QC Analyst II

• Training Hours may vary

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

• Perform analyses on a variety of samples using intermediate preparation techniques and analysis methods. Employee will be trained and become proficient in the intermediate preparation techniques and analysis methods.
• At the direction of management, train junior analysts in analysis methods and lab techniques.
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Accountable for proper use, care and maintenance of instrumentation.
• Perform intermediate method transfers.
• Provide detailed accounts of testing performed to investigators. Under the direct supervision of an investigator, may perform investigational testing.
• Make scientific recommendations to management/technical writers regarding QC procedures.
• Completes tasks on time and works to eliminate repeat errors. Follows all procedures applicable to job functions to ensure high quality of work.
• Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks in an efficient manner, and is a productive member of the department. Contributes to a highly productive environment by avoiding distractions.
• Employee is responsible for ensuring that company and regulatory data integrity guidelines are consistently followed.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Willing to assist co-workers in the completion of tasks.
• Will represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary.
• Interacts respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning. Appropriately resolves differences of opinion.
• Upon delegation, may be responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors.
• Identifies issues and escalates 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. Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform additional duties as assigned.

• 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.

• The QC Analyst…