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Sr. Manager QC & Stability Ops

Company: Tergus Pharma
Location: Raleigh
Posted on: November 11, 2019

Job Description:

Job Purpose: This position ensures compliance for Analytical, Stability Data and Data Review and documentation compliance with GMP regulations and internal procedures within a GMP analytical and manufacturing facility.
Summary of Key Responsibilities: ---Approval of QC analytical test methods, protocols and specifications; ---Management of the teams to ensure the workload is scheduled appropriately to meet customer Release testing schedules and stability pull dates and timelines.---Ensure all data is reported through the appropriate channels of communication - Customer Certification of Analysis to external and stability databases internally.---Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements ---Managing, Develop, and Maintain a diverse professional staff of Analytical Scientists and Data Reviewers with responsibilities for in- process, finished products, raw materials release, stability sample testing, analytical method development validation. ---Manage staff while promoting team collaboration and ensuring balance of workload and responsibility.
Required Qualifications and Skills:---B.S. in a scientific discipline.---8+ years' experience in a Quality Assurance role in the pharmaceutical industry---Must have at least 3 years of recent CMC regulatory experience.---Experience in managing Analytical and Stability Teams---Experience using SLIM software for collection and calculation of Stability data and trending.---Experience in Data Review of Analytical data per GDP guidelines.---Proven ability to review and evaluate the compliance and completeness of analytical data.---Thorough knowledge of GxP regulations---Proven ability to collaborate with technical staff and customers---Is thorough when performing work; conscientious about attention to detail; uses logical thinking that is well organized and methodical---Able to multi-task productively, applying time management processes and procedures effectively---Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working with others to correct problems---Works toward common goals by supporting, encouraging and sharing information with colleagues

  • ---Speaks, writes, listens and presents information in a logical and articulate manner

Keywords: Tergus Pharma, Raleigh , Sr. Manager QC & Stability Ops, Executive , Raleigh, North Carolina

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