QC Analyst II (Onsite)

Tolmar•Windsor, CO

8h•$36 - $37•Onsite

About The Position

Performs routine testing of raw materials, cleaning samples, bulk intermediate and finished product, and/or stability samples, according to established regulatory protocols and procedures.

Requirements

Knowledge of a government regulated laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
Intermediate understanding of the use of USP, NF and other compendia.
Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.
Effective written and oral communication skills.
Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
Ability to interpret, understand and follow analytical procedures/calculations and scientific principles.
Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
Two or more years of experience in an analytical laboratory position.

Responsibilities

Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods.
Train junior analysts in analysis methods and lab techniques.
Document all activities and maintain records according to good documentation practices.
Proper use, care and maintenance of instrumentation.
Perform intermediate method transfers.
Provide detailed accounts of testing performed to investigators.
Make scientific recommendations to management/technical writers regarding QC procedures.
Completes tasks on time and works to eliminate repeat errors.
Prioritizes tasks and performs job duties with minimal guidance from management.
Ensure that company and regulatory data integrity guidelines are consistently followed.
Maintain an atmosphere of teamwork, cordiality and respect towards co-workers.
Represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results.
Interact respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning.
Represent the QC chemistry laboratory when communicating with outside departments and vendors.
Identify issues and escalate those issues to the department senior leadership or management as appropriate.
Provide support to the department leadership with the implementation of new systems, and continuous improvement efforts.
Generate new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements.
Participate in required annual hazardous waste training.
Respond to spills per the Chemical Spill Procedures.
Perform additional duties as assigned.