Chemist

SUMMARY

Responsible for Calibration manufacturing and testing. In addition, this position supports the transfer of new technology from R&D to Manufacturing.

• Adopts a "quality in everything we do" approach to all aspects of the execution of responsibilities of this position.
• Through vigilance, remains alert to any potential compliance situation and reports such observations to supervisors.
• With regard to this position, the Production Chemist II is trained on all Quality System Work Instructions (Wls) and follows them when performing their job functions.
• Responsibilities also include support of the calibration, operation and maintenance of any related production equipment when necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform calibration testing which includes running Total Hb, A1c whole blood Calibration, Temperature calibration, Accuracy bias, Initial lot release for Pilots / ICA and finished products and analyze the data accordingly.
• Assist in Stability testing and processing the meters as needed.
• Preparation of Whole blood samples for In house testing as needed.
• Take lead in tracking the performance of the lots (metrics).
• Develop and revise procedures. Train new chemists and drive assigned projects as needed. Make detailed observations, analyzes data and interprets results.
• Maintains production materials in working order and use calibrated equipment at all times.
• Regularly interact with R&D and identify process improvement opportunities in calibration. Ensure smooth transfer of new and improved processes to reagent manufacturing.

May support other functions as necessary.

• Acts as a resource for other production personnel. Interact and cooperate with other chemists within the department and throughout the corporation in a professional manner.
• Assists with inventory management for the department.
• Maintains good laboratory procedures and practices, as well as ISO and OSR (GMP) requirements. Adhere to all Safety Procedures as defined by CalOSHA and Site Safety policies especially those involving Chemical Hygiene, Hazard Communication and Blood borne Pathogens.

Ensure good housing keeping, and safe and organized work environment.

Daily use of various computer programs including, but not limited to, MS Word and MS Excel.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands to touch, manipulate, handle, or feel production items or materials repetitively.

The employee frequently is required to stand and sit for extended periods of time. The employee is occasionally required to reach with hands and arms.

Specific vision abilities required by this job include close vision.

QUALIFICATIONS

• Ability to use Chemistry and biochemistry / biology laboratory techniques.
• Ability to follow written and verbal instructions & time management skills.
• This position may require irregular and extended hours of work, so the person hired must be capable of meeting the varied work hours
• Prepare technical reports, summaries, and protocols and perform quantitative analyses.
• Methods for statistical experimental design and data analysis.
• Working well in a team situation with others, scientific and nonscientific is necessary on carrying out project team membership.
19 days ago