Job Description
Lab Quality Control Analyst – (Onsite) – Contract – Northeastern Ohio
Biotechnology Research organization seeks a Lab Quality Control Analyst for an onsite 6-month contract with potential extension. This requires a Monday thru Friday 3pm to 11:30pm ET shift as well.
Additionally, 1+ year of laboratory expertise within a related industry, and as a Quality Control Technician are also a requirement. This individual will require a Chemistry Degree/Background, various lab instrumentation exposure, and wet chemistry experience is preferred. This person will perform routine and non-routine chemistry and microbiological analysis of raw materials, as well as Environmental Monitoring duties. Individual will review for data discrepancies, manufacture COAs/COCs and complete documentation accordingly, while ensuring accuracy. Opportunity requires location proximity just southeast of Cleveland, OH as this is an onsite position.
Requirements:
- A bachelor’s degree in chemistry, biology or biochemistry, or related work.
- Local to Aurora Ohio.
- Ability to work onsite from 3pm to 11:30pm ET.
- 1+ years as Quality Control Technician, as well as a background in Chemistry.
- Wet chemistry expertise preferred to include Acid/Base Titrations, water content, Bioburden, Endotoxin.
- Expertise with various lab instrumentation.
- Familiarity with MS Office to include Word, Excel, and Access.
Responsibilities:
- Conducting routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations, and final products to establish specifications.
- Utilization and operation of lab equipment and instrumentation in accordance with lab work instruction and procedures (pH, UV, KF, FTIR, Conductivity, and titrations).
- Understanding and following QC Test Methods and Compendial Methods to include USP, EP, BP, JP or ACS, as well as EXCIPACT standards.
- Calculating and generating data for compliance into specifications, reporting results.
- Performing technical lab data form review to include water, environmental monitoring and direct measure analysis.
- Calibrating and maintaining laboratory equipment based on specific needs.
- Entering results and raw data for tested materials and products into LIMS as needed.
- Performing investigative analysis and supporting investigations, complaints and instrument troubleshooting as required.
- Performing Environmental Monitoring tasks, requiring work within cleanroom and collection of air and surface samples.
- Reviewing data for discrepancies, manufacturing COAs, COCS, and performing data verification in accordance with organizational best practices and standards.
- Applying appropriate label identification to materials.
- Handling hazardous materials utilizing appropriate and mandatory safety protocols and equipment.
- Completing documentation in an accurate and legible way, while performing other tasks as assigned.
- Performing sampling and testing for USP Purification of water and water for injection.
- Authoring, reviewing, and updating all lab procedures and instrument work instruction.
- Performing microbio tests like bioburden, endotoxin, Dnase, Rnase, Protease, and Phosphatase using proper aseptic techniques.
- Preparing and properly disposing of microbial media.
- Benefits:
- A 6-month contract within a stable and successful organization with the potential to extend.
- Ability for a consultant to work W2, with or without benefits.
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