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Quality Assurance Specialist
2 months ago
Company Overview: ATS Automation
Position Title: Quality Assurance Specialist
Role Overview: This position is essential in supporting Project Managers in overseeing orders from a quality perspective throughout various project phases, including design evaluations, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and certain aspects of Performance Qualification (PQ) related to VPHP cycle development.
Key Responsibilities:
- Quality Support: Assist team members in drafting and finalizing technical documentation while interpreting and applying legal, regulatory, and project requirements.
- Field Collaboration: Engage with technical teams and third-party vendors at client locations to execute and complete SAT, IQ, OQ, VPHP cycle development, and VPHP PQ activities successfully.
- Quality Procedures Development: Collaborate with colleagues to establish and maintain quality protocols and controls at ATS facilities to meet customer and regulatory standards.
- Regulatory Compliance: Work alongside quality personnel and external parties to secure regulatory approval for ATS disposable kits.
- Inspection Methodologies: Create and implement inspection techniques to evaluate product quality.
- Production Conformity: Develop a systematic approach to ensure adherence and precision in the manufacturing process.
- Standards Compliance: Verify that products meet both company and international quality benchmarks.
- Technical Specifications: Ensure that products align with specified technical requirements and initiate corrective measures for any discrepancies.
- Documentation: Organize and document control activities and inspections.
Qualifications:
- Bachelor's degree or equivalent education in Quality Control, Engineering, Nuclear Medicine, or Microbiology.
- Technical or engineering experience is essential, with a strong preference for aseptic processing and containment expertise.
- Prior experience in a similar capacity is required.
- Familiarity with quality management systems and procedures.
- Understanding of methods to address non-conformities.
- Knowledge of regulations relevant to ATS products and certification processes.
- Ability to collaborate effectively with internal teams and clients under tight deadlines and high-pressure situations.
- Self-motivated, detail-oriented, consistent, and process-focused.
- Proficient in English, both written and spoken; proficiency in Italian is a plus.
- Excellent time management skills with the ability to coordinate multiple projects simultaneously.
- Proficient in Microsoft Office Suite, including Outlook, Project, Word, Excel, and PowerPoint.
- Must be eligible for domestic and international travel as required for the role.