Senior QC Analyst

Tolmar•Windsor, CO

19h•$47 - $50•Onsite

About The Position

Performs complex testing of raw materials, bulk intermediate and finished products, and stability samples, according to established regulatory protocols and procedures, in support of manufacturing.

Requirements

Advanced knowledge and application of government regulations for drugs or medical devices including GMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
Advanced knowledge in the use of USP, NF and other compendia.
Highly proficient use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.
Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
Effective written and oral communication skills.
Ability to interpret, understand and follow analytical procedures and calculations.
Demonstration of training and project leadership skills.
Ability to train analysts on complex methodology.
Expert knowledge in analytical testing of drug substances and formulations.
Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
Six or more years of experience in an analytical laboratory position using advanced techniques and demonstrated proficiency with complex testing.

Responsibilities

Expertise in performing analyses on a variety of samples using advanced preparation techniques and analysis methods. Expertise with basic and intermediate techniques and analysis methods.
Provide mentorship to QC analyst in all aspects of analyses performed within the QC chemistry laboratory including but not limited to documentation, procedures, and regulations.
Accountable for documenting all activities and maintaining records according to good documentation practices.
Accountable for proper use, care, maintenance, and troubleshooting of instrumentation.
Performs high-level method transfers. Guides the department in the evaluation and implementation of new technologies.
Provide detailed accounts of testing performed to investigators. Perform investigational testing as directed by a primary investigator.
Perform laboratory investigations with management assistance.
Make scientific recommendations to management/technical writers regarding QC procedures. Able to take recommendations and incorporate those recommendations into a document to ensure the appropriate changes are made.
Responsible for acting as a technical reviewer for document updates to ensure changes that are made are justified and scientifically sound.
Route documents in the electronic document control system to ensure document updates are routed promptly and correctly.
Act as a subject matter expert for the QC department.
Complete tasks on time and with minimal errors. Follow all procedures applicable to job functions to ensure high quality of work. Mentor others in the department to ensure department maintains high standards for quality of work.
Prioritize tasks and performs job duties with minimal guidance from management.
Contributes to a highly productive environment by avoiding distractions.
Responsible for ensuring that company and regulatory data integrity guidelines are consistently followed.
Participates in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings. Hazardous waste involvement may include but is not limited to making waste determinations, generation, transportation, satellite accumulation, storage and disposal of multiple types of waste streams, and container management and inspections. Respond to spills per company procedures. Maintain compliance to all Tolmar health and safety policies, as well as OSHA standards.
Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Exhibits a positive and understanding attitude at all times. Remembers to look at situations from all aspects. Assists co-workers with the completion of tasks. Able to identify areas of contention on the team and will work with QC management to correct.
Support adherence to department budget by identifying alternative cost-saving and compliant materials and equipment, where appropriate.
Represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results, if necessary. May provide technical expertise to determine root cause of 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. Appropriately resolves differences of opinion. Upon delegation may be responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors.
A leader in compliance. Lead implementation of change and escalates issues as necessary. Demonstrate leadership aptitude in technical functions.
Identify issues and possible solutions and escalates those issues and solutions 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.
Understand and process complex information and exercises sound judgment, considering the situation, the issues, the key players and the levels of authority involved. Propose courses of action that further the objectives, priorities, and vision of the organization; sees "big picture".
Perform additional duties as assigned.