Quality Control Chemist
4 weeks ago
Responsibilities:
- Excellent employment opportunity for a QC Associate II in the Fremont, CA area.
- Executes and coordinates routine and non-routine testing in QC of bulk drug substance and drug product in a multi-product facility.
- Executes independently with adequate training fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolality
- Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
- Delivery of high-quality analytical results within timeline right the first time
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- Reports abnormalities and deviations in a timely and accurate manner.
- Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
- Maintains work production areas according to predefined standards (5s).
- Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
- QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments
Experience:
- Bachelors' degree in Biology or Life Sciences required
- 3-5 years of industry experience
- GMP experience is highly preferred
- Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
- Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals.
- Demonstrates strong attention to detail, and an ability to focus on details of execution
- Schedule Notes: 1st Shift: Monday-Friday: 9AM to 6PM Some overtime and weekends may be required as needed.
- Required Skills: HEALTH AND SAFETY, ANALYTICAL HPLC, LIFE SCIENCES, SOP, GMP
- Additional Skills: STOCKING, ROOT CAUSE ANALYSIS, SAFETY STANDARDS, CGMP, BIOCHEMISTRY, OPERATIONS, RISK ASSESSMENTS
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