and equipment maintenance.
• Perform routine laboratory procedures such as sample analysis, standard and solution preparation.
• Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data.
• Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.
• Support introduction of new methods/techniques into the lab.
• Perform basic assay and instrument troubleshooting.
• May identify, recommend and implement improvements related to routine job functions.
• Must learn and comply with safety guideline and basic cGMPs
• Must be flexible in working schedule as required
• Must be able to be on-call for CEMS as required

Basic Qualifications    

• Bachelor degree and 2 years of Quality Control, Quality Assurance OR related experience OR Associate degree and 6 years of Quality Control, Quality Assurance OR related experience OR High school diploma / GED and 8 years of Quality Control, Quality Assurance OR related experience

Preferred Qualifications

• Experience in HPLC and/or Capillary Electrophoresis techniques
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to organize work, handle multiple priorities and meet deadlines
• Strong written and oral communication skills
• Must be detail orientated
• Must be flexible and adaptable to changing priorities and requirements
• Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
• Demonstrate understanding of when and how to appropriately escalate