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The Steely Group http://www.thesteelygroup.com http://www.thesteelygroup.com true
Specialist, Quality Control - Wed-Sat Third Shift
Norwood, MA 02062 US
Posted: 03/31/2023 2023-03-31 2023-07-07 Employment Type: Contract Job Category: Quality Job Number: 3542
Our client is 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.
- 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
- 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
- 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