GxP Operations Support Associate

Posted 5 Days Ago
Be an Early Applicant
United States of America
Entry level
Biotech • Pharmaceutical
The Role
The GxP Operations Support Associate supports documentation and electronic systems pertaining to manufacturing and quality control. Responsibilities include writing and editing SOPs, WIs, and batch records, along with managing workflow processes and supporting electronic systems like MES and LIMS.
Summary Generated by Built In

Job Description

General Summary:

The GxP Operations Support Associate 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, WIs, batch records, training content, and other related documentation, batch record, and support of MES, LIMS and electronic training. 

Key Duties and Responsibilities:

  • Writing, revising, and processing of workflows for batch records, SOPs, WIs and other documents for VMC operations
  • Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
  • Other duties and projects as assigned to meet departmental requirements

Knowledge and Skills:

  • Ability to stand for extended periods of time.
  • 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:

  • High School degree (or equivalent)
  • Typically requires 0- 2 years of experience

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 [email protected]

The Company
HQ: Boston, MA
5,000 Employees
Hybrid Workplace
Year Founded: 1989

What We Do

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases.

We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.

Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.

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