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Sr. QA Specialist, Supplier Qualification and Auditing

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Date: Mar 31, 2021

Location: PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Primary Duties

Working under minimal supervision, the Sr Quality Assurance Specialist, Compliance will work closely with QA and Manufacturing Functional Management to identify strategies, tactics and objectives for product quality and GMP compliance:

 

  • Perform external audits of vendors and suppliers and generate reports providing recommendations on results of audit
  • Perform internal audits of GMP and other departments as needed to assess compliance with approved operating procedures and GMP regulations
  • Review/Approve/Write/Revise Standard Operating Procedures related to departmental activities
  • May act as a mentor, providing general guidance and instructions to less senior members of the team
  • Generate trending reports to update management of various department on GMP Compliance status
  • Manages receipt, response to and record keeping of product complaints
  • Manage the Quality Agreements Program

 

Responsibilities

  • Conducts internal and external audits and works with vendors / internal departments to ensure appropriate responses are submitted in timely fashion
  • Manages and tracks corrective actions (CAPA’s) and works with departments on completing them on time
  • Works with functional departments in collecting data trends of critical operations within these departments and generated trending reports for cross functional review
  • Manages product complaint system
  • Helps maintain supplier qualification schedule and vendor status reports
  • Assists Training Lead in ensuring training programs are compliant and up to date
  • Support preparation of regulatory submissions
  • Other assigned responsibilities as established by QA Lead

 

Education and Experience Requirements

 

  • BA/BS in scientific discipline required or equivalent work experience
  •  A minimum of 5-7 years in a global pharmaceutical manufacturing environment with exposure to Quality and Manufacturing field
  • Experience in conducting internal and external audits 
  • Broad working knowledge of relevant governmental regulations, cGMP and guidelines (US, EU and other territories where Spark products are distributed), and ability to organize cGMP procedures based on regulatory / compliance regulations
  • Travel up to 25% may be required
  • The position may require occasional shift work, including weekends, off hours and holidays as needed.

  • Key Skills, Abilities, and Competencies

    • Broad knowledge of CGMP Regulations
    • Quality Systems such as Supplier Qualification, CAPA management,
    • Ability communicate effectively with wide range of personnel
    • Solid technical writing skills related to investigation reports
    • Ability to organize cGMP system procedures based on regulatory / compliance regulations
    • Must have strong attention to detail
    • Strong analysis and problem solving skills, including, but not limited to, the ability to review and analyze Manufacturing, Quality Control and validation data
    • Ability to lead (as necessary) and participate on cross-functional teams in root cause analysis and solution identification
    • Proficiency with computer programs

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