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Quality Control Chemist

Company: Nucleo Life Sciences
Location: San Rafael
Posted on: November 20, 2019

Job Description:

Nucleo Life Sciences, LLC. is a pharmaceutical company located in San Rafael, CA that develops innovative therapies into commercially viable products through proven pharmaceutical development expertise and creative problem solving. Nucleo offers specialized Chemistry, Manufacturing, and Controls (CMC) services to strategic partners. We are looking for highly motivated and talented individuals to join our team to bring new drug candidates into clinical development.Summary:The successful Quality Control Chemist candidate will be responsible for all QC analysis and testing to support the release of raw materials, intermediates, and final product. He/she will also support GMP stability studies and equipment cleaning verification for GMP production. -The following is a list of essential duties and responsibilities for this position along with other supportive duties. This list is not all-inclusive.Job Description:Apply basic scientific knowledge related to analytical chemistry for the analysis of small molecule dosage forms.Learn and follow all Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs).Perform GMP testing for the release of raw materials, intermediates, and final product and document all test results with adherence to GMP guidelines.Perform GMP stability testing and document results. Perform GMP review of analytical data and manufacturing documentation.Execute method transfer and validation protocols and document results.Execute experiments to improve and optimize analytical methods with guidance from experienced team members to support method transfer and validation activities.Prepare Certificate of Test and other reports summarizing GMP data as needed.Revise SOPs, test methods, and GMP documents with guidance.Perform cleaning validations and verifications as required.Perform instrument verification and contribute to laboratory organization and compliance.Skills:Experience and understanding of working in a GMP environment and adherence to compliance specifically in QC.Experience in Quality audits.Knowledge of the requirements for Cosmetic and Pharmaceutical products.Experience in analytical chemistry techniques and methods as they relate to the analysis of small molecule drug substance and drug product (HPLC, Dissolution, Karl Fisher, IR, UV-Vis, and pH)Experience in microbiological testing and environmental testing.Proficient computer skills, (MS Word, MS Excel and Power Point) are essential.Abilities and Personal Characteristics:This is a highly collaborative environment where willingness and ability to communicate and work flexibly within a team is essesntialCommitment to safetyStrong interpersonal skillsProven ability and success at working independentlyProven ability to multitask and planStrong attention to detail and oral and written communication skills.Strong problem identification/analysis and sense of accountability, responsibility, and ownership of projects and tasks.Qualifications:Science degree required.Minimum 2 years Quality Control in a laboratory environment.

Keywords: Nucleo Life Sciences, San Rafael , Quality Control Chemist, Other , San Rafael, California

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