Senior Chemistry Quality Lab Supervisor Job Listing at ICU Medical in Austin, TX (Job ID 24300277)

Description

FLSA Status: Exempt 

Position Summary:
The Senior Chemical Quality Supervisor oversees testing of raw material products (Active Pharmaceutical Ingredients (API), Excipients and Chemicals), in-process, and final products manufactured at the Austin site in support of manufacturing. The Sr. Supervisor is responsible for ensuring that all products and incoming materials conform to specifications and are in compliance with local and regulatory cGMP requirements.

Essential Duties & Responsibilities:
•Hire, supervise, and ensure training of all laboratory analysts in the performance of quality control tests in accordance with standard test methods and current regulatory requirements.  This includes qualitative and quantitative evaluation of solutions, drugs and commodities.
•Assure that all products received in the labs are logged, assigned to analysts for testing and reviewed for completeness and accuracy of testing as needed.  Assure that the results are compared to standard specification requirements, results are documented on the appropriate testing form and the form is reviewed, approved and properly filed.
•Review and release analyst testing results for conforming materials to the appropriate area.  If results are nonconforming, initiate the appropriate exception document, notify the appropriate personnel, and assist in correcting 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.
•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 and that the reagents are not expired.  Maintain an adequate inventory of laboratory supplies.
•Assure current specifications are available and properly utilized.  Make written recommendations for appropriate Product Specification and Standard Test Method revisions for improved testing methodology and specification limits.
•Review Collection and/or Sampling Plans, Batch Records, Controlled Documents to maintain compliance.
•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.
•Ensure lab operations are performed within budget.      
•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.
•Make decisions regarding capital equipment and laboratory expenditures in the laboratories.  Provide expertise to other areas purchasing laboratory type testing equipment.
•Interact with equipment manufacturers/vendors to ensure the lab instruments are properly maintained and repaired in a timely manner.  Ensure proper documentation of all maintenance activities.
•Interface with Corporate and site purchasing to resolve commodity problems with suppliers, and visit suppliers, as necessary, to assist in problem resolution and corrective action.
•Interface with suppliers to ensure compliance with specifications and to develop quality programs.  Trend data using SPC in order to achieve/maintain the highest quality level of commodities.
•Analyze commodity inspection data to identify trends.  Develop and implement programs to improve/enhance data collections, reporting, and evaluation for the purpose of improving commodity quality.
•Interview and make recommendations concerning new employee candidates.
•Make recommendations to the Manager regarding merit increases, perform performance evaluations and responsible for timely disciplinary action involving subordinates.

Knowledge, Skills & Qualifications:
•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. 
•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.
•Knowledge of physical and chemical laboratory techniques is essential, including methods development and technical problem solving.  
•Must also possess a thorough understanding of various laboratory instrumentation, including HPLC, AA, Gas Chromatography, Headspace analysis and IR, TOC analysis and UV/VIS Spectroscopy.
•The incumbent must have the human relation skills required to organize, develop and motivate people and obtain cooperation and support of other functions and higher levels of management.  
•Must possess a thorough understanding of documentation systems in health care manufacturing.
•Must have demonstrated proficiency in the use of Microsoft office Suite (Excel, Word, Power point).

Education and Experience: 
•Must be at least 18 years of age.
•Bachelor's Degree required; in Chemistry, BioChemistry, Chemical Engineering or relevant science field.
•Requires a minimum of 3 years' supervisory experience and 5 years' total experience in Laboratories.  Knowledge gained through practical experience in manufacturing, engineering, or quality preferred.
•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.

Physical Requirements and Work Environment: 
•Setting is in an office and laboratory environment.  
•Minimal lifting may potentially be required “up to 10 pounds (lbs)”.
•Typically requires travel less than 5% of the time.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.