Elkhart, United States
5 months ago
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.
Additional responsibilities of this position include:
- preparing reports following Good Documentation Practice.
- data analysis
- preparation of test solutions,
- auditing instruments,
- test procedure review
- providing support for general laboratory activities.
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 his/her 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
Preferred Skills and Experience:
- Knowledge of good laboratory practices in a cGMP environment, with strong analytical capabilities
- Minimum of 2 years of laboratory experience preferred.
- SAP experience, particularly with QM tasks
- detail oriented and highly organized