Quality Assurance Associate (MA)

Job Description
Semma Therapeutics, a biotechnology company focused on developing an encapsulated stem cell-based cell therapy for Type 1 diabetes, is seeking an outstanding Quality Assurance associate to join its growing team. The role is located in Cambridge, MA and may require occasional weekend and/or evening work and some travel.

Responsibilities:

  • Monitor and assist with Quality Assurance activities including:
  • Issue documents (batch records, logbooks, SOPs)
  • Review and release of incoming raw materials
  • Monitor manufacturing processes and report observations to Senior Management for CAPA initiation and resolution
  • Review GMP and GLP reports and records for accuracy with reference to protocols, Quality Assurance Standards, Standard Operational Procedures
  • Track and maintain quality event reporting system
  • Assist in the implementation of Quality programs
  • Assist with document control
    Initiate and review of Standard Operating Procedures

Additional Responsibilities:

  • Participate in and follow-up on internal audits
  • Additional duties as assigned

Required qualifications:

  • Bachelor’s degree in the life sciences (especially cell biology)
  • At least 2 years’ experience in an FDA regulated environment, with GLP and GMP knowledge
  • Strong documentation and coordination practices. Detail-oriented and enjoy high work volume via computer
  • Strong interpersonal and communication skills
  • Experience in cellular therapy manufacturing is a plus

Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.

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