Details: Kelly Scientific has an opening for a Method Development and Validation HPLC Chemist in the Orange County Area Long Term contract positionShift: M-F 8-5pmSalary: Negotiable DOE ESSENTIAL JOB DUTIES/RESPONSIBILTIES - Performing wet chemistry, HPLC, GC, Dissolution test, UV, PH. - Performing analytical tests of raw material, in-process, and finished products. - Calibrating instruments used for QC testing. - Documenting test results, problems and other issues, performing initial troubleshooting issues that arise during analysis, conducting all analysis and documentation using GMP and FDA guidelines. - Investigating OOS issues and implementing corrective actions. - Performing laboratory instrument validations (IQ, OQ, PQ). - Performing method validations, method research, writing protocols and method development - Performing cleaning validations. - Execute method validation protocols and write reports QUALIFICATIONS - BS Degree in Chemistry or related subject (MS or PhD highly preferred) - Minimum of seven (7) or more years of work experience performing analytical chemistry in a regulated industry (i.e. Pharmaceutical, Biopharmaceutical, and/or Nutraceutical) and work experience conducting validation (instrument, method, cleaning and process) and method development - Proficient use of the English language (verbal and written) - Excellent written and oral communication and presentation skills and techniques. - Effective planning & organizing skills. - Ability to handle multiple task/duties. - Knowledge and understanding of quality in a manufacturing environment, as well as laboratory controls and work safety rules/regulations. - Ability to execute validation protocols and reports. - Must know cGMP protocols and requirements for 21 CFR Part 111 or 211 best lab practices - Proficient math skills (addition, subtraction multiplication and division in all units of measures, using whole numbers, common fractions and decimals. - Ability to compute rate, ratio, percent and to draw and interpret bar graphs. - Ability to maintain a high-level of confidential information in the performance of job duties. - Ability to present information in one-on one and small group situations with customers, management, and other employees of the organization. - Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management and employees. - Ability to adapt effectively to workplace changes and new job duties/responsibilities. - Ability to represent the Company in a positive and professional manner at all times. - Effective trouble shooting, problem solving skills. - Willing to work late and/or during weekends; if needed. Interested applicants should apply directly below to the on-line resume builder link. To follow up interested candidates may call us at 714-971-0721.

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