Research Assistant III-Method Validation (BioA)

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: 'times new roman', times;"><strong><span style="font-size: 12pt;"><span style="font-size: 12pt; color: black;">Excellent Opportunity for an experienced Chemist to join our BioAnalysis group in Madison, WI. Covance’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work. Help improve patients' lives while growing your career.</span></span></strong></span></p><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #636363;"> </span></p><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: #636363;">In this role, you'll perform method validation for various compounds and components in a variety of biological matrices using mass spectrometry with high performance liquid chromatography and work in compliance with appropriate standard operating procedures (SOPs) and regulatory agency guidelines.</span></p><ul><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Performs Method Validation or Qualification (or Method Development with assistance) including study organization, method setup, extraction, instrumentation and result quantitation and evaluation.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Demonstrates high standard of integrity, quality culture, personal responsibility, and respect for individual and client confidentiality. Acts as an example to others. </span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Demonstrates understanding of regulatory compliance through training, and performing work with regulatory guidelines (e.g. GLP, GCP)</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Performs method or instrument troubleshooting and contributes to scientific discussion with internal team to resolve.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Basic understanding of data interpretation and informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect integrity of data, participates in corrective action of problems.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Intermediate analytical instrumentation (mass spectrometry and high performance liquid chromatography) skills</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Maintains laboratory records and performs self or peer review of method validation results and data records for accuracy, and completeness</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Deliver training in relevant techniques/procedures</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Demonstrates a flexible and adaptable attitude to changes and/or challenges in schedule or laboratory work</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Maintains a clean and safe laboratory work environment</span><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">, and keeps space inspection ready</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Participates in new equipment and instrument assessment and qualification, as appropriate.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Participates in process improvement initiatives providing feedback in group discussions or with assistance of supervisor</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Effectively plans and utilizes personnel and resources for timely completion of assigned projects.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Assists in writing or reviewing methodology, protocols and standard operatoring procedures or other documents.</span></li><li style="margin-left: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif; color: black;">Performs other related duties as assigned</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="color: #000000;"><span style="font-family: 'times new roman', times; font-size: 12pt;">Bachelor of Science/Arts (BS/BA) degree in chemistry or related scientific field</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: 'times new roman', times; font-size: 12pt;">Relevant Bioanalytical experience may be substituted for education </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: 'times new roman', times; font-size: 12pt;">Ability to perform basic computer skills (e.g., Word, Excel).</span></li></ul><h2>Experience:</h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: 'times new roman', times;">4 years related or relevant laboratory experience required with a BS/BA degree.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges).</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Experience with use and trouble shooting of analytical equipment.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Effective communication (verbal and written), presentation and interpersonal skills.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Ability to design and independently conduct tests for chemistry projects and provide initial analysis of results.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Acts as technical resource for the department (trouble shooting, method development, qualification, maintenance and training).</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Evaluates data for incorporation into written reports.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Advanced time management skills to complete project assignments on time, with minimal or no supervision.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Able to effectively schedule resources.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Understands and helps staff with compliance to SOPs and other regulatory agency guidelines.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Identifies process improvement opportunities, recommends solutions and implements action plans.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Able to effectively communicate, both verbally and in writing.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Effectively interacts with internal and/or external clients.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Acts as a project leader.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: 'times new roman', times;">Ability to assist in the preparation of relevant sections of final reports.</span></li></ul>