QC Analyst II

Regulatory Jobs; Windsor (CO); Sur place; USD 103 155 000 - 106 020 000; Plein temps

Avantages offerts par ce poste

Benefits package

Hazardous waste training

Résumé du poste

Tolmar is seeking a QC Analyst II to join our chemistry laboratory in Colorado. You will perform analyses on raw materials, intermediates, and finished products using established regulatory methods, document results, and ensure data integrity in a fast-paced, high-throughput environment.

Responsibilities include training junior analysts, transferring methods, supporting investigations, and contributing to continuous improvement while adhering to cGMP, GLP, and ICH guidelines.

Qualifications

• Bachelor's degree in scientific discipline, preferably Chemistry or Biochemistry.
• Two or more years of experience in an analytical laboratory position.

Responsabilités

• Perform analyses on samples using intermediate preparation techniques and analysis methods.
• Train junior analysts in analysis methods and lab techniques.
• Document all activities and maintain records according to good documentation practices.
• Maintain and use analytical instrumentation properly.
• Perform intermediate method transfers.
• Provide detailed reports of testing and support investigations as needed.
• Make scientific recommendations to improve QC procedures.
• Complete tasks on time and maintain high quality of work.
• Support continuous improvement through new ideas and process enhancements.

Connaissances

Analytical thinking

Written and oral communication

Regulatory awareness

Team collaboration

Formation

Bachelor's degree in Chemistry or Biochemistry

Outils

HPLC

FTIR

GPC

GC

UV-Vis spectrophotometers

Description du poste

Core Hours: Tuesday - Saturday, 10:30 pm - 7:00 am

• Training Hours may vary

Purpose and Scope

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

• 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, Skills & Abilities

• 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.

Core Values

• The QC Analyst II is expected to operate within the framework of Tolmar's Core Values:
  • Center on People: We commit to support the well-being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise-wide mindset that lifts the whole organization.
  • Are Proactive & Agile: We embody a culture of engagement and action. With a hands‑on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
  • Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
  • Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk-taking that drives better ways of working.
  • Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Two or more years of experience in an analytical laboratory position.

Compensation and Benefits

• Pay: $36.00 - $37.00 per hour, depending on experience
• Shift Differential: 20% after training period
• 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. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Working Conditions

• 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.

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.