Current jobs related to Associate Director, Quality Assurance - Chicago - Xeris Pharmaceuticals, Inc.
-
Chicago, Illinois, United States Borderless Capital Full timeJob Title: Director of Food Safety and Quality AssuranceWe are seeking a highly skilled and experienced Director of Food Safety and Quality Assurance to join our team at Borderless Capital. As a key member of our organization, you will be responsible for ensuring that our food products meet the highest standards of quality and safety.Key...
-
Chicago, Illinois, United States CookUnity Full timeJob Title: Director of Food Safety and Quality AssuranceCookUnity is a leading food delivery marketplace that connects talented chefs with consumers nationwide. As a Director of Food Safety and Quality Assurance, you will play a critical role in ensuring the quality and safety of our food products.Job SummaryWe are seeking a highly experienced and skilled...
-
Director of Quality Assurance and Testing
3 days ago
Chicago, Illinois, United States HUB International Full timeAbout UsHUB International is a global insurance and employee benefits broker with a strong presence in North America. We pride ourselves on empowering our clients and employees through innovative solutions and a collaborative work environment.Job DescriptionWe are seeking a highly experienced Director of Quality Assurance and Testing to lead our QA and...
-
Quality Assurance Director
7 days ago
Chicago, Illinois, United States HUB International Full timeAbout UsHUB International is a team of entrepreneurs who empower our clients by protecting businesses and individuals in our local communities.Our MissionWe help businesses evaluate their risks and develop solutions tailored to their needs.Key ResponsibilitiesLead the Quality Assurance and Testing teamDevelop and implement testing strategiesCollaborate with...
-
Quality Assurance Director
4 weeks ago
Chicago, Illinois, United States Nickerson Talent Solutions Full timeJob DescriptionJob Title: Quality Assurance ManagerCompany: Nickerson Talent SolutionsJob Type: Full-timeIndustry: Industrial Parts ManufacturerLocation: Remote (with occasional travel)About Us: Nickerson Talent Solutions is a leading provider of talent acquisition and management services. We are seeking a highly skilled Quality Assurance Manager to join our...
-
Director, Quality Assurance
4 weeks ago
Chicago, Illinois, United States OCC Full timeAbout the RoleThe Director, Quality Assurance will lead multiple teams in support of development testing on OCC's Ovation clearing applications. This role will be responsible for process definition and refinement, coordinating a holistic approach to implementation of automated testing solutions to ensure high quality of software deliverables, coordination of...
-
Quality Assurance Supervisor
2 months ago
Chicago, United States National Safety Apparel Full timeJob DescriptionJob DescriptionReports To: Director of ManufacturingDirect Reports: NoneFLSA Status: Non-exempt (Eligible for OT)Employment Type: Full timePosition Overview: To complete various inspection and verification related tasks, such as: conducting audits, investigations, inspection, and filing reports related to the tasks. The goal is to identify,...
-
Quality Assurance Supervisor
7 days ago
Chicago, United States National Safety Apparel Full timeJob DescriptionJob DescriptionReports To: Director of ManufacturingDirect Reports: NoneFLSA Status: Non-exempt (Eligible for OT)Employment Type: Full timePosition Overview: To complete various inspection and verification related tasks, such as: conducting audits, investigations, inspection, and filing reports related to the tasks. The goal is to identify,...
-
Director of Quality Assurance
1 week ago
Chicago, Illinois, United States OCC Full timeAbout the RoleThe Director of Quality Assurance will lead multiple teams in support of development testing on OCC's Ovation clearing applications. This role requires a mix of business and technology knowledge with the ability to liaise between functions to support functional validation of delivered software against requirements.Key ResponsibilitiesDirects...
-
Associate Quality Assurance Analyst
4 weeks ago
Chicago, United States Uline Full timeAssociate Quality Assurance Analyst Corporate Headquarters 12575 Uline Drive, Pleasant Prairie, WI 53158 Its all about our customers! We put a lot of heart into making Uline.com easy to navigate and place orders. As an Associate Quality Assurance Analyst on our eCommerce team, put our site to the test to ensure an exceptional online shopping experience....
-
Quality Assurance Administrator
4 months ago
Chicago, United States SAFER FOUNDATION Full timeJob DescriptionJob DescriptionThe Safer Foundation is a social service provider to individuals with arrest and conviction records. Through a full range of services, including case management, educational instruction and advocacy, we focus on preparing individuals for the world of work by helping them find and keep productive and meaningful employment.General...
-
Quality Assurance Administrator
7 days ago
Chicago, United States SAFER FOUNDATION Full timeJob DescriptionJob DescriptionThe Safer Foundation is a social service provider to individuals with arrest and conviction records. Through a full range of services, including case management, educational instruction and advocacy, we focus on preparing individuals for the world of work by helping them find and keep productive and meaningful employment.General...
-
Quality Assurance Supervisor
1 week ago
Chicago, Illinois, United States The Judge Group Full timeAssociate Quality Assurance SupervisorWe are seeking a highly skilled Associate Quality Assurance Supervisor to join our team at The Judge Group. As a key member of our quality assurance team, you will be responsible for leading, directing, and training employees to achieve quality standards.Key Responsibilities:Manage product quality and ensure compliance...
-
Director of Quality Assurance and Testing
4 days ago
Chicago, Illinois, United States HUB International Full timeAbout UsHUB International is a global insurance and employee benefits broker that empowers its clients and employees through innovative solutions and technology. Our team of entrepreneurs believes in protecting businesses and individuals in local communities, evaluating risks, and developing tailored solutions. We foster a culture of empowerment, providing...
-
Quality Assurance Associate
4 weeks ago
Chicago, United States Tackle Ai Full timeFull-Time Position Mon - Fri $20-22/Hour Summary: The Data Labeling Associate will work with Machine Learning Engineers to gather and analyze unstructured documents and data sets. The position identifies crucial information within the data to annotate text and images that will be used to train machine learning models. The individual is responsible for...
-
Quality Assurance Manager
2 weeks ago
Chicago, Illinois, United States The Judge Group Full timeQuality Assurance Supervisor Job DescriptionWe are seeking a highly skilled Quality Assurance Supervisor to join our team at The Judge Group. As a Quality Assurance Supervisor, you will play a critical role in ensuring the quality and safety of our products.Responsibilities:Collaborate with the FSQA Manager to develop and implement quality assurance and food...
-
Quality Assurance Specialist
2 days ago
Chicago, Illinois, United States Kelly Science, Engineering, Technology & Telecom Full timeQuality Assurance Associate Job DescriptionWe are seeking a detail-oriented Quality Assurance Associate to join our specialty lab team in Gurnee, IL. This full-time position offers a comprehensive benefits package, including medical, dental, 401K, paid time off, and eligibility for annual performance reviews.Key Responsibilities:Quality Documentation: Draft...
-
Quality Assurance Coordinator
1 week ago
Chicago, Illinois, United States Thresholds Full timeQuality Assurance CoordinatorThresholds is seeking a highly skilled Quality Assurance Coordinator to join our team. As a Quality Assurance Coordinator, you will play a critical role in ensuring the highest standards of quality in our services. Your expertise will help us maintain our commitment to excellence and drive continuous improvement in our...
-
Quality Assurance Manager
3 weeks ago
Chicago, Illinois, United States The Judge Group Full timeJob Summary:The Judge Group is seeking a highly skilled and experienced Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for directing and managing quality assurance and food safety systems, ensuring compliance with regulatory agencies, customers, and third-party auditing companies.Key...
-
Quality Assurance Manager
4 weeks ago
Chicago, Illinois, United States John Hofmeister & Son Full timeJob SummaryWe are seeking a highly skilled Quality Control Supervisor to join our team at John Hofmeister & Son, Inc. The successful candidate will be responsible for directing and managing quality assurance and food safety systems, ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesQuality Assurance and Food Safety:...
Associate Director, Quality Assurance
4 months ago
Overview:
The Associate Director, Quality Assurance will provide cross functional quality assurance support to manufacturing, quality control, clinical and non-clinical operations. This role will be responsible for QA business processes supporting GMP, GCP and GLP compliance, regulatory inspection readiness, quality planning and continuous improvement projects and will provide leadership and direction to the QA team and operational colleagues on quality matters. The Associate Director, Quality Assurance will act as an internal consultant to operational counterparts providing QA support and guidance for clinical, non-clinical, manufacturing, and pharmaceutical development operations representing QA on project teams and discussions. This role will be directly involved with quality processes including, but not limited to, change control, deviations and investigations, internal audit, supplier qualification and audit, batch review and annual product review.
Responsibilities:- Review and/or approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, investigations, change controls, procedures, annual product reviews, validation documentation, Quality Agreements, clinical study documents.
- Responsible for the escalation of critical quality issues as appropriate to Quality Management
- Provide technical leadership and advice for key Quality issues and initiatives.
- Identify, prioritize, and support the implementation of continuous improvement initiatives, to maintain compliance while striving to meet business and customer needs.
- Maintain a continued state of GXP compliance and readiness for partner audits, Pre-Approval Inspections (PAIs), Bioresearch Monitoring Program (BIMO) and Routine GMP Inspections by regulatory agencies at Xeris facilities and contract facilities.
- Manage Pre-approval Inspection Readiness at Xeris and at contract organizations.
- Work with the Regulatory Affairs and Quality department to support Heath Authority Inspections.
- Promote continued alignment in quality business processes across the organization.
- Develop, improve and implement the systems and processed needed to operate at the required level of quality and efficiency leveraging existing company knowledge and practices where necessary, but also incorporating external experiences and learning.
- Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.
- Support project teams as they deliver products, projects and programs, by providing upfront input, feedback and support on decisions & strategies. Collaborate with project teams to ensure the right decisions are made to meet project deliverables, strategic goals and quality and compliance expectations.
- Contribute to the Global SQM processes with an immediate focus on global suppliers including supporting supplier identification and selection; supplier evaluation and approval; supplier quality agreements; supplier performance monitoring and supplier relationship management.
- Coordinate and participate in/lead supplier/ vendor and clinical investigator site audits.
- Provide reporting of requested quality metrics to the Quality Management Review Chair.
- Participate in review of manufacturing and testing of new products to ensure quality compliance, and that all products meet or exceed customer requirements.
- Provide clinical quality oversite to studies and provide quality insights and support as needed.
- Other duties as assigned by the Sr. Director of Quality.
- A minimum of a bachelor's degree required in Engineering, Sciences or other related fields.
- Minimum of 8+ years in quality, compliance, and pharmaceutical quality management, including GXP facility audits, in a regulatory environment (FDA, MHRA, Notified Body, etc) required.
- Experience with regulatory inspections.
- Excellent working knowledge of GMP/GCP/GLP regulations and sources of regulatory information (FDA, EU GMP, ICH, PIC/s etc.)
- Competencies: Analytical Skills, Strong decision-making Skills, Adaptability, Teamwork & Collaboration, Organizational skills, Problem Solving, Written and Verbal Communications, Attention to Detail
Working Conditions
- This position is a hybrid role located in Xeris Chicago office. A minimum of three days per week in the office is required. On site requirements may change at managements discretion.
- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
- Some of the work performed is in a typical office environment and includes long periods of sitting at a desk as well as frequent usage of hands and computer.
- This position does require moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting, and twisting.
- Employee may be required to exert up to 25 pounds of force occasionally.
- Travel up to 25 40%.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
