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Analytical laboratory Data reviewer
1 month ago
Title: Analytical laboratory Data reviewer
Location: Bend, OR
Duration: 6 Months on W2
Exact Schedule - 4x10 Tues-Fri.
Essential Functions;
- Critically reviews testing from the following instrumentation: HPLC, GC, PXRD, Dissolution, DSC, FT-IR and KF.
- Ensures analytical test results comply with internal specifications as well as company and regulatory standards.
- Collaborates with internal scientific, analytical, laboratory and quality functional areas to meet project and team objectives.
- Works closely with, and collaborates with, the Data Integrity Officer and escalates any quality concerns as appropriate to the Quality Unit.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, and safety guidelines.
- Maintains the necessary compliance status required by company and facility standards.
- Working knowledge of Empower or other LMS.
Education
Bachelor of Science in Chemistry, Biochemistry, Biology, Computer, or related science required.
Experience
Some lab experience preferred (2+ years). Experience with Empower.
Experience performing or reviewing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred. Equivalent combinations of education, training, and relevant work experience may be considered.
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies
- Good work ethic and a desire to learn.
- Ability to multi-task and handle shifting priorities in a fast-paced, highly regulated manufacturing environment.
- Effective written and interpersonal skills.
- Attention to detail and the ability to follow written and verbal instructions.
- Excellent critical and logical thinking skills to solve problems.
- Experience with Microsoft Excel, Word, PowerPoint.
- Good knowledge of qualitative and quantitative chemical analysis as it relates to the pharmaceutical industry.
- Understanding of GMP and data integrity (ALCOA).
- Ability to read, analyze, and interpret technical procedures and governmental regulations.
- Ability to write standard operating procedures, protocols, and reports.
- Looking for chemistry or similar background & experience with empower lab data acquisition systems.
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