Formulations Lab Supervisor

Job Title:

Formulations Lab Supervisor

Department:

Formulations Department

Reports To:

COO

Pay Classification:

Exempt

Position Summary:

The Formulations Lab Supervisor is responsible for the direct supervision of all formulation and processing of Antibody Reagents and Diluents in accordance with written procedures and specifications. This position assures all activities necessary to assure the lab is functioning at optimal levels, such as on time instrument calibrations/PMs, real time inventory transactions, cycle and scrap authorizations, as well as availability of materials/components for efficient operation.

Duties & Responsibilities include but are not limited to:
  • 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 and constructing a daily Formulations schedule.
  • Assign lab technicians’ daily work assignments and responsibilities.
  • Correct anomalies related to quality and efficiency within the department.
  • Ensure all lab documentation is completed efficiently, including equipment and calibration logs.
  • Review all batch records and paperwork 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.
  • Maintain adequate inventory of chemicals, reagents, and supplies.
  • Responsible for closing work orders and labor tickets in Visual 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.
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, Visual a plus.
  • Management and Quality Systems coursework or training.
  • Attention to detail and proficient record keeping.
  • Excellent communication and time management skills.

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.