Chemical Quality Supervisor

Otsuka ICU Medical•Austin, TX

3d•Onsite

About The Position

Under the direction of the Manager, the CQ Supervisor oversees testing of raw materials, in-process, and final products manufactured at the Austin site. Assures products meet established specifications and that adequate substantiating data is maintained. Approves materials conforming to specification and resolves nonconformance issues. Assigned to one or more of the following laboratories: Final Product/Raw material/Resin Blending Chemical Laboratory or the In-process Chemical Laboratory.

Requirements

A thorough working knowledge of GLP (Good Laboratory Practice), GDP (Good Documentation Practice) and GMP (Good Manufacturing Practices) is required including experience with regulatory agencies including the FDA.
The incumbent must have skills required to organize, develop and motivate the people in his/her area of responsibility, as well as to obtain the cooperation of other functions necessary to fulfill assigned responsibilities.
Bachelor’s degree in Chemistry, BioChemistry, or Chemical Engineering.
A minimum of 2 years’ experience in a regulated industry (drug/device and FDA preferred), with Quality Control experience required.
Prior experience in analytical chemical laboratory methodology is required, including methods development, instrumental analysis and technical problem solving and Data Integrity, preferably in the Pharmaceutical industry.
Specific instrumental experience desirable will include: IR & UV Spectroscopy, Gas and Liquid Chromatography, Atomic Absorption and Polarimetry.
Must be at least 18 years of age

Nice To Haves

A minimum of 2 years’ experience in supervisory/leadership position is preferred.

Responsibilities

Supervise and train laboratory analysts in the performance of chemical quality control tests in accordance with standard test methods. This includes qualitative and quantitative evaluation of solutions, drugs and commodities.
Assure that all products received in the laboratories are logged in, assigned to analysts for testing, reviewed for completeness and accuracy of testing, results compared to standard specification requirements, results documented on the appropriate testing form, form reviewed, signed off and filed.
Review testing results and release conforming materials to Production. If results are non-conforming, advise the Manager, Manufacturing Quality Supervisor, and the Production Supervisor and assist in resolving the nonconformance.
Conduct investigations into process excursions, procedural exceptions and nonconforming events. Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations. Provide recommendations for action based on procedural requirements, decision flowcharts, and critical thinking.
Interview and make recommendations concerning new employee candidates.
Maintain an adequate record of all tests performed in the testing areas. This includes maintaining a Product Quality History record on all list numbers.
Maintain an adequate stock of reagents, test solutions and standard solutions used in testing and assaying product; assure that the test solutions preparation logbooks are properly maintained.
Make recommendations to the Manager regarding merit increases, perform performance evaluations and responsible for timely disciplinary action involving subordinates.
Assure that all equipment and instrumentation is properly maintained and calibrated in accordance with established procedures.
Assure that current specifications are available and properly utilized; make written recommendations for appropriate Product Specifications and Standard Test Methods revisions involving either minor procedural changes or major revisions for improved testing methodology and specification limits.
Initiate and be responsible for cost savings projects involving both material and labor utilization.
Make recommendations for capital equipment and laboratory equipment expenditures.
Maintain an adequate inventory of chemical and glassware laboratory supplies; initiate the purchase requisitions for needed supplies
Maintain cooperative working relationships with other departments.
Maintain current knowledge of all laboratory equipment (Liquid Chromatograph, Gas Chromatograph, Infrared, Flame Photometer, Atomic Absorption, Polarimeter, UV/Visible Spectrophotometer, etc.).
Ensure safety awareness by each of the lab employees and participate in the establishment of safety rules and instructions in the proper use of safety equipment.
Perform other related duties as assigned or required.