Senior Quality Assurance Associate

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.

This position will include working with Analytical and Process Development, Supply Chain and Materials Management, and Quality Control. The ability to work in a fast-paced, collaborative environment, while meeting timeline deliverables, is required. Competencies in the following areas: attention to communication; oral communication skills; technical writing skills; building collaborative relationships; thoroughness; ability to make decisions in a timely manner; adaptable to changes

Responsibilities:

  • Author and perform cross-functional review of SOPs for compliance and best-practice
  • Participate in CAPA, deviation, risk assessment and technical transfer teams
  • Support and participate in the document control program
  • Oversight of the change management program
  • Participate in internal audit activities
  • Conduct supplier qualifications
  • Support materials management in receipt and release of raw materials
  • Issue, review and release cellular product batch records
  • Assist with staff training and documentation

Required qualifications:

  • Bachelor’s degree in the life sciences (cell biology is desirable)
  • At least 4+ years’ experience in an FDA-regulated environment with GLP and GMP knowledge
  • Knowledge of applicable regulatory requirements
  • Strong documentation and coordination practices
  • 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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