Quality Assurance Specialist II/III (New Product Development/Transfer) (ADX-195-19)

POSITION SUMMARY

The Quality Assurance Specialist, reporting to a Quality Engineer, will support New Product Development and production transfer activities in an ISO 13485 and GMP-regulated environment. The individual must have a strong knowledge and application of the CFR and cGMP regulations to support the product launch.

RESPONSIBILITIES

• Provide direct QA support to the NPD technology transfer for the ArcherDX MRD assay components and processes.
• Review and approve batch records (Travelers) for product release.
• Assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
• Support the creation of Standard Work, Line Balance, Work Content, and other analytical tools, and work with production teams to implement
• Ensure the Quality System elements are in compliance with the regulations, and help to create and/or drive improvements in the creation of Standard Operating Procedures for the manufacture of the new product
• Collaborate across Development, Operations, and Manufacturing teams to support actions that help ensure production readiness for new products
• Provide QA support to create and maintain the production process in a validated state
• May support other Production-related activities including: raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, etc.
• Perform other duties as assigned by supervisor

QUALIFICATIONS

• 2+ years of experience within quality assurance in (life sciences) medical device.
• Experience with 21CFR820, cGMP, and ISO13485 regulations.
• Knowledgeable of New Product Development activities and technology transfer to production in a regulated laboratory or manufacturing environment
• Experience supporting and conducting process validations
• Lean/Six Sigma Certification preferred
• Attention to detail and ability to follow directions in modifying documentation
• Ability to interact and collaborate with multiple disciplines, and communicate clearly and effectively verbally and in writing
• Ability to work with minimal direction, and utilize good problem-solving skills
• Ability to multitask and work within a fast-paced dynamic team environment

EDUCATION:

• Bachelor’s Degree in a scientific field