QC Chemist: Cepheid

Perform testing of incoming materials, and finished products for release to support Quality Systems objectives. Requires knowledge of cGMP's and regulations applicable to the FDA and international regulatory agencies. Activities are performed in accordance with FDA Quality System Regulations and ISO standards.

Requires a Bachelors degree in Science, preferably Biochemistry or Molecular Cell Biology with knowledge of PCR and real time PCR a plus. Minimum of 2 years related experience and demonstrated working knowledge of scientific principles in the in-vitro diagnostic (IVD), medical device and/or pharmaceutical industry. Knowledge of quality and lab processes, methods and techniques required.

Duties & Responsibilities -
- Perform hands-on laboratory activities related to raw material and product release testing.
- Perform data entry and analysis to support product testing according to established methods while measuring results against specifications.
- Support studies for internal customers and change control activities.

Knowledge & Skills -
- BS in Biochemistry, Molecular Cell Biology or similar field.
- Minimum of 2 years of hands-on laboratory and/or manufacturing experience in a GMP environment is required.

- Working knowledge of real time PCR is preferred.

- Knowledge of analytical chemistry techniques and protocols is highly preferred.

- Effective organization and planning skills.
- Able to work with minimum supervision.
- Working Knowledge of GMP, ISO, and QSR regulations highly preferred.
- Effective problem solving and analytical skills.
- Effective interpersonal skills.
- Effective written and verbal skills.
- Excellent computer skills; especially proficient in Excel and Word.