Formulation Lab Technician

Position Summary:
The Formulations Lab Supervisor is a hands-on leadership position responsible for the direct supervision of all laboratory personnel while actively participating in the day-to-day formulation. This position serves as a working leader within the laboratory, balancing supervisory responsibilities with direct involvement in laboratory operations. The successful candidate will be expected to lead from the lab floor, perform formulations and laboratory activities alongside the team, troubleshoot issues in real time, and provide technical guidance while maintaining overall responsibility for laboratory performance, safety, quality and personnel development. This position is responsible for all activities necessary to ensure the lab is functioning at optimal levels.

Duties & Responsibilities include but are not limited to:

Hands- On Laboratory and Formulations Activities

• Perform and oversee daily formulation and laboratory activities.
• Maintain adequate inventory of chemicals, reagents, and supplies.
• Support scale-up and transfer of formulations from laboratory quantities to manufacturing-scale production.
• Collect, document, review and interpret laboratory, and process data. Ensure all lab documentation is completed efficiently, including equipment and calibration logs.

Supervisory Responsibilities

• Supervise all lab activities, including the proper completion of all buffers, conjugations, test lines and control lines used in Chembio Diagnostic products.
• Assure that all lab staff can demonstrate a basic knowledge of Immunochemistry, and assure in-process review of batch records/witness formulation of product, in compliance with Departmental, Company and Government procedures and regulations.
• Monitor employee performance and administer company policies; insure all written procedures are followed by lab technicians.
• Establish proper training and coaching of all lab staff.
• Responsible for coordinating a schedule with the Production department.
• Managing work assignments and responsibilities.
• Correct anomalies related to quality and efficiency within the department.
• Review all batch records and log books for completion and accuracy in a timely manner.
• Responsible for updating all batch records to reflect current lab practice, and reporting deviations to established processes.
• Assist in validation protocols for all new lab equipment and procedures.
• Responsible for closing work orders and labor tickets in NetSuite in a timely manner.
• Maintain an accurate record of forward traceability for all inventory items.
• Assist QC in acceptance testing of incoming raw materials.
• Assist R&D in RIR investigations.
• Involvement with continuous improvement as it relates to the laboratory responsibilities.
• Insures compliance with regulatory standards, and adherence to all OSHA compliance laws and the requirements of the USDA and FDA.
• Insures departmental compliance with the requirements of cGMP.
• Represent the Formulations department at company meetings.
• Maintain lab cleanliness and organization.

Quality & Compliance

• Perform all laboratory activities in accordance with applicable GMP requirements, SOPs, safety procedures, and company quality standards.
• Ensure laboratory documentation is compliant with good documentation practices.
• Review laboratory notebooks, worksheets, formulation records, batch documentation, calculations, and other technical records.
• Support deviation, investigation, CAPA, change control, and non-conformance activities as required.
• Ensure proper identification, handling, storage, and disposal of raw materials, chemicals, samples, and laboratory waste.
• Maintain laboratory equipment in a clean, safe, and operational condition.
• Support internal, customer, and regulatory audits and inspections.
• Promote a culture of data integrity, quality, safety, and regulatory compliance.

Qualifications Required:

• Bachelor's degree in a life science or related field.
• Experience in the production of rapid diagnostic tests or equivalent.
• Experience with Microsoft Office applications, NetSuite is a plus.
• Management and Quality Systems coursework or training.
• Attention to detail and proficient record keeping.
• Excellent communication and time management skills