Quality Associate Engineer ( Medical Device ) - Intellectt INC

Role: Quality Associate Engineer ( Medical Device )

Location: Santa Clara ,CA

Duration: 12+ Months

Job Description:

The QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP compliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies. The individual will help maintain the biochemistry laboratory systems, assist in training other analysts, help maintain SOPs and other documents, and promote an orderly and efficient laboratory workplace.

Experience:

Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.

• Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals.
• Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of recombinant proteins.
• Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
• Ability to identify and help investigate assay and equipment problems.
• Fluent in English, good written communication skills; good interpersonal skills.
• Team player who can excel in a "hands-on" entrepreneurial environment.
• Physical requirements: handling of laboratory equipment, chemicals, and biological materials.

Education:

BS in biological or chemical sciences or equivalent