SUMMARY: Performs enzyme activity assays and other advanced chemical analysis of samples submitted to SORA Laboratories. Performs routine testing, develops testing methods for samples, and calibration & maintenance procedures for analytical instrumentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following. Management retains the right to add to or change the duties of the position at any time. The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.
- Perform and report the assigned testing of samples submitted to the laboratory.
- Perform advanced chemistry instrumentation operation, maintenance and calibrations programs including HPLC, GC, FTIR, ICP or other equipment as assigned.
- Plan, coordinate and conduct in vitro testing research as contracted by SORA customers. Prepare reports as required.
- Perform, develop, validate, and improve testing methodologies and assist in testing customer specific methods.
- Review and improve method modifications for improved peak separation.
- Perform testing in support of OOS investigations.
- Record and peer-review analytical and calibration work performed as required for GMP and laboratory accountability.
- Maintain the laboratory record-keeping systems necessary for regulatory and ISO compliance.
- Properly handle and dispose of all hazardous waste generated during routine functions.
- Cross-train staff on job functions to ensure continual lab operation and avoid delay of testing.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Possess expertise and proficiency with advanced analytical techniques and state-of-the-art laboratory instrumentation.
- Be able to read, analyze, interpret, and author testing methods and standard operating procedures.
- Be capable of extensive problem solving and project design with original thought and moderate supervision.
- Be able to work independently, and to interact with scientific peers in an effective manner.
- Be willing to work extended hours, weekends and holidays when needed.
- The position requires extensive standing. The employee is regularly required to walk, sit, and reach with hands and arms.
- The employee must occasionally lift and/or move up to 50 pounds.
EDUCATION and/or EXPERIENCE: Bachelor of Science in Chemistry, Biochemistry or related field and three years
of laboratory experience or equivalent combination of education and experience.
WORK ENVIRONMENT: Work is carried out in an analytical laboratory. There is considerable exposure to raw
materials and chemical reagents. Personal Protective Equipment such as lab coats, gloves, safety glasses and respirators
must be worn as defined by safety policy.