Core Hours: Monday - Friday, 8:00 am - 5:00 pm Purpose and ScopeThe 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.
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.
