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Arbutus Biopharma

Quality Assurance Specialist

Quality – Warminster, Pennsylvania
Department Quality
Employment Type Regular Full-Time
Minimum Experience Experienced

At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape.  We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV. 

If you are looking to join a team with a proven track record in drug discovery and development and are as passionate as we are, we want to hear from you!

Role Summary:

The Quality Assurance Specialist is accountable to the Director of Quality and will be responsible for managing the document control process, the review of quality documentation as required for batch disposition, and supporting activities to ensure adherence to internal procedures and regulatory requirements.

Duties and responsibilities include:

  • Management of the document control system, including ensuring the revision of procedures to  reflect current practices and ensure applicable GXP compliance.  
  • Provide support to ensure Quality Assurance maintains an effective and compliant system for the disposition of products. This includes the review of manufacturing batch records, raw data and other documentation, as applicable.
  • Draft and revise product specifications.
  • Provide support for the non-conformance system, including acting as a liaison to ensure that investigations and CAPAs are completed on time.  
  • Support maintenance of the training system, including training of staff and keeping the training matrix current.
  • Conduct data quality audits of stability tables, regulatory submission documents and other documents as required.
  • Create and revise QMS SOPs.  
  • Provide support to the audit program, including maintenance of the Approved Vendor List.
  • Identify and support process optimizations activities.
  • Assist with additional activities, as needed.

 Requirements/Qualifications:

  • Bachelor’s degree in a Life Sciences discipline and at least 5 years of applicable experience in the pharmaceutical / biotech industry.
  • Strong knowledge of current GMP requirements. 
  • Proficient in Microsoft Outlook, Word, Excel and PowerPoint.
  • Prefer prior experience with SharePoint and working in an Electronic Document Management
  • System.
  • Excellent written and verbal communication skills. 
  • Ability to work independently and take initiative.
  • Ability to manage deadlines and prioritize effectively, while maintaining flexibility.

 

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  • Location
    Warminster, Pennsylvania
  • Department
    Quality
  • Employment Type
    Regular Full-Time
  • Minimum Experience
    Experienced
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