Scientist

Scientist

Requirements

• BA/BS, or MS in Chemistry, Biochemistry, or related science
• BS degree in Chemistry or related science discipline with a minimum of 5 years’ experience, or MS degree with a minimum of 3 years’ experience
• Related experience in Quality Control, lab work specifically, or experience in Quality Assurance or related experience is required
• Good oral, written, and interpersonal communication skills are required
• Basic computer skills such as data entry
• Candidate must not be Cephalosporin/Penicillin sensitive

Responsibilities

• Coordinate scheduling and prioritization of activities in the chemistry laboratory
• Utilize investigational tools to troubleshoot, identify root cause, and recommend corrective actions
• Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact and recommends appropriate corrective action where necessary
• Provide chemistry support of systems and processes at the site
• Conduct and review non-conformance investigations
• Writes evaluations to support change control
• Helps troubleshoot and assists in determining appropriate corrective actions
• Oversight of laboratory investigations and cleaning validation
• Interface with external partners, senior management, and regulatory agencies to discuss execution of laboratory programs at the site
• Provide subject matter expertise for standard operating procedures and quality standards content
• Recommends and executes process improvements to continually improve laboratory performance

Preferred Qualifications

• Preferred experience includes HPLC, Dissolution, use of Empower3 software and prior experience with GMP documentation
• Key characteristics of a successful candidate in this position: willingness and ability to learn, ability to work in a team environment, and attention to detail