Quality Control Chemistry Specialist
Norwood, MA 02062 US
Target PR Range; 31-35/hr
*Depending on experience
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 Sunday to Wednesday (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 Qualifications)
Minimum education required: Bachelor’s 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
Here’s What You’ll Bring to the Table (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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