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Sr QC Specialist

United States - California - La VerneQualityRegular
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Job Description

​Job Responsibilities

  • Manages tasks and may manage performance of assigned group of staff in the QC department, to accomplish company and departmental objectives.

  • Assigns, monitors, and reviews progress and accuracy of work of more junior employees.

  • Organizes and prioritizes daily tasks, performs training, writes performance reviews and provides coaching.

  • Provides data review, process trending, and procedural updates and provide technical support for validation protocol.

  • Writes and executes protocols for the qualification and re-qualification of new and current instrumentation.

  • Validates if required improvements to current methods.

  • Performs method and equipment validation and training.

  • Troubleshoots instruments/methods.

  • Reviews facility environmental data for acceptability to Gilead SOPs and policies.

  • Reviews or creates process trending charts for QC Laboratory processes.

  • Supports the LIMS system to provide QC Laboratory method integration and updates.

  • Attends specific project related team meetings and address items pertaining to project as assigned by direct manager.

  • Follows technology changes, recommends new technologies, purchase and implement if appropriate.

  • Schedules projects to ensure that deadlines are met.

  • Follows GMPs and comply with all safety regulations.

  • Interacts with vendors of supplies and equipment.

  • Performs internal auditing of QC Laboratory areas.

  • Approves timecards for more junior employees.

  • Represents the business at external forums.

Knowledge & Skills

  • Strong working knowledge of GMPs, pharmacopoeia and regulatory requirements for testing and validation pertaining to the pharmaceutical industry.

  • Proficient in application of QC principles, concepts, industry practices, and standards

  • Project Management and prioritization skills.

  • Audit and Investigation Skills, Report Writing Skills.

  • Strong verbal, technical writing and interpersonal skills are required.

  • Proficiency in Microsoft Office applications and other LIMS and QC software.

Education & Experience

  • 7+ years of relevant experience and a BS or BA.

  • 5+ years of relevant experience and a MS.

  • Prior experience in pharmaceutical industry is preferred.

  • Prior experience of managing people is desirable.