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Quality Control Chemistry Specialist

Norwood, MA 02062

Posted: 10/04/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 582505 Is job remote?: No Country: United States

Job Description


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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