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Quality Control Specialist

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Thursday, June 29, 2023

Job Description

General Summary:

The Quality Control Specialist supports with a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.

Key Duties and Responsibilities:

  • Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs
  • Maintain accurate laboratory records and adhere to cGMP/GDP expectations
  • Participate in executing and/or review of method validations, method transfers and/or equipment qualification/requalification
  • Assist in troubleshooting of analytical methods and/or equipment as required
  • Participate in author and review of data, SOPs, COAs, analytical methods, protocols and reports
  • Participate in compliance related teams working towards the goal of continuous improvement
  • Report OOT/OOS results and other deviations to area management and help remediate issues
  • Perform other laboratory duties as assigned

Knowledge and Skills:

  • Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
  • Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
  • The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential
  • Strong attention to detail
  • Effective communication skills, both verbal and written

Education and Experience:

  • Bachelor's Degree in science or related discipline is required.
  • Typically requires 4+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at