QC Analyst I (Onsite)

Company: Tolmar
Location: Fort Collins
Posted on: October 23, 2024

Job Description:

DescriptionShift: Tuesday - Saturday, 8:00 am - 5:00 pm
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.
Essential Duties & Responsibilities

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• 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.
  
  Knowledge, Skills & Abilities
  
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  • 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.
    
    Core Values
    
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    • The QC Analyst I is expected to operate within the framework of Tolmar's Core Values:
      
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      • Consistently operate with the highest standards of ethics and compliance.
        
      • Take ownership of your actions, success and setbacks.
        
      • Respect each other and understand that honest collaboration is at the heart of our company's success.
        
      • Go the extra mile to make things happen.
        
      • Be committed to all we do and the patients we serve.
        
        
        Education & Experience
        
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        • Bachelor's degree in scientific discipline, preferably in Chemistry or Biochemistry.
          
        • Previous experience in an analytical laboratory position preferred.
          
        • Experience in a high-volume manufacturing environment preferred.
          
          Additional Requirements
          
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          • 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.
            
            Compensation and Benefits
            
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            • Pay: $28.60 - $29.10 per hour, depending on experience
              
            • Benefits summary:
              
              Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
              Working Conditions
              
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              • Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
                
              • Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
                
              • Business demands may present a need to work extended hours.
                
              • Working conditions are in an office, warehouse, laboratory and manufacturing environment.
                
              • Occasional overtime may be required.
                
              • Work may consist of travel between multiple facilities.
                
                Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.Qualifications
                EducationBachelors of Chemistry (required)
                
                Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Tolmar, Aurora , QC Analyst I (Onsite), Professions , Fort Collins, Colorado