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Quality Assurance Specialist Co-Op

Department: 110 CMC

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary

This position provides an opportunity for a highly motivated and tenacious student who is currently pursuing a degree in Quality Management, Biology, Chemistry, Regulatory Affairs, or Pharmacy degree to get hands on experience working with a Quality team in an innovative,  fast-paced clinical stage biotech company.

This Co-Op will provide proactive compliance support across regulated GXPs (GMP, GCP/GLP). Additionally, they will contribute to key development projects and help advance the overall maturity of the Quality System.

This role is based in Waltham, MA without the possibility of being a remote role. This role will be for a 6 month period beginning in January 2023.

Key Responsibilities of the Role:

  • Learn about current drug regulatory and clinical trial requirements, and the Management System by assisting in multiple projects including:
  • The development of a Quality intranet blog/posts.
  • Clinical trial Quality team support including development of Clinical Endpoint Tools
  • Assist Document Control and Record Retention
    • Assist with editing, formatting, and drafting of GXP controlled documents
    • Track document activity to ensure timeliness and process efficiency
    • Oversee uploads of records into the electronic document management system, (EDMS)
    • Create an EDMS Glossary
    • Maintain records submitted for archival
    • Create DocuSign Part 11 user accounts
  • GXP Training Program
    • Update, organize employee training files
    • Create and deactivate user accounts in the electronic learning management system (LMS) ComplianceWire
    • Scan records and creates electronic training files
    • Assist to create and maintain departmental role-based training curriculum and maps per department
    • Schedule onboarding training for new hires and consultants
    • Assist to develop GXP training material
    • Monitor training completion
  • GXP Audit Program
    • Train in the conduct of GXP audits (non-travel)
    • Update electronic audit trackers and assist in tracking and managing Audit Documentation
    • Assist in sending out questionnaires and setting up Vendor and Clinical Site audits
    • Standardize Vendor questionnaires and Audit Templates
    • Keep up to date Vendor Qualification and Audit Schedules and Trackers

Education and Experience Requirements:

  • Currently enrolled as a student working towards a bachelor’s degree in Quality Management, Biology, Chemistry, Regulatory Affairs or Pharmacy
  • At least 2 years of study in one of the above scientific fields preferred
  • Basic familiarity with pharmaceutical regulations (GMP, GCP, GLP) is a strong plus
  • Must possess excellent organization skills and ability to manage multiple priorities
  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
  • Willingness to learn, be mentored, and improve
  • Ability to work independently and also a highly collaborative team player who enjoys open communication
  • Ability to work in a fast-paced demanding environment
  • Ability to prioritize based on shifting demands
  • Ability to work independently, prioritize, multitask, know when to ask for help
  • Knowledge of document formatting/word processing
  • Demonstrated ability in managing tracking databases and logs
  • Internal customer service/people skills are required
  • Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
  • Proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments
  • Proficient in Excel, PowerPoint, Adobe Acrobat, Smartsheet and generally technical savvy

#LI-Onsite

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.


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