Job description

Title: Specialist, Quality Control
Location: Norwood, MA
Duration:6m+

3rd shift Wed-Sat

Responsibilities:

• 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 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

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

Regards,

Vivek Kumar

IDC Technologies.

Job Types: Part-time, Contract, Temporary

Salary: $30.00 - $40.00 per hour

Benefits:

• Health insurance
• Life insurance
• Paid time off

Experience level:

• 5 years

Schedule:

• Day shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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