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
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