Philips QC Chemist I in Fremont, California

  • Perform routine QC analysis of raw materials, in-process samples, finished products and stability samples by applying problem solving skills and working knowledge of instrumental analysis using HPLC/UV, GC-FID, FTIR, UV, etc.

  • Maintain data documentation and monitor product quality to ensure compliance to standards and specifications

  • Perform analytical test method transfer (HPLC, GC, etc.) from outside laboratories to QC

  • Conduct method validation in accordance with FDA/ICH regulatory guidance

  • Revise and/or write analytical methods, test protocols, standard operating procedures and test reports as needed

  • Perform OOS investigations and summarize the investigations in OOS reports

  • Perform equipment qualifications and calibration procedures to ensure the equipment is providing accurate and precise measurements

  • Maintain the QC lab in accordance with cGMP/company requirements

  • Carry out routine and assigned projects in a timely fashion under minimum supervision to meet deadlines, according to cGMPs, SOPs, and test methods

  • Work to maximize efficiencies through multitasking to increase productivity while consistently producing error-free work

In this role, you have the opportunity to perform and document routine analytical testing of drug-device combination products.

You are responsible for

  • Focus on accuracy and detail to meet company quality standards.

  • Perform routine QC analysis of raw materials, in-process samples, finished products and stability samples by applying problem solving skills and working knowledge of instrumental analysis using dissolution apparatus, HPLC/UV, GC-FID, UV-Vis, Particulate Counter, FTIR, etc.

  • Maintain data documentation and monitor product quality to ensure compliance to standards and specifications

  • Revise and/or write analytical methods, test protocols, standard operating procedures, equipment specifications and test reports as needed

  • Perform OOS/NCMR investigations and summarize the investigations in OOS/NCMR reports

  • Perform equipment calibration procedures to ensure the equipment is providing accurate and precise measurements

  • Work on stability programs, analyze the stability results, trend the data and generate stability summary reports

  • Maintain the QC lab in accordance with cGMP/company requirements

  • Carry out routine and assigned projects in a timely fashion under minimum supervision to meet deadlines, according to cGMPs, SOPs, and test methods

  • Work to maximize efficiencies through multitasking while consistently producing high quality work

You are a part of in the Quality Control analytical laboratory, conducting analytical test method transfers and validations, writing and revising analytical test methods, standard operating procedures, technical reports and OOS/NCMR investigation reports.

To succeed in this role, you should have the following skills and experience

  • Educational Level: BA/BS in Chemistry, Biochemistry or a closely- related field; minimum 5+ years of relevant experience

  • Experience working in a GMP or GLP regulated environment

  • Strong analytical and troubleshooting ability; detail-oriented

  • Good verbal and written skills, good learning attitude

  • Strong organization, record keeping, data analysis, and computer skills

  • Team work oriented with good interpersonal skills

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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