Senior Associate - Quality Assurance - Document Control

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from Novo Nordisk’s acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world’s leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?

 

The Position

We are seeking a Quality Assurance - Sr. Associate who will manage and oversee the Document Control aspects of Quality Assurance and will assist with other QMS responsibilities. They must have a working knowledge of QMS and its responsibilities and be a self-starting problem solver who drives results through high compliance and a positive work style ensuring quality activities are carried out according to the regulatory requirements.

 

Relationships

Reports to Associate Director Product Quality.

 

Essential Functions

• Ensure quality activities are conducted according to the regulatory requirements.
• Drive Document Management System tasks to completion.
• Assist in the execution of other QMS responsibilities as needed (i.e., CAPA, Change Control, and Quality Events)
• Assist in facilitating and conducting trainings related to the electronic document management system in coordination with QA Training.
• Editing document for consistent formatting, error-free writing, and collaborating with content owners to ensure quality documentation. 
• Coordinate workflows with task owners to ensure that documents are carefully reviewed, issued, approved, and obsoleted within needed times within QMS electronic systems.
• Follow up with others to ensure that records are completed and documented within established times.
• Execute Administrative tasks for Veeva Quality Vault including but not limited to user provisioning and periodic system updates/maintenance.
• Be a self-starting problem solver who drives results through high compliance and a positive work style.
• Additional responsibility for execution and maintenance (data entry, metric reporting, filing, archival) of assigned quality system.
• Performs related duties as required.
• Be a self-starting problem solver who drives results through high compliance and a positive work style.

 

Physical Requirements

UP to 10% overnight travel required. Able to work flexible hours as required by the process.

 

Qualifications

• Bachelor’s degree required
• Minimum of 3 years of experience working in document management experience in a Quality Assurance related function
• Proficiency in intermediate MS Office concepts such as Word Styles, cross-references, keep with next, section breaks, freeze panes, header/footer, and others
• Ability to understand and apply regulations and guidance documents, and effectively communicate written and oral findings using critical thinking skills
• Strong organizational skills, with the ability to manage multiple tasks
• Preferred experience: 
  • Experience working in the pharmaceutical/biotech industry, or other regulated industry
  • Experience with Veeva Vault or other electronic document and quality management system is preferred
  • Knowledge of GLP, cGMP, GCP, Part 11 regulations, Data Integrity, FDA Guidance’s for Industry, EU regulations, and other standards.
  • Strong proofreading and document technical writing skills which must include processing of controlled documents (new documents, revision, obsolescence, etc.)
  • Strong problem solving/analytical skills
  • Ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
• Excellent written and verbal communication skills, strong organizational skills, strong negotiation, analytical and decision-making skills, and attention to detail

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

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