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Quality Assurance Associate

Company: Nucleo Life Sciences
Location: San Rafael
Posted on: June 7, 2020

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.Quality Assurance Specialist Summary:The successful Quality Assurance candidate will be responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by performing the following duties.Responsibilities Include:Ensures compliance with cGMP, Company SOPs and Regulatory requirements during all phase of operations.Provide training on quality assurance and Regulatory compliance topics.Oversight of the vendor management program.Maintains the records for calibration on process equipment.Maintains and oversees documentation control of all regulated documents using Quality Management System.Prepares and maintains record for change control, planned or unplanned deviation, customer complaint investigation report, mock recall, annual GMP training.Perform line clearance, issue batch records prior to manufacturing.Disposition raw materials for use in pharmaceutical goods.Updates and maintains records including training, SOPs, Validation and Calibration documentation.Assesses incoming complaints and escalate issues that require Management immediate attention.Participates in internal and external audits.Skills:Knowledge of Federal and State RegulationsKnowledge of pharmaceutical manufacturing practices, validation methods, inspection and testing methodologiesProficient computer skills, (MS Word, MS Excel and Power Point) are essentialAbilities 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:Minimum Education: Bachelor's degreeMinimum 2 years Quality Assurance experience in a regulated environment

Keywords: Nucleo Life Sciences, San Rafael , Quality Assurance Associate, Other , San Rafael, California

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