Responsible for testing of raw materials, bulks, components and kits in compliance with QSR, ISO, OSHA, IVDD, MDD regulations and relevant Standard Operating Procedures. Trains others to perform routine tasks. Takes on additional responsibilities related to QC Laboratory maintenance.
- Performs testing as assigned for all QIAGEN product lines.
- Prepares data for review and enters assay results for batch records.
- Initiates Out of Specification (OOS) form to document failure and investigation.
- Works toward increasing technical knowledge and skills and understanding of the theory behind testing procedures.
- Able to independently follow protocols and address issues with instruction.
- Maintains QC Reagent set and data trending of assigned product line or other equivalent responsibility.
- Troubleshoots assays under direction of the Supervisor/Manager.
- Trains new employees as assigned.
- Demonstrates the ability to work independently as well as in a team environment.
- Advises supervisor of factors that may affect quality, accuracy and usefulness of data.
- Assists in updating SOPs and specifications to maintain current documentation.
- Minimum of AS degree in scientific discipline with 2 years of relevant experience or 1 year of experience as a QC Scientific Associate I.
- Multiple years of industrial experience will also be considered. cGMP experience is a plus.
- Proficiency in a word processing program (i.e., MS Word), a spreadsheet program (i.e. MS Excel) and a database program (i.e., MS Access) is required.
- Proficient in MS Office applications.
- Ability to use general lab equipment.
- Command of the spoken and written English language is required. Must be articulate and able to communicate effectively with employees at all levels of the organization on the telephone and in person.
- Understanding of metric volumes is required.
- Must be able to follow instructions with minimal oversight. Must be able to continually develop independence in technical troubleshooting. Must take initiative to bring issues to Supervisor/Manager.
- The work environment is fast-paced and involves the ability to quickly change priorities and multi-task while maintaining a professional demeanor. The position requires work with potentially bio hazardous and/or chemically hazardous materials.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.