- Key Responsibilities:
• Perform appropriate Quality Control activities including analytical testing to support release or rejection of cleaning verification, excipients and packaging components.
• Proposing validation protocols and performing appropriate validation of analytical methods.
• Develop and validate CV methods.
• Author compound specific HPLC rinse and swab methods for secondary CV testing.
• Support B29 Sterile Manufacturing plant as required.
• Raises issues including identification of Atypical and out of specification results.
• Ensuring high quality standards are employed in the work of the team and that issues are raised and resolved.
• Is fully aware of GMP requirements for his/her laboratory/working environment.
• Maintain training records and familiarity with current SOPs and controlled documents.
• Executes experiments based on established protocols and implements improvements with minimal supervision.
• Identifies and begins to interpret any problems in the execution of experimental processes and/or in results and communicates them to supervisor.
• Proactively seeks assistance from other scientists to solve problems.
• Maintains cleanliness in own work area and in communal work areas.
• Anticipates/recognizes potential problems with equipment and/or supplies, and initiates action to solve or prevent problems.
• Works to GMP standards as appropriate.
• Follows safe Laboratory Practices and attends regular safety training.
• Maintains accurate and complete safety records consistent with company policy and legal requirements.
• Recognizes potential safety problems and takes action to rectify them.
• Bachelor's degree in chemistry and five to seven years of related experience in analytical method development and testing of drug substance and/or drug products.
• Experience with HPLC and other chromatographic and spectroscopic techniques.
• Experience with development of cleaning verification / validation (or low-level quantitation) methods.
• Experience leading cross-functional projects across matrix lines.
• Excellent Communication skills required.
SRG Woolf is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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