Connecting...

Senior Quality Assurance Operation Specialist

Sr. Quality Assurance Operations Specialist - Executed Batch Review/Gene Therapy Greater Boston Area Temp to Hire 60-65/hr

Are you a Quality Assurance Specialist supporting external operations? My client is looking for a candidate like you! I am collaborating with an industry leading Gene Therapy firm in the Cambridge, MA area looking to add TWO Quality Operation Specialist to their team on a temp to hire basis. The Quality Assurance group is an integral division within the company that will directly be supporting review of SOPs and Batch Reviews for their recently approved drug candidate that is slated to be released towards the end of this year.

Responsibilities

  • Supporting External Operations and Integrated Operations during batch production and testing
  • Review and Approve batch records in support of SOP, Validation Protocols and Reports
  • Assist in activities to assess and improve lot review and disposition
  • Review and approve deviations, CAPA ensuring effective root cause analyses and CAPA application
  • Signal quality issues and effectively, and proactively, resolve in a constructive manner
  • Support documents associated with deviations, investigations, OOS results and more

Requirements

  • BA/BS coupled with a minimum of 5+ years in Quality Assurance
  • Some familiarity with Cell Culture OR Upstream Manufacturing Beneficial
  • Expertise with Batch Record Review, Investigations, Deviations and CAPA development
  • Ability to contribute to a strong culture and offer new viewpoints while fostering relationship building communications
  • Experience working with Contract Manufacturing and Contract Testing Organizations, beneficial
  • Excellent organizational and project management skills
  • Ability to handle several tasks in an extremely fast-paced environment with changing priorities
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view

This is an urgent need with a start date slated to be two weeks after an acceptance of offer. If you, or someone you know, is interested in this role please apply OR forward an updated version of your resume to the attention of Ahmed Hassan and team at Real Staffing, Boston.

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