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Job Title: Quality Control Analyst II
Duration: 4 Month Plus
Location: Northborough, MA
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
Execute activities, as assigned, for optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials
Testing of 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
Coordinate logistics and communication with contract testing laboratories for supplier qualification testing
Review of data
Support ongoing readiness for regulatory inspections and compliance audits
Practice safe work habits and adhere to Client safety procedures and guidlines
Maintain proficiency training per assigned curricula
Function as primary shift technician for environmental monitoring.
Performs environmental monitoring of ISO class 7 and 8 cleanrooms using viable air samplers and non-viable particle counters.
Collects microbiological testing data (EM and CU)
Perform routine data entry and data trend analysis.
Helps prepare trend reports for management review.
Collects, analyzes and trends facility water to include RODI ports.
Maintain adequate inventory of supplies needed for all microbiological testing including all consumables.
Assists in everyday organization of laboratory including cleaning, maintenance and ordering of supplies.
Perform area cleaning and waste removal, as needed.
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
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