Biochemist 1

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Analyzes and designs work systems in order to support general adherence to agreed standards, in order to ensure humanely and economical production and drives continuous improvement topics.

Position Overview

As a member of the Component Testing Group, this individual will be expected to perform routine and non-routine testing on a variety of materials used in the manufacture of In Vitro Diagnostics (IVD) assays.

Test methods include but are not limited to: gel electrophoresis, spectrophotometric assays, ELISA, protein size exclusion chromatography, water purity analysis.

Additional responsibilities of this position include:


* Preparing reports following Good Documentation Practice.


* Data analysis


* Preparation of test solutions


* Troubleshooting instruments


* Test procedure review


* Nonconformance process and related corrections / corrective actions


* Providing support for general laboratory activites

The successful candidate:


* Must have knowledge of good laboratory practices in a cGMP environment, with strong analytical capabilities


* Must function well under pressure and be able to meet daily commitments and deadlines while continuing to make appropriate decisions regarding product quality


* Must be able to follow procedures under minimal supervision, be confident in their ability to make and defend decisions


* Needs to be flexible and be able to handle ever changing priorities while demonstrating attention to detail, and good technical judgment


* Must be able to communicate effectively with internal customers


* Must recognize the underlying basis for regulations and rules and act in accordance

Required Knowledge/Skills, Education, and Experience


* BS/BA degree in biochemistry, chemistry or related degree.


* Strong computer skills


* Ability to work as part of a team


* Detail oriented and highly organized

Preferred Skills and Experience:


* Knowledge of good laboratory practices in a cGMP environment, with strong analytical capabilities


* 2-3 years of laboratory experience preferred.


* SAP experience, particularly with QM tasks

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