Specialist Manufacturing # JN -072021-67527

Thousand Oaks, California
Industry: Procurement / Supply Chain
Job Number: JN -072021-67527

 Description:

Job Description

  • The Specialist, External Supply is expected to manage nonconformance, CAPA, CAPA-EV, SICAR, EN, and Change Control quality records
  • He or she will act as the External Supply representative on cross functional teams and drive closure of supplier related quality records in a timely manner
  • The Specialist, External Supply owns and manages quality records originating from manufacturing sites across the Client network

 

Responsibilities:

  • Addresses and closes quality records and deviations under the company's quality management system procedures and ensures compliance with regulatory agency requirements
  • Monitors and investigates deviations and implements corrective and preventive actions
  • Manages closure of multiple quality records simultaneously
  • Ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures
  • May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.
  • Will participate in cross functional teams to drive closure of multiple quality records simultaneously

 

Basic Qualifications

  • Master’s degree and 2 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries

OR

  • Bachelor’s degree and 3 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries

 

Preferred Qualifications

  • 2+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems
  • Good understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations
  • Good working knowledge of EU and US cGMPs regulations
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
  • Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach
  • Strong organizational savvy
  • Able to build effective relationships across various departmental functions
  • Excellent interpersonal relationship skills
  • Excellent Technical Oral and written skills, ability to write/evaluate investigation responses that will comply with regulatory requirements
  • Proficient with MSWord; MSExcel; MSPowerPoint; MSVisio; MSProject, Trackwise
  • Demonstrated ability to deliver results through living the Client values
  • Strong negotiation skills when working with external suppliers and internal team members
  • Ability to maintain remote working relationships with colleagues at other Client sites


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