Job Closed
This listing is no longer active.
The World Leader In Serving Science
QA Auditor II – Vendor Auditor
Location
China
Posted
26 days ago
Salary
0
Seniority
Senior
Job Description
QA Auditor II – Vendor Auditor
Thermo Fisher Scientific
• Conduct and/or lead a variety of GxP qualification and routine vendor audits • Perform directed vendor audits • Provide GxP consultation and support to internal and external clients • Prepare and present audit findings and/or other related information at meetings
Job Requirements
- Bachelor's degree or equivalent
- Previous QA and GxP vendor auditing experience (comparable to 3+ years)
- Solid knowledge of the clinical trial process
- Thorough knowledge of GxP and appropriate regional research regulations and guidelines
- Excellent oral and written communication skills
- Strong attention to detail
- Problem solving, risk assessment and impact analysis abilities
- Strong organizational and time management skills including flexibility
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Related Guides
Related Categories
Related Job Pages
More QA Engineer Jobs
Role Description As a Lead Test Engineer (Consultant) in Kainos, you’ll be a technical leader and innovator in software testing, providing strong test leadership and direction within a multi-skilled agile team. Your responsibilities include: - Taking responsibility for the strategy, design, and development of automated, manual, and non-functional tests. - Helping the team deliver working application software that meets user needs and is of sufficient quality for promotion to users. - Making sound, reasoned decisions in a fast-paced environment. - Managing, coaching, and developing a small number of staff, focusing on employee performance and career development. - Providing direction and leadership for your team while solving challenging problems together. - Interacting with customers, sharing knowledge, and mentoring those around you. Qualifications - Experience of ensuring testing layers have adequate coverage in line with software testing principles and practices. - Expertise in designing, creating, and maintaining test scripts and test approaches, including manual and automated testing across all layers of an application including non-functional test coverage. - Experience using Test Automation open-source technologies (e.g. Selenium, JUnit, TestNG, Cucumber, Cypress, Playwright) and configuring tools for testing such as Jenkins and/or TeamCity within a continuous integration environment. - Practical knowledge of at least one object-oriented programming language (e.g. Java). - A high level of technical awareness and a sound understanding of software architectures. - Experience in managing others, setting objectives, giving feedback, and leading performance reviews. - Passionate technologist, keen to expand knowledge of the latest QA tools, tech, and methodologies. Requirements - Operating within a Test Lead role (or similar) on a medium-large sized Agile project. - Demonstrable experience of effective stakeholder management and commercial awareness. Benefits - We are committed to building a diverse team where everyone is valued, respected, and given an equal chance to thrive. - Support from our friendly talent acquisition team throughout the recruitment process. - Accommodations or adjustments available upon request to tailor the recruitment process to individual needs.
Senior Food Safety Quality & Regulatory Affairs Specialist
Conagra BrandsConagra Brands has the most impactful, energized and inclusive culture in food.
Role Description Reporting to the Manager, Food Safety Quality & Regulatory Affairs, you will independently implement programs within assigned areas of food safety, quality, and regulatory affairs under limited supervision. You will support the execution of processes, procedures, and daily activities that ensure product safety, regulatory compliance, and continuous improvement across the organization. - Gather, analyze, and interpret data to identify trends and issues, providing input to decisions related to product safety and quality within assigned areas of responsibility. - Provide technical guidance and oversight to employees within assigned technical areas and support knowledge development across the organization. - Support management in the design, implementation, and improvement of processes and procedures within assigned technical areas. - Deliver food safety and quality training programs to assigned facilities. - Provide technical, analytical, and decision-making support when managing quality and food safety issues. - Conduct quality and food safety audits independently or as part of a team at manufacturing locations. - Collaborate with cross-functional partners to ensure food safety, quality, and regulatory compliance of company products. - Evaluate the effectiveness of food safety and quality programs and recommend adjustments to support continuous improvement. - Execute inspection criteria to assess compliance with internal standards and regulatory requirements. - Participate on cross-functional teams to support effective implementation of quality assurance initiatives and supplier process improvements. - Perform assigned technical tasks in alignment with departmental processes and procedures. - Support confirmation that Food Safety Plans based on Hazard Analysis and Critical Control Points principles remain current, relevant, and effectively executed to meet company standards and regulatory requirements. - Partner with functions outside of Food Safety, Quality & Regulatory Affairs to drive efficiencies and effectiveness in food safety and quality practices. Qualifications - Bachelor’s degree in Food Science, Biological Science, Chemical Science, or a related field. - Minimum of five years of food industry experience. - Knowledge of food safety systems, food manufacturing processes, and related technologies. - Knowledge of Global Food Safety Initiative benchmarked schemes, including Safe Quality Food and British Retail Consortium standards. - Knowledge of Good Manufacturing Practices, sanitation, pest control, allergen management, training programs, and food safety systems. - Knowledge of regulatory requirements and frameworks, including the Food Safety Modernization Act, Food and Drug Administration, and United States Department of Agriculture requirements. - Strong troubleshooting, data analysis, investigative, report writing, interpersonal, and communication skills. - Demonstrated strength in setting a positive example and supporting others. - Travel requirements range from approximately 25 percent to 75 percent based on business needs. - Must be able to travel independently and as a responsible Conagra representative, including driving a company or rental vehicle as needed. Physical Requirements - You may be required to walk around the facility, climb stairs/ladders, kneel, or perform repetitive tasks that require hand-eye coordination. - You may be required to lift or carry materials that can vary in weight and size. - This is a manufacturing environment with large, moving equipment. Noise levels can be high, and temperatures may vary. Compensation Annual Base Salary: $81,000.00 - $100,000.00 The annual salary listed above is the expected offering for this position. An employee’s actual annual salary will be based on but not limited to: location, relevant experience/level and skillset, while balancing internal Conagra employees’ equity. Conagra Brands will comply with applicable law regarding minimum salaries for exempt employees. Benefits - Health: Comprehensive healthcare plans, wellness incentive program, mental wellbeing support and fitness reimbursement. - Wealth: Great pay, bonus incentive opportunity, matching 401(k) and stock purchase plan. - Growth: Career development opportunities, employee resource groups, on-demand learning and tuition reimbursement. - Balance: Paid-time off, parental leave, flexible work-schedules (subject to your location and role) and volunteer opportunities.
Senior Quality Engineer
Tempus AITempus is advancing data-driven precision medicine with the practical application of AI in healthcare. It’s About Time.
Role Description As a Senior Quality Engineer, you will: - Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s). - Lead risk assessments to determine testing strategies. - Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry. - Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements. Responsibilities: - Support regulatory compliance of the host system operating with Tempus Medical Device(s). - Develop and maintain CSV policies, procedures, templates and work instructions. - Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities. - Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software. - Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports. - Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution. - Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement. - Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits. - Provide CSV guidance, coaching, mentorship, and training to test engineers within the team. Qualifications - BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. - 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech). - 3+ years experience in Computer System Validation (CSV). - Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006). - Knowledge of quality system principles, practices, and standards for the life science industry. - Ability to deliver quality outputs without directions or under minimal supervision. Requirements - CHI: $75,000-$100,000 - The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Benefits - Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. Company Description We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Role Description - Conducts supplier qualification / certification, assessment, monitoring, escape management, and quality issue resolution processes. - Analyzes and makes recommendations on quality data and the development of part / supplier specific quality issue resolution and corrective actions. - Provides research on and explanations of root cause analysis & problem solving (Red-X & 8D) in escape management procedures. Develops corrective and / or preventive actions for systemic process and product design problems for product provided by suppliers. - Conducts processes and procedures for supplier qualification / certification, source inspection and material release processes, and Correction Action Boards / DQ Clinics with suppliers. - Drives support for the UTC Supplier Gold program to ensure healthy continuous improvement and sustainability. - Reviews processes and metrics and makes recommendations to ensure supplier is capable to meet all requirements for work transfer and process change management including Resourcing Gate and Production Part Approval Process (PPAP) acceptance. Qualifications - Typically requires a University Degree and minimum 5 years prior relevant experience or an Advanced Degree in a related field. - 6+ years professional experience in a supply chain operations environment (monitoring, auditing, developing suppliers/operations) or equivalent. - Strong background in machining. - Strong verbal and written communication skills and the ability to speak effectively and easily with both internal and external executives and employees. - Ability to adapt and use multiple forms of interaction styles to convince and/or persuade people/stakeholders to follow ideas and proposals. - Ability to use flexible and adaptable working styles to build and develop effective cross-functional teamwork. - Ability to travel up to 50%. Requirements - Knowledge of Quality Regulations, Quality Core Tools Knowledge, Advanced Product Quality Planning (APQP), Practical Problem Solving, International Management system standards, Authorities / Regulations / Standards. - Knowledge of QMS, Auditing/Assessing, Risk Management / Continuous Improvement (Lean Six Sigma). Benefits - Medical, dental, and vision insurance. - Three weeks of vacation for newly hired employees. - Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option. - Tuition reimbursement program. - Student Loan Repayment Program. - Life insurance and disability coverage. - Optional coverages you can buy: pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection. - Birth, adoption, parental leave benefits. - Ovia Health, fertility, and family planning. - Adoption Assistance. - Autism Benefit. - Employee Assistance Plan, including up to 10 free counseling sessions. - Healthy You Incentives, wellness rewards program. - Doctor on Demand, virtual doctor visits. - Bright Horizons, child and elder care services. - Teladoc Medical Experts, second opinion program. - And more!




