Job Description

Must Haves:

• Bachelor's Degree in Biology, Chemistry, Biochemistry, or other related field
• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
• Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.)
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.
• Experience with applicable instrumentation and troubleshooting.

Nice To Haves:

• Advanced Degree

Job Description:

Insight Global is seeking a Biochemistry Analyst in Durham, NC. The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 2 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.

Responsibilities:

• Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.
• Investigational writing of INVALID reports.
• Provide input and support for Out of Specification reports.
• Serve as a certified trainer for laboratory testing as applicable.

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