SUMMARY OF POSITION:
Analyzes process samples as received and performs non-routine analysis as requested. Analyzes raw material, in-process, finished goods, customer complaint, and stability samples by chemical, physical, and instrumental means as needed. Work with the Laboratory Manger to develop and validate new and existing methods for product analysis. Troubleshoot analytical instrumentation for errors or analytical anomalies. Interpret analytical data to drive to root causes and solutions.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Inspects raw materials, finished goods, and work-in-process to ensure that product complies with manufacturing specifications, releases products to the warehouse and/or appropriate department.
- Key player in the Cardinal Health Product Stability Program, works to analyze Patient Monitoring and Recovery services products and aid lab manager in developing protocols and analytical methods associated with their analysis.
- Documents inspections, test results, and raw data through the use of the laboratory information management system (LIMS).
- Investigates customer complaints and analyzes returned goods to determine cause(s) of failures, characterization of contaminations, reports findings regarding disposition, and assists in reducing manufacturing defects.
- Assist with and the development of analytical tests methods and associated validations.
- Performs analysis and assays via thorough understanding of laboratory standard operating procedures and instrumentation such as Gas Chromatography, Liquid Chromatography, Inductively Coupled Plasma-Optical Emission Spectroscopy, Flame Atomic Absorbance Spectroscopy, Fourier Transformed Infrared Spectroscopy, UV-VIS Spectroscopy, acid-base titrations, redox-titrations, Karl Fischer, and scales.
- Assist in any non-routine analytical work needed to solve plant quality problems.
- Aids in performing any non-routine quality control related tasks such as re-sampling, raw material testing. And performing analysis needed to validate methods and equipment.
- Assists in providing laboratory with an audit ready status as compared to global regulatory agencies as applicable.
- Works in a team environment to support internal and external customer requirements.
- Follow all ISO/EN/FDA, CMDR, JGMP, OSHA, ANSI and MDD Quality System requirements as well as other plant policies and procedures.
- Other duties as required, with or without accommodation.
- Environmental, Health and Safety (EHS) is a major cornerstone of this Company’s beliefs. Working safely and protecting the environment are an essential part of an employee’s job performance and all employees are responsible for adhering to plant EHS policies/procedures, report hazardous conditions or risks follow department EHS rules, PPE requirements, Good Manufacturing Practices (GMP’s), ISO 13485 regulations and Good Housekeeping procedures. All employees shall operate in a manner that protects the health and safety of its employees/visitors and operate in a manner that conserves energy, natural resources and protects the environment. In addition, all safety related incidents, no matter how slight, must be reported immediately.
- Initiate non-conforming product reports; and assist with NCR closures
- Conduct special testing for product analysis for internal/external entities
- Perform sensitive wet chemistry sample preparations
- Coordinate work schedules and coverage for weekends and absenteeism
- Write and Assist in Method development and Validations
- Work with quality technicians to communicate results and disposition products
- Conduct analysis involving product stability
- Troubleshoot mechanical problems with analytical instrumentation
- Other duties as assigned with or without accommodation.
- B.S. in a Science (Technology, Engineering, Mathematics related field, Chemistry /Biology, strongly preferred
- 1+ year related experience in a quality lab setting, preferred
- Knowledge of ISO/EN/FDA, CMDR, JGMP and MDD Quality System requirements, preferred
- Understanding of Basic Mathematics and complex chemical equations and reactions
- Ability to compute rate, ratio and percent and to draw and interpret graphs.
- Ability to read and interpret quality system documents and regulations
- Ability to write routine reports and correspondence. Ability to effectively present information in one-on-one and small group situations.
- Microsoft Word, Excel, PowerPoint, Visio, Quality Windows, BPCS ERP, LIMS
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.