Job Abstract

The Quality Assurance Specialist -Design Control will provide advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. This is a key position for any individual who enjoys working in a cross-functional environment. Activities include but are not limited to supporting the maintenance of Design History File, compiling Risk Management, and reviewing KPIs to assure effectiveness of the QMS.

Essential functions of the job include but are not limited to:

• Support the maintenance and review of DHF and actively participate in all Design Control activities pertaining to the CDx projects including risk management, acceptance of customer specifications, and change control.
• Lead Design Control with cross-functional teams such as Operations/ Research/ Project Management/ Regulatory Affairs/ IT.
• Assist in the QA review and acceptance of customer specifications to conform to contractual requirements.
• Assure product compliance to regulations, standards, and quality systems in accordance with CAP/CLIA, ISO9001, ISO13485, and ISO15189
• Proactively identify opportunities for improvements in areas of system compliance
• Serve as quality reviewer and approver for design control changes.
• Responsible in maintaining established companywide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events including:
  • Non-Conformances
  • Customer Complaints
  • Planned Deviations
  • Change Management
  • Corrective and Preventive Action (CAPA)
  • Audit Programs
• Participating on the Material Review Board
• Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities, as needed.
• Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews. Support due diligence as well.
• May be involved in the issuance of Certificates of Analysis for finished products and products for resale.
• Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services.
• Maintain filing and storage systems for document control, training, and batch records for raw and finished product.
• Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability.
• Provide Quality oversight for the Design Control, and Commercial stage, including Design Transfer.
• Responsible for Risk Management with DHFs.
• Create/revise/execute SOPs to support combination product quality governance in the commercial stage.
• Participate in quarterly and annual management review as well as periodic product reviews.
• Perform periodic review and update of DHF and RMF.
• Accountable for Design Control QMS processes.
• Provide guidance to junior level QA specialists.
• Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings
• Support validation activities, including review and approve validation protocols, reports, and final package documentation.
• Assist in the QA review and acceptance of customer specifications to conform to contractual requirements.
• Serve as SME during regulatory inspections

Qualifications:

Minimum Required:

• Bachelor’s Degree or equivalent combination of education and experience
• 4 years of related experience in a life science, regulated environment
• In-depth knowledge and hands-on experience with products designed and commercialized under ISO 13485, ISO14971, and 21CFR Part 820 standards
• Experience with IVDR, ISO15189, CAP/CLIA.

Other Required:

• Experience working in a Quality Department/Life Sciences-Regulated environment, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection
• Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
• Ability to meet deadlines and perform administrative functions
• Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function independently within a minimally supervised environment with exceptional attention to detail required
• Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
• Must be able to read, write, speak, fluently and comprehend the English language