QA Specialist/Senior Specialist, External Quality Systems- Quality Assurance (Boulder)

Company: Dicerna Pharmaceuticals, Inc.
Location: Boulder
Posted on: June 19, 2022

Job Description:

The QA Specialist resides at our Boulder, CO site and will report to the Sr. Manager of Product Quality Assurance overseeing external manufacturing quality systems. This individual is integral to the successful delivery of GMP Product Quality Assurance initiatives and related systems.Key ResponsibilitiesWill be primarily responsible for the review, approval, and tracking of GMP clinical and commercial production deviation and change control records, while maintaining strong relationships with contract manufacturers to drive continuous improvement to their related quality systems and processes. This individual serves as a subject matter expert and trainer in this area and will provide coordination and communication of daily activities with the manufacturers and various internal Dicerna departments. This role will also support various other external and Dicerna quality systems related activities including, but not limited to, the following responsibilities:

• Receipt, tracking and archival of GMP production/QC laboratory deviations and change control records from contractors within Dicerna systems
• Track and maintain quarterly system performance metrics data for QA Management
• Maintain databases and systems used for tracking various GMP manufacturing associated support activities
• Administer and oversee internal system for review and approval of GMP production Master Batch Records
• Generation and/or revision of GMP documentation such as standard operating procedures, work instructions and forms
• Works closely with Regulatory, Supply Chain, Manufacturing and contractors to prioritize documentation review and approval in direct support of product release
• Continually monitor quality systems and procedures for improvement opportunities while ensuring compliance to applicable regulatory requirements and standards
• Maintain documentation and records to ensure GMP Quality standards and compliance
• Assist Sr. Manager in providing general QA support of all GMP product programs and clinical supply operations.
• May support Regulatory Authority inspection readiness as well as internal & external audits as needed
• May support other internal Dicerna GMP Quality teams in the areas of batch record review and Document Control activities as needed
• Provide QA support for internal systems managing shipment temperature excursions, product destruction and Supply Chain/Inventory/SAP processesRequirements
  • Minimum 5 years direct experience in a GMP Quality Assurance role. Alternatively, 5+ years of related GxP (GMP, GCP, GLP) industry experience or a BA/BS degree with Biology/Chemistry focus and minimum 3 years GxP industry experience
  • Experience in a virtual, contract manufacturing based GMP environment for chemical or biologics based drug substances, drug products and final dosage forms (injectables) is preferred
  • Demonstrated analytical and logic skills with a focus on fact-based decision making and problem-solving are essential
  • Direct experience with GMP production and QC testing deviation investigations (6M RCA, Product/Process Impact and Risk analysis and CAPA) strongly preferred
  • Experience with Veeva Vault or similar electronic document management system
  • Strong organizational skills, ability to multitask in a dynamic, fast paced environment
  • Strong collaboration and written /verbal communications skillsCompensation Expectations: $85,000 - $110,000

Keywords: Dicerna Pharmaceuticals, Inc., Boulder , QA Specialist/Senior Specialist, External Quality Systems- Quality Assurance (Boulder), Other , Boulder, Colorado