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QA Senior Compliance Specialist – Operations

QA Senior Compliance Specialist – Operations

CompanySanofi
LocationFramingham, MA, USA
Salary$67500 – $97500
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior

Requirements

  • Bachelor’s with 4+ years of experience, Associates with 6+ years of experience, or High School Diploma and 8 years of related experience in a Quality and/or CGMP environment.

Responsibilities

  • Work closely with manufacturing, facilities, engineering, and Quality Control departments. Function as SME on challenges related to production requiring quality input.
  • Review batch records, logbooks, equipment status documentation, cleaning records.
  • Provide on-the-floor support, issue action notices, and cleaning logs.
  • Represent QA during internal and external audits, addressing questions related to QA systems and product disposition.
  • Approve non significant deviation investigations.

Preferred Qualifications

  • Self-motivated
  • Organized
  • Excellent communicator
  • Detail-oriented
  • Strong interpersonal and project management skills
  • Proficient in electronic document systems such as Trackwise and/or Veeva, Excel, Word, PowerPoint, and databases.