QUALITY CONTROL SCIENTIST
What will you do?
- Work in a fast-paced GMP environment performing testing using various analytical techniques, such as HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.
- Record and report results of analysis in accordance with lab procedures, GDP, and ALCOA.
- Review and interpret analytical test results. Make recommendations based on data.
- Recognize and report deviations, out-of-specifications OOS, or unexpected results and recommend solutions.
- Maintain a clean and organized laboratory workspace consistent with management expectations.
- Clean, calibrate, and troubleshoot analytical instrumentation as needed.
- Author Standard Operating Procedures (SOPs), deviation reports, and other documents as needed.
- Collaborate with various functional areas to meet project and team objectives.
- Manage projects at a broad task level under minimal supervision, ensure deliverables are met and identify next steps.
- Train other scientists.
- Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
Maintain the necessary compliance status required by company and facility standards.
Education
Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.
Experience
- At least 3 years working in a regulated laboratory environment. GMP experience preferred.
- At least 2 years of HPLC experience performing assay / related substance analysis and other chromatographic techniques.
Experience with Empower software is preferred.
- Experience with dissolution and other analytical techniques is preferred.
- Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
- Hands-on experience with various analytical techniques, including : HPLC, GC, Dissolution
- Ability to work independently and in a team setting.
- Strong knowledge of Good Manufacturing Practices and data integrity (ALCOA).
- Good critical and logical thinking skills.
- Ability to read, analyze, and interpret technical procedures and governmental regulations.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Typically requires standing and walking for a shift.
- Occasionally requires lifting of up to 20 pounds.
- Requires manual dexterity and visual abilities.
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