Summary:

Provides direction, coordination, and training for chemists.  Responsible for insuring efficient disposition of materials or product.  Leads projects to improve existing procedures and processes.  Uses standard operating procedures and good manufacturing practices, responsible for conducting routine and non-routine analysis of incoming raw materials, work-in-process materials and/or matched kits and filled bottle reagents.  Supports general QA/QC responsibilities, such as reference lot qualification, control range assignment, stability testing and product troubleshooting.

Responsibilites:

Provides supervision to assigned Chemist I and II's and/or Lab Technicians.  Trains existing and new reports.  Conducts routine analysis of raw materials, intermediates and/or matched kits and filled bottle reagents according to approved SOPs.  Documents test results, problems and other relevant information.  Creates and updates SOPs as necessary.  Provides direction in troubleshooting analyses and designs experiments when necessary to resolve issues.  Manages small project teams on an as needed basis.  Assists Product Transfer in developing specifications and procedures for QC.  Participates in interdepartmental meetings.  Performs other responsibilities to support the needs of the department as assigned by Supervisor.  Acts independently to determine methods and procedures on new assignments.

Requirements:

Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 5-10 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.  Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.  Experience leading small teams.  Skilled at analyzing data and summarizing results.  Strong working knowledge of clinical analyzers.  Strong math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.  Strong troubleshooting skills.  Basic statistics skills including regression and correlation.  Strong laboratory skills including pipetting, safety, and hazardous chemical handling.  Strong understanding of cGMP and how it applies to the work environment.  High level of reading comprehension skills.  Ability to follow written and verbal directions with a high level of accuracy.  Must be able to write clear, understandable documentation.  High level of verbal communication skills.  Good working knowledge of MRP (QAD).  Manual dexterity, must be able to lift/move up to 20 pounds.  Intermediate word processing and spreadsheet software skills.  Strong organizational skills to be able to manage multiple tasks simultaneously.