QC Chemist

• Will abide by all cGMP, FDA and DEA regulatory standards
• Performs routine analysis on samples submitted for testing on time and accurately
• Performs basic maintenance/ troubleshooting of instruments
• Documents results in accordance with cGMP and as per LTS SOP’s
• Informs supervisor of any deviations in results/procedure from established specifications or procedures
• Adherence to policies/procedures (SOP’s, cGMP’s, safety protocols)
• Ability to identify areas of improvement and provide action plans/viable options/alternatives to laboratory management
• Provides input for lab investigations, CAPAs, and Change Controls
• Any other functions as required by Quality Control Unit

• Bachelor’s degree
• Minimum 5 years’ experience in a cGMP environment 
• Experienced in GC and HPLC testing and troubleshooting of chromatographic issues. 
• Above average reading, writing, math, and verbal skills
• Excellent team player
• Proficient in word, excel, and power point
• Able to wear safety glasses, hearing protection, full face/half mask respirator, latex gloves, Tyvek suit and other safety equipment as needed
• Basic use of tools and equipment
• Experience with computerized Data Acquisition Systems
• Above average knowledge of chemistry and/or biochemistry
• Ability to lift or move 1-24 pounds

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.