Job description

Job Title: QC Chemistry Analyst Specialist
Location: Norwood, MA
Length of Assignment: 6 Months
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Job Description:
We are seeking a Quality Control Chemistry Specialist with strong chromatographic (LC/GC) experience and troubleshooting skills. The individual in this roll is highly independent and self-motivated. Consultant 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.

Duties/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.

Educational Qualifications:

*Must have Chemistry degree. Will consider Biology degree.

Job Type: Full-time

Pay: Up to $52.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

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

Experience:

• QC analytical chemistry testing: 3 years (Required)
• HPLC, UPLC, GC, UV, CE, Particle Count analysis: 3 years (Preferred)
• lab management in OOS/OOT/OOE/LE investigation: 3 years (Required)

Work Location: In person

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