Ensure your work experience focuses on achievements, rather than responsibilities. IntelGenx Corp. Saint-Laurent, QC. Provided training to plant quality and operations teams on relevant topics: GMPs, SOPs, SSOPs, HACCP. Providing coaching to cross-functional teams on the complaints system, investigation techniques, root cause analysis and development of corrective and preventive action plans. To get that QA job, submit a flawless QA resume. Headline : Site Quality Assurance Manager with 5 years of experience in Quality Assurance inspections that consistently exceed customer standards and specifications. Quality Assurance Lead Resume Examples & Samples Define an effective controls framework Implement front to back controls through the end to end CCAR processes across multiple business functions, including data quality controls, reconciliations, process controls, results analysis and challenge processes, and approvals. Collaborated to ensure the success of pre-approval inspections at production facilities. It appears on 15.3% of resumes. Quality assurance managers strive to establish quality standards and procedures and also monitor constantly that the produced goods/service meet the agreed targets. In addition to above duties, now providing interim duties as Site QA Leader overseeing the daily activities of 10 QA personnel ( Pharma, Medical Devices and API) Providing on site direction for site QMS to ensure compliance with cGMP, QSR, ISO, CMDR, MHRA and JPAL for terminally sterilized and aseptically filled small volume parenterals and sterile medical devices (diagnostic and therapeutic) Direction of all Quality Assurance functions for US Healthcare Manufacturing (Quality Systems Compliance for Sterile Drugs, Devices, API and Contract Manufacturing) Effectively lead FDA GMP, ISO, CMDR, MDD, AIMDD Compliance Inspections Supported critical product development and process improvement projects impacting IND, NDA, CBE, Pre-approvals, 510K, PMA, CE, CMDR and Annual Report Successfully implemented and directed the improvements to key quality systems (Change Management, CAPA-Deviation, Document Control, Vendor Management, Training) - resulting in real time monitoring of quality information from all processes, work operations, concessions, quality audits, quality records, complaints, returned product, nonconforming product, material attribute defects, root causes and corrective/preventive actions. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience, Strong understanding of regulatory requirements for commercial products, Proven track record with FDA, EMEA and other Health Authorities, Strong Technical understanding of pharmaceutical processes, Team and consensus builder, with definitive and authoritative decision making ability, Ten or more years of experience in an applicable risk management environment, At least ten years of experience in quality control, quality assurance, compliance testing or audit roles for financial services company, Internal and external audit experience in banking industry, Ability to identify and clearly communicate issues, measurement criteria, cause, exposure and recommendations, Advanced to Expert level of presentation (verbal/written), relationship building and persuasion skills, Advanced to Expert understanding of Consumer Banking operations, products/services, systems and associated risks/controls, Advanced to Expert understanding of applicable laws, regulations, financial services and regulatory trends that impact consumers, Comfortable working in a team environment with layers of required review/approval, Prior leadership of staff that perform testing/monitoring activities, Bachelors degree in Computer Science, Computer or Software Engineering, or a related field and 5+ years of experience as a manager of high performance quality assurance teams, focused on Wireless Connectivity, 10+ years of industry experience, including at least 3+ years of hands-on testing or test automation and 5+ years as a quality assurance manager, Experience implementing and testing networking and wireless communications protocols; performing distributed systems design and testing; experience with Bluetooth, Wi-Fi and/or ZigBee including understanding of the air interface and MAC layer interactions, Strong experience managing and creating test automation frameworks, Quality Assurance best practices pertaining to test definition, requirements tracking, and test automation, Masters degree in Computer Science, Computer or Software Engineering, with strong industry knowledge of testing Wireless Connectivity in mobile consumer electronics devices, Strong Experience with testing wireless protocols (Wi-Fi, BT/BLE, ZigBee and/or LTE/UMTS), Manage, staff, and lead a team of Quality Analysts focused on data warehousing, business intelligence, and Java applications, Maintain and implement quality assurance standards within our different Scrum teams, Participate in QA Analyst work to keep up-to-date skillsets and firsthand views on the issues, challenges, and best practices of each team - This person will need to be comfortable with rolling their sleeves up and getting stuck in with their team, Coordinate with appropriate parties to identify and prioritize next steps throughout the incident management process, Effectively advocate and disseminate Quality Assurance best practices in the team, This person will need to be comfortable with rolling their sleeves up and getting stuck in with their team, Extensive experience in software quality assurance on Enterprise Data Warehousing and Business Intelligence projects, Experience with Data Warehousing using the following technologies, Previous experience developing custom Java applications using, Direct responsibility for the corporate quality function, including quality engineering, and the corporate quality management system and tools, Indirect responsibility for site quality organizations across the company, Ensure compliance with national and international quality standards, Define and implement quality procedures in conjunction with operating staff, Support site internal and external compliance audits and drive necessary corrective action completion, Bachelor's Degree in applied science or engineering field, Minimum 5-years prior experience in Quality, Engineering or Operations Management, Demonstrated experience working with manufacturing, engineering and supply chain, Demonstrated exceptional written and oral communication skills, Proven track record of delivering results against objectives, Willingness and ability to travel, as required (up to 25% anticipated), Direct, manage and coordinate the GMP-QA team in the development, implementation, maintenance and improvement of the GMP Quality Systems, Provide day-to-day direction, support and leadership to the GMP QA associates, ensuring that the team has adequate resources and support to meet its responsibilities, Provide performance feedback and management of direct and indirect reports, Provide leadership and direction to the QA team in the absence of the QA Director, Lead and collaborate with the management team of the logistics/distribution department and of other functional areas to review key quality metrics and establish quality improvement initiatives, QC inspection and QA review of logs, products and records, Foreign site quality & GMP compliance review (for imported products), Coordination of PV activities to designated PV parties (for imported products), Maintenance and timely submissions of various regulatory GMP license amendments and renewals (DEL, MDEL, NHP-SL and OCS-LD), Creation and review of Quality Agreements with MAHs/clients and vendors/suppliers, Facility and equipment qualification/validations, Internal audits/self-inspections on GMP facilities and processes to ensure compliance with GMP, client requirements and Innomar procedures, Management of controlled documents (Policies/SOPs/WIs/Forms) request, review and issuance work flow by actively liaising with department management and other reviewers/approvers, Ensure facility and process audits as well as vendor audits are scheduled in advance and reflected in the QA audit calendar, Coordinate and host external audits by clients and/or regulatory agencies, Coordinate audit preparation activities with all impacted business units, Facilitate appropriate, effective and timely provision of documents, responses and actions during the audit, Collate responses and corrective actions with relevant impacted business units to ensure timely resolution of observations and issuance of documented responses, Provide summary and trend analyses on outcome of external audits to senior QA and functional department management, Interact with clients, internal stakeholders, vendors and various project members to ensure that specified business needs are met; assists in the post-implementation analysis to ensure that requirements are fulfilled, Manage the CAPA process for the distribution/logistics department by ensuring that non-conformance and other reportable events as well as CAPA reports are recorded, followed-up, tracked and trended, Identify, monitor and present internal/external audit and CAPA trends to department and QA management teams, Implement continual process improvements related to GMP, warehouse, distribution and regulatory processes as required, Timely submission of billing invoices to Finance for all billable QA/QC activities, Provide quality metrics for assigned areas to the QA Director on a monthly basis and on an ad-hoc basis as requested, Provide guidance to clients and internal stakeholders on GMP matters and serve as a resource to internal stakeholders for the interpretation and application of regulations and applicable guidelines, In coordination with the QA Director, prepare QA budget and manage departmental expenses, Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required, May also be assigned other duties and tasks as required from time to time by the QA Director, Minimum Bachelors of Science degree in chemistry, pharmacy, pharmacology or other related healthcare or pharmaceutical field, Minimum of 15 years experience in a senior Quality Assurance function in the pharmaceutical GMP or biotechnology industry, Minimum of 10 years experience in management of multiple projects (planning, implementation, management and monitoring) including budget, resource plan, Key Performance Indicators, etc, Minimum of 5 years experience each in the following areas, Performing/overseeing facility, process and equipment qualification/validation, Conducting internal self-inspections and vendor audits, Submission and maintenance of Health Canada facility licenses, Product quality review and Canadian QA release of imported products, Industry certification in Quality is preferred. Organized meetings with suppliers to obtain cause and corrective actions reports as applicable. Watched over, from the reception of raw material, until the shipping of our materials in order our products as processes comply with the rules of reference ISO:9001 and BRC, as well as with the regulations and food law. Performed audits on clinical study reconciliations, and reviewed/approved equipment cleaning verification proposals. Summary : Regional food safety and quality assurance manager with 7 years of food safety and quality experience. Responsible for the quality management systems and QA personnel at eight Wabtec global services field locations in the U.S. Trained new and less experienced staff in the preparation of sanwiches and in company policies and procedures. Developed and reported dept. Organized, maintained and executed packaging batch records and supportive documentation required for the final release of finished products to be distributed. 2022, Bold Limited. Hired full time as Emergency Room technician while floating to ICU and cardiac monitors. Recruiters and hiring managers suggest fitting your resume on one page. Advanced Job Search. Quality assurance: 5 years (required). This includes budgeting/capitalization of the department and providing career development counsel to direct reports and other QA professionals, Provide technical support to plant management regarding process/product improvements including key financial input regarding butterfat and solids yields, Develops and implements a plant manufacturing assessment process that accurately measures the execution of the Land O' Lakes QMS, Develop programs and monitoring systems with site sanitarian to effectively manage the sanitation practices within the plant, We are seeking an individual with a BS/BA degree in Food Science or related technical field with proven leadership skills and experience managing people including employee development, The individual should have minimum of ten (10) years experience in quality assurance, operations and regulatory responsibilities, Experience will include the development and implementation of quality assurance programs for high risk products such as ready-to-eat foods, dairy, cooked meats, etc, Proven experience in the highly regulated environments of IMS, USDA and wastewater control, Proficient with the concepts of hazard analysis, risk assessments, and system/process applications, Knowledgeable in quality management techniques of root cause analysis, FME and preventative quality, Manages the Quality Assurance Department for Facilities and oversees quality programs at Chicago Public Schools that include quality engineering, custodial, supplier programs, and statistical process control, Design, input, prepare, and maintain the quality assurance program in support of initiatives, Responsible for participating in audit reviews in the various facilities, Continuously refine QA objectives, fine tune QA reports and Facilities-wide metrics, Oversees supplier investigations and supplier performance, Deliver weekly quality assurance and continuous process improvement status reports, Attend internal and external meetings, providing regular updates on quality assurance and continuous process improvement issues and concerns, Draft correspondence, gather data, document process maps, and draft presentations, Makes regular contact with vendors to keep abreast of quality issues and to resolve quality problems, Develops action plans to maintain and improve product quality and principal satisfaction, Initiates investigations of quality concerns, determine corrective actions to be taken and implements corrective actions, Recommends, interprets and enforces quality policies and practices, Assists in the development of policies and procedures, Promotes an associate relations environment that is consistent with long term management objectives, Plans, organizes and allocates the departments resources to meet department and company goals, Serves as a member of various committees as needed, 4 year degree in quality, engineering, business management or an equivalent field. 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