Job Summary
POSITION SUMMARY
A Scientist II in Quality Control displays an advanced knowledge in chromatographic techniques and instrumentation, and guides others in troubleshooting instrumentation and routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group.Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
· Be able to articulate work related issues clearly and effectively to management and peers
· Performs accurate routine and non-routine testing utilizing instrumental methods of analysis (HPLC, KF, TLC, FTIR, pH, UV-Vis) with emphasis on chromatography to meet departmental objectives.
· Cross trained and capable of running the majority of analytical tests within the QC department.
· Supports senior personnel in various projects including investigations.
· Assists in authoring basic investigative studies (required for OOS or OOT results) and other necessary documents for the Quality Control department.
· Documents testing in compliance with Good Documentation Practices
· Assists in the formal training of lab personnel on topics such as GMP, safety, antineoplastic, and new employee training.
· Teach or coordinate teaching of training modules and laboratory techniques to new analysts as a QT and/or mentor.
· Performs complex routine and non-routine QC Chemistry testing (wet chemistry and chromatographic/instrumental) as required.
· Performs peer review of data to ensure compliance and accuracy.
REQUIREMENTS
· Possess a B.S. in Chemistry, Biology or related physical science. Typically, 3-6 years of related experience in pharmaceutical industry. Excellent written and oral skills are required.
· Must be proficient in Microsoft Office (Word, Excel, PowerPoint).
· Must have hands-on experience and advanced knowledge of chromatographic methods, Chromatographic Data Systems (i.e. Empower), cGMP and FDA regulations.
· Must be flexible with continually changing projects and priorities.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Top Skills
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
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