QC Analyst II (Onsite)

Tolmar CareersFort Collins, CO
$36 - $37Onsite

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.
  • 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.

Benefits

  • Benefits summary: https://www.tolmar.com/careers/employee-benefits
  • Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.
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