QC Lead Analyst

Core

Hours:

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

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.

• 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.

• 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.

The QC Lead Analyst is expected to operate within the framework of Tolmar’s Core Values:

• Center on People: We commit to support the…