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- San Diego, CA
- Michael Kochka
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QC Data Review (HPLC)
Aerotek • San Diego, CA
Posted 8 days ago
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A Pharmaceutical company in Sorrento Valley is now hiring a QC data review scientist. This job will involve mainly performing HPLC data review with minimal lab work involved.
Essential Duties and Responsibilities:
- Independent execution of HPLC methods and preparation of sample, data packets, and data summaries
- Analysis of pharmaceutical products, including the set-up and execution of GMP in-process, release and stability testing using a variety of analytical techniques
- Creation of stability data sheets and Certificates of Analysis to summarize analytical testing and participation in revision of protocols and test methods
- Participation in Out of Specification investigations and the writing of analytical variances
- Prepare documents and technical reports for clients
- Understand and apply ICH and FDA guidance where needed
- Understanding of cGMPs, Pharmatek SOPs and Pharmatek systems applicable to work performed
- B.S. degree in a physical or biological science, Chemistry preferred.
- Chemist II: 3-5 years of applicable laboratory experience, or a MS in a scientific discipline with 0-1 years of applicable laboratory experience
- Chemist III: 5+ years of applicable laboratory experience, or a MS in a scientific discipline with 2+ years of applicable laboratory experience
- Strong written and oral communication skills.
- Excellent accountability, high attention to detail, and strong organizational skills
- Proficient in a variety of analytical techniques (HPLC (including reversed-phase chromatography, ion-exchange chromatography, enantiomeric purity), dissolution, GC, UV/Vis spectroscopy, general wet chemistry, and compendial methods such as Karl Fischer analysis and FT-IR) and have ability to become familiar with many common standard lab practices in order to assess the quality of pharmaceutical products under limited supervision.
Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit aerotek.com.