Quality Control Analyst II - OQSIE
Northborough, MA
About the Job
Duties:
Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. Conducts data review and preliminary evaluation of results. Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provides input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience: 3 to 6 years
Skills:
Education:
Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. Conducts data review and preliminary evaluation of results. Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provides input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience: 3 to 6 years
Skills:
- Testing of raw material packaging and components including visual inspection and dimensional analysis
- Testing of chemical raw materials utilizing FT-IR, wet chemistry, Karl Fisher, titrations, Polarimetry, Specific Gravity, GC, and RAMAN
- Conduct tasks for laboratory equipment qualification and re-qualification program
- Review compendial updates and initiate workflows for corresponding revision of test methods
- Review of laboratory data
- Support ongoing readiness for regulatory inspections and compliance audits
- Revise SOPs
- Practice safe work habits and adhere to Sanofi's safety procedures and guidlines
- Maintain proficiency training per assigned curricula
Education:
- Associate's degree and/or 4 years of cGMP laboratory experience
- Preferred Qualification: Bachelor's degree in Chemistry or Biology and minimum 2 years experience in a cGMP environment
- Previous experience in Microsoft Word, Outlook, and Excel
- Scientific technical writing capability
- Ability to lift up to 50 lbs
Source : OQSIE
