Quality Control Analyst

Primary Duties of a

Quality Control Analyst:

Execute routine in-process, drug substance, and stability test methods. Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Responsibilities of a

Quality Control Analyst:

Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP's). Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required. Maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations. Support low risk deviations, CAPA's and change controls within the electronic Quality Management System. Initiate and own laboratory investigations. Occasionally participate in department problem-solving. Author minor revisions to existing SOP's. Key Skills, Abilities, and Competencies of a

Quality Control Analyst:

QC Analytical Skill Set

• HPLC, UPLC, UV-Vis, Appearance, Concentration, pH, CE, Osmolality, TOC, strong micro pipetting skills QC Bioassay Skill Set
• ELISA's, Cell Maintenance, Cell-Based Assays, plate readers, Gels, icIEF, Aseptic Technique, strong micro pipetting skills, biosafety cabinets QC Micro Skill Set
• Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems Education and Experience Requirements of a

Quality Control Analyst:

Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework. 1-3 years of relevant experience. Previous experience in a regulated environment preferred. Laboratory instrumentation understanding or experience preferred. Knowledge of cGMP manufacturing preferred. Knowledge of basic chemical, biological and/or microbiological safety procedures preferred.

Pay:

$28.00 per hour

Education:

Bachelor's (Required)

Experience:

Analytical Quality Control:

1 year (Preferred) pharmaceutical lab: 1 year (Preferred)

Work Location:

In person