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GxP Operations Support Specialist

Semma Therapeutics

Semma Therapeutics

Customer Service, Operations
Boston, MA, USA
Posted on Wednesday, July 10, 2024

Job Description

The Specialist will be responsible for supporting documentation and electronic systems related to manufacturing and quality control at the Vertex Manufacturing Center (VMC). This includes writing and editing of SOPs, work instructions (WIs), batch records, training content, and other related documentation. This role will also review batch records, analytical data, and support of Manufacturing Execution System (MES), LIMS and electronic training.

Responsibilities:

  • Writing, revising, and processing of workflows for batch records, SOPs, WIs and other documents for VMC operations
  • Creating training content and training of personnel for specific functions
  • Investigations, CAPAs, and other QMS record management as needed
  • Analytical data and/or batch record review
  • Implementation and optimization of electronic systems such as LIMS, MES, and electronic WIs
  • Writing and revising documentation for manufacturing equipment including procedures and assessments

Knowledge and Skills:

  • Ability to stand for extended periods of time.
  • Knowledge of CGMP requirements for manufacturing.
  • Solid organizational, interpersonal, communication, and documentation skills.
  • Ability to follow written and oral instructions in English.
  • Basic computer skills and ability to learn new systems.
  • Experience with Microsoft Office Suite

Education and Experience:

  • Bachelor’s degree with a minimum of 1+ years of experience in a pharmaceutical or biotechnology manufacturing or quality control environment.
  • The equivalent combination of education and experience in a related field will also be considered.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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 ApplicationAssistance@vrtx.com