2nd Shift Chemist II


Job ID 17-00222

Industry Pharma

Job Type Contract

Location Somerset, NJ

Description

SUMMARY:
The quality control chemists perform the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations which require chemical analysis. This is a second shift position.
ESSENTIAL FUNCTIONS: • Testing of raw materials. • Physical and chemical testing of bulk, pre-fill, finished and stability products. • Maintaining stability sample data sheet. • Maintaining laboratory notebook and checking the work of others. • Maintaining the work area in an orderly manner. • Keeps current with all SOP's dealing with their job assignments. • Reports any problems with assays or components to the QC Lab Supervisor. • Responsible for preparing and standardizing any reagents or standard materials required for analysis. • Reports any supply needs to the QC Lab Supervisor. • Disposes of unused samples and laboratory waste in appropriate containers. • Performs calibration of lab instruments. • Write method verification protocol and reports. • Performs Method Verification. • Performs equipment troubleshooting. • Maintain lab equipment in good working order. • Assign and monitor Lab Technician and Chemist I job assignments. • Ability to train and mentor Lab Technician and Chemist I.
ADDITIONAL RESPONSIBILITIES:
Other duties will be assigned as required. Include the following. Other duties may be assigned. Analyzes samples of pharmaceutical finished products, in-process samples and others including research oriented samples. Responsible for conducting investigations on aberrant results. Participates in collaborative studies and may serve as a team leader for a project or study. Training other Chemists to properly perform laboratory procedures. Recommending changes to test methods or laboratory procedures to reduce variability and/or improve efficiency. Assist in the day to day maintenance of QC laboratory such as safety, ordering and receipt of lab supplies



Qualifications

Qualifications:
EDUCATION AND EXPERIENCE: 1. BA or BS in chemistry with five years of experience in a lab performing chemistry related duties. 2. Experience with High Pressure Liquid Chromatography, Infra-Red (IR), Gas Chromatograph (GC), Ultra Violet/Visible, Particle Size Analysis, KF Titration and wet chemistry skills is required. Familiarity with HPLC/GC analytical software. 3. Familiarity with GLP/GMP guidelines. 4. Good Communication and writing skills. 5. Familiarity with out-of-specification (OOS) and out – of –trend (OOT) investigations. 6. Write OOS and OOT reports 7. Computer literate. 8. Experience with USP/EP monographs.
JOB PREREQUISITES: Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours during the week and/or weekends in order to get the required tasks accomplished to meet deadlines.
JOB PREREQUISITES: Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
Requires prolonged sitting. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports. Mental Requirements include: Ability to hear accurately the spoken word with moderate office noise or plant noise Ability to apply deductive reasoning and understand complicated issues Ability to receive instructions and follow work rules and company policies Ability to follow safety and security practices Ability to meet deadlines and effectively deal with office stress Ability to accurately communicate ideas, facts and technical information Maintain confidentiality of certain information