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Quality Specialist

Location: Boston, Massachusetts Salary: US$30 - US$75 per hour
Sector: Quality Assurance (QA), Regulatory Affairs Type: Contract

Temporary Quality Specialist

I am looking for a Quality Specialist to join our CMC team. In this role as a Quality Specialist you will have to work independently at a high rate to ensure compliance with all applicable regulatory requirements are met. The Quality Specialist will be responsible to compete all work in both a self-sufficient and resourceful manner. The Quality Specialist may work on multiple projects, and are primarily responsible for specific pieces of moderately complex projects. In this Quality role you will need to have the ability to collaborate cross functionally, as well drive results within the team.

Responsibilities/ Skills

  • Must have a great understanding of global GMP requirements governing Finished Goods as well as solid working knowledge of GDP requirements
  • Must have Flexibility/Adaptability
  • Must have the ability to thrive in a fast paced environment
  • Coaching/ Communication/ Influencing
    • As well as the ability to communicate effectively across all organizational levels
  • Problem Solving/ Critical Thinking
    • As well as the ability to evaluate Quality matters, also making decisions utilizing risk based approach
  • In this role you will work cross-functionally to integrate activities with other departments, groups, and project teams as needed.
  • You will facilitate continuous improvement efforts towards CMO batch release records as needed
  • You will be responsible for performing Drug Product batch disposition activates upon the review of both batch records that have been executed as well as certificate of analysis for commercial products
  • You will need to provide Quality oversight for root-cause analysis
  • You will also be responsible for product impact assessment for investigations as a result of deviations, OOT, as well as OOS investigations to ensure the appropriate CAPA actions are being identified

Qualifications

  • Must have proven experience successfully leading event investigations, CAPA, and Root Cause Analysis (RCA)
  • Must have proficient knowledge in cGMP's and associated CMC regulatory considerations
  • Must have experience with commercial batch release activities
  • Some experience with network based applications such Trackwise and Oracle is preferred
  • You should have a B.S in a scientific or allied health field (or equivalent degree) and 3-6 years of relative work experience

OR

  • M.S (or equivalent degree) with 0-3 years of relevant work experience

Sthree US is acting as an Employment Business in relation to this vacancy.