QC Analyst I (Onsite)

Tolmar Careers • Fort Collins, CO

21d • $28 - $29 • Onsite

About The Position

Purpose and Scope The Quality Control Analyst I is responsible for sampling, inspection, testing, and associated record keeping of samples. 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

• Basic understanding of a government-regulated laboratory environment, preferably for drugs and medical devices including GMP, GLP, and ICH and their application to laboratory testing and review processes and procedures.
• Basic understanding and familiarity in the use of USP, NF and other compendia.
• Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GC, and UV-Vis spectrophotometers.
• Ability to interpret, understand and follow analytical procedures and calculations.
• Working knowledge in drug or device cGMP.
• Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
• Ability to learn Tolmar’s electronic systems.
• Strong organizational skills and attention to detail.
• Skill in effective written and oral communication.
• Ability to work independently and properly prioritize tasks with limited supervision.
• Ability to work well with employees at all levels and departments.
• Ability to use critical thinking to address potential areas of concern.
• Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Ability to interpret, understand and follow analytical procedures and calculations.
• Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Valid driver’s license and Acceptable MVR may be required.
• Ability to bend, squat, and lift minimum of 30 pounds required.
• Ability to pass physical and eye exam required.
• Ability to see color.

Nice To Haves

• Previous experience in an analytical laboratory position preferred.
• Experience in a high-volume manufacturing environment preferred.

Responsibilities

• Complete training and become proficient in basic preparation techniques and analytical methods.
• Perform analyses on a variety of samples using basic preparation techniques and analytical methods.
• Inspect and sample materials in accordance with specified requirements.
• Determine appropriate sampling area and PPE requirements based on material properties.
• Perform heating, mixing and sampling of raw materials using laboratory and material handling equipment.
• Ensure proper status, containers, and storage of materials and product.
• Review SOPs and work instructions using the electronic document management system.
• Collect and retain samples in accordance with procedures.
• Perform retest sampling.
• Pull additional sample requests or inventory requisitions for items in inspection.
• Perform cleaning and monitoring of rooms and equipment.
• Document all activities and maintain records in adherence to good documentation practices.
• Maintain accountability for proper use and care of instrumentation.
• Complete tasks on time and work to eliminate repeat errors.
• Follow all procedures applicable to job functions to ensure high quality of work.
• Prioritize tasks and performs job duties with minimal guidance from management.
• Work to complete tasks in an efficient manner and serve as a productive member of the department.
• Contribute to a highly productive environment by avoiding distractions.
• Follow procedures to determine status or disposition, and properly document results on records and in laboratory notebooks.
• Ensure that company and regulatory data integrity guidelines are consistently followed.
• Provide detailed accounts of testing performed to investigators.
• Under the direct supervision of an investigator, may perform investigational testing.
• Maintain accountability for promoting an atmosphere of teamwork, cordiality and respect towards co-workers.
• 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 support 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.
• Interact respectfully with all other employees both inside and outside of the department and members of management and show interest in others’ input and reasoning.
• Appropriately resolve differences of opinion.
• Complete training in accordance with requirements and timelines.
• Coordinate equipment calibration with Calibration Technicians.
• Monitor equipment and facilities for proper operating conditions.
• Participate in monthly quality and safety walkthroughs.
• Perform various other 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees