QC Lead Analyst

Cobioscience; Windsor (CO); On-site; USD 53,000 - 76,000; Full time

Benefits offered by this job

Benefits package

Job summary

Tolmar is seeking a QC Lead Analyst to guide a team of analysts through testing and release of products and materials. You will train staff, manage scheduling, ensure regulatory compliance, and act as a technical resource within the QC lab.

The role emphasizes leadership, problem-solving and adherence to cGMP in a fast-paced manufacturing environment. A Bachelor’s degree and extensive analytical experience are required.

Qualifications

• Bachelor's degree in Science; chemistry/biochemistry preferred.
• Six+ years in analytical lab; minimum two years GMP in pharma.
• Experience with regulatory compliance and quality systems.

Responsibilities

• Train, assist and schedule analysts in testing and release.
• Perform testing and release of tolmar products and materials.
• Provide scheduling support to optimize lab efficiency.
• Coordinate activities to meet sample analysis timelines.
• Serve as technical resource for testing processes and documentation.
• Ensure FDA and cGMP compliance across operations.
• Conduct investigations, CAPA and root cause analyses.
• Mentor department staff to uphold high quality standards.
• Participate in audits and regulatory trainings.

Skills

Analytical testing

HPLC

GPC

FTIR

Problem solving

Education

Bachelor’s degree in Science

Tools

HPLC

FTIR

GPC

GC

UV-Vis

Job description

Core Hours: Monday - Friday, 8:00 am - 5:00 pm

Purpose and Scope

The QC Lead Analyst will provide training, technical assistance and scheduling support for a team of analysts responsible for the testing and release of Tolmar products and raw materials in support of manufacturing timelines.

Essential Duties & Responsibilities

• Support QC supervisors in providing training, managing resource allocation and balancing workload for analysts.
• Perform testing and release of Tolmar products, raw materials, and stability samples.
• Provide scheduling support for the testing and release of Tolmar products, working with QC Management to optimize laboratory efficiency.
• Coordinate laboratory activities to assure customer needs are met in terms of sample analysis cycle time.
• Serve as a technical resource for products and testing processes.
• Support development or revision of procedures and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance.
• Perform lab investigations and root cause analyses. Identify and complete CAPA.
• Support Analysts in instrument troubleshooting processes.
• Provide technical expertise for document (protocols, reports, and procedures) authoring and review within the QC department. Upon delegation, may have the final authority for review and approval of such documents.
• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results and establish sample priorities for reports.
• Perform responsibilities under minimal supervision and support departmental management in all aspects of organizational functions.
• Mentor others in the department to ensure department maintains high standards for quality of work.
• Support adherence to department budget by identifying alternative cost‑saving and compliant materials and equipment, where appropriate.
• Participate in company and department meetings, third party audits, and regulatory audits.
• Assist management in new endeavors including efficiency efforts, organizational tasks, and non‑routine activities that require a higher level of scientific skills and regulatory expertise.
• Make scientific recommendations to management and other departments regarding Quality Control laboratory protocol.
• Participate in required monthly safety trainings and annual HAZ‑COM, RCRA and API handling trainings. Maintain compliance with all Tolmar health and safety policies, as well as OSHA standards.
• 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

• Expert knowledge in analytical testing of drug substances and formulations.
• Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in method validation, analytical troubleshooting, product investigation and instrument qualification.
• Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Mastery in the use of USP, NF and other compendia.
• Ability to solve complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Effective oral and written communication.
• Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV‑Vis spectrophotometers.

Core Values

The QC Lead Analyst 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 Science required, preferably in chemistry or biochemistry.
• Six or more years of experience in an analytical laboratory environment with at least two years in a pharmaceutical GMP setting.

Working Conditions

• Laboratory setting. Will be exposed to solvents, bio‑hazardous materials, hazardous waste, and pharmaceuticals. Standing for long periods up to 4 or more hours in a work day.
• 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.

Compensation and Benefits

• Pay: $47.00 per hour
• 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.

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.