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Specialist, Quality Control

Cambridge, MA 02142

Posted: 05/23/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 556067 Pay Rate: 50.00 Is job remote?: No Country: United States

Job Description

The Role

We are seeking a Quality Control Chemistry Specialist with strong chromatographic (LC/GC) experiences and troubleshooting skills. Individual in this roll is highly independent and self-motivated. He/She must have demonstrated solid scientific and technical breadth to support analytical test methods used in a biopharmaceutical manufacturing facility. The person in this role will assist lab management in OOS/OOT/OOE/LE investigation, troubleshooting methodologies, providing corrective actions and preventive actions (CAPAs), and SME training for the department. This role is assigned to the 3rd shift from Wednesday to Saturday (4 x 10 hrs., 10 pm to 8 am).

Here's What You'll Do
  • Perform QC analytical chemistry testing including, but not limited to HPLC, UPLC, GC, UV, CE, Particle Count analysis, and Dynamic Light Scattering, KF, Osmolality, Digestion, etc,
  • Ensure the analytical testing and laboratory documentation meet cGMP and GDP requirements.
  • Perform raw material, in-process (STAT), finished product and stability sample analysis when needed.
  • Support method validation/transfers and special projects as assigned
  • Ensure stability testing completed within the required timeline.
  • Perform troubleshooting methods and equipment
  • Actively support OOS, OOT, OOE, QE and LE investigations and be able to write investigation reports.
  • Participates quality event investigations such as deviations, change controls, CAPAs, effectiveness check issue the related documents and follow through the event closure as needed.
  • Performs data trending and supports analysis as necessary
  • Serve SME, conduct trainings and provide coaching to help developing the junior chemists
  • Assist in preparation for regulatory, customer and internal quality audits
  • Assist management to identify method gap, area for improvement and work on continuous improvement projects.
  • Performs general laboratory support activities including reagent preparation, sample management
  • Write/revise SOPs, protocols and reports if applicable
  • Emphasize safety in Chemistry laboratory, identify safety risk and provide the risk mitigation actions.
  • Additional duties as may be assigned from time to time

Here's What You'll Need:
  • Minimum education required: Bachelors degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
  • Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry

Preferred Qualifications:
  • Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis
  • Have in-depth knowledge of Analytical Chemistry theory (especially chromatographic separations by HPLC) and the operation of analytical laboratory equipment
  • Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC/GC and the operation of general analytical laboratory equipment
  • Be able to provide appropriate training of proper technical training to lab analysts.
  • In-depth knowledge and expertise in method transfers/qualifications/validations
  • Solid knowledge on cGMP, USP/EP/JP compendia testing requirements
  • Strong communication skills as well as organizational skills
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment while maintaining good quality
  • Details and results oriented
  • Solid technical writing and data interpretation skills.
  • Outstanding ability to multi-task
  • Strong sense of urgency
  • Ability working under pressure while maintain high quality
  • Ownership to the projects and commitment to meet the timelines
  • Solid knowledge of lab safety
  • Highly proficient use of Microsoft Word and Excel, Chromatographic Software
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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