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QA Auditor-logo
QA Auditor
CSL GlobalEMEA, DE
Für die Abteilung Qualitätssicherung CSL Plasma in Göttingen suchen wir ab sofort einenMitarbeiter (m/w) im Qualitätsmanagement zur Ausbildung zum GxP-Auditor mit sehr guten Sprachkenntnissen in Deutsch, Italienisch, Französisch oder Spanisch (verhandlungssicher) (Vollzeit / befristet)Ihre Tätigkeiten: Unterstützung der Teamleitung in der Betreuung und Qualifizierung von Plasmalieferanten / Dienstleistern im Europäischen Raum Vorbereitung der Audits inklusive Reiseorganisation Durchführung von Qualifizierungsaudits bei Plasmalieferanten / Dienstleistern nach GxP im Europäischen Raum, Überprüfung der Compliance im Hinblick auf regulatorische und gesetzliche Vorgaben Evaluierung der Auditergebnisse, Durchführung von Risikoanalysen und Bewertung der Auswirkungen auf den Qualifizierungsstatus des Plasmalieferanten / Dienstleisters; Bewertung der korrektiven / präventiven MaßnahmenIhr Profil: Erfolgreich abgeschlossene Berufsausbildung oder abgeschlossenes Bachelorstudium im Gesundheitswesen oder im naturwissenschaftlichen Bereich; 2 - 3 Jahre Berufserfahrung wünschenswert; Fundierte Kenntnisse im Qualitätsmanagement und GxP-Bereich sowie Audit-/Inspektionserfahrung von Vorteil; Sicherer Umgang mit MS-Office-Standardsoftware; Bereitschaft zu intensiver Reisetätigkeit mit einem hohen Maß an Flexibilität; Analytisches und lösungsorientiertes Denkvermögen sowie strukturierte und selbständige Arbeitsweise; Team- und Konfliktfähigkeit sowie sehr gute Umgangsformen; Weitere Fremdsprachenkenntnisse wünschenswert; Ihre Benefits: Eine betriebliche Spezial-Ausbildung zum GxP-Auditor; Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung; Abwechslungsreiches sowie anspruchs- und verantwortungsvolles Aufgabengebiet; Angenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken Team; Eine attraktive Vergütung mit zusätzlicher Altersversorgung; Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, PSCQ_SQ, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Plasma CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Posted 30+ days ago

Sr Software QA Analyst-logo
Sr Software QA Analyst
Old Republic TitleMinnetonka, MN
Job Description: With over 116 years of history and a commitment to excellence, Old Republic Title is a leader of title and escrow services, dedicated to facilitating real estate transactions with the highest level of customer service. We are seeking candidates with experience in Software QA. This is a great opportunity to work for a Fortune 500 company and build a career in the title industry. About the Role: Old Republic Title is seeking a motivated and detail-oriented Sr. Quality Assurance Analyst to join our Information Services team. In this pivotal role, you'll be responsible for tracking and managing the overall testing effort of a project. You'll play a key part in leading the team in its processes and the execution of test plans. This is a hybrid role, so we are seeking candidates in Minnetonka (MN), Roseville (CA), or Tampa (FL). In this role, you will be required to: Determine appropriate manual and automated test methods based on use case scenarios and design appropriate test cases. Coordinate work effort of team members to ensure that testing is completed on time and meets requirements. Peer review automated test scripts created by other team members for quality standards and resiliency. Accountable for knowledge management and advanced documentation. Lead and mentor less experienced colleagues and enforce best standards, practices and documentation. Knowledge and Skills needed to be successful: Expertise in automated test methodology and can work with analysts and developers in creating, executing and revising test plans. Significant business process expertise and understanding of current production applications. Track and manage the overall testing effort of a project. Lead the team in its process and the execution of test plans. Peer review automated test scripts created by other team members for quality standards and resiliency. Determine appropriate manual and automated test methods based on use case scenarios and design appropriate test cases. Coordinate work effort of team members to ensure that testing is completed on time and meets requirements. Accountable for knowledge management and advanced documentation. Lead and mentor less experienced colleagues and enforce best standards, practices and documentation. Communication and Interpersonal skills to be effective: Excellent professional written, verbal, listening and communication skills. Must be a personable, positive, and professional representative of the company. Ability to foster, develop and maintain professional and collaborative working relationships. Must be able to get along with others, i.e., peers, employees, supervisors, outside customers, and vendors. Lead by positive example. Ability to collaborate and interact effectively and professionally with all levels of management, employees and customers by email, phone, video conferences and in person. Actively listens. Is mindful of how body language, gestures and nonverbal communications are perceived. Education requirement: Bachelor's or advanced degree in Computer Science, Information Systems, or related fields; or equivalent work experience. #LI-MB1 #QAAnalyst #SoftwareAnalyst The estimated pay range stated represents the typical pay range for this position or similarly employed employees or employees performing substantially similar work. Factors which may be used to determine the actual pay rate may include, but are not limited to, education, training or experience; seniority; merit and work performance; quantity or quality of production; regional differences in compensation; differences in local minimum wages, or ability and effort. Position's Pay Range: $100,000 - $130,000 Benefits may include: Comprehensive medical, prescriptions, dental and vision plans 401(k) plan with a discretionary company match Shareholder Purchase and Reinvestment Plan Basic life and accidental death and dismemberment insurance premium paid by the company Voluntary supplemental life insurance for employees, spouses and dependent children Fertility and Family Building Benefits Paid Disability benefits Paid time off programs 11 Company paid holidays per year Flexible spending account Health savings account (available to High Deductible Health Plan participants only) Employee Assistance Program Educational Assistance Program Voluntary benefits, such as Critical Illness, Hospital Indemnity, Pet Insurance and Accident Insurance Title insurance policies and certain escrow services for the employee's primary personal residence at no charge Transportation benefit plan for mass transit, parking and vanpool, in several markets Note: If you currently are employed by Old Republic Title (or one of its wholly owned affiliated companies) please get in touch with your human resources representative regarding the application process. For California applicants, please click the following link to view our CCPA Applicant Notice Old Republic Title is an Equal Opportunity Employer

Posted 1 week ago

QA Technician II (Day Shift - 12-Hour Rotating (2/2/3) Schedule)-logo
QA Technician II (Day Shift - 12-Hour Rotating (2/2/3) Schedule)
ResilienceWest Chester, OH
A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary: The QA Technician II is responsible for all QA activities that directly support execution of the process both within the Operations Areas and in assigned areas outside of Operations. These activities may include, but are not limited to, performance of AQL visual inspection, routine walk-throughs, on-the- floor support, and quality batch record on-the-floor review. Position Responsibilities: Performs AQL visual inspection Completes training and maintains required qualifications for visual inspection(s) Ensure regular presence in operational areas and support personnel on quality matters Maintains a high level of understanding of relevant production processes and quality systems Routine walk-throughs of applicable production areas inspection readiness of the facility Routinely communicate findings and ensure issues are corrected in a timely manner Ensures processes are executed according to batch records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified Provides constructive feedback to individuals executing batch records and communicates best practices to share with different areas of manufacturing Communicate clearly with cross-functional teams Supports QA processes including batch record review and quality issue escalation and resolution to maintain the flow of products and documents to meet site objectives Stays abreast of evolving regulatory compliance practices Minimum Qualifications: Excellent oral and written communication skills Strong ability and motivation to learn Preferred Qualifications: High School Diploma or equivalent, Associate's or Bachelor's degree Multi-site / multi-functional experience 3 + years of experience in Quality Assurance The items described here are representative of those that must be met successfully to perform the essential functions of this job. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $21.50 - $30.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Posted 30+ days ago

Senior Operations QA Manager - Clinical-logo
Senior Operations QA Manager - Clinical
Exelixis Inc.Alameda, CA
The Senior Operations QA Manager- Clinical is accountable for the QA oversight of day-to-day end-to-end (Drug Substance, Drug Product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, managing product complaints. This individual represents QA as the QA Partner (Primary Point of Contact), is the speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables. The Senior Operations QA Manager- Clinical manages Exelixis partnerships, collaborations, audits, forges strong relationships to maintain performance and continuous improvement, and demonstrates a high level of independent quality judgment and acumen. ESSENTIAL DUTIES AND RESPONSIBILITIES: Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP issues). Maintain and continuously improve QA programs, policies and procedures to ensure GMP compliance of commercial and clinical trial material. Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment. Oversee CMOs: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues. Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, etc.) Maintain and report CMO metrics and QA metrics. Identifies and rapidly mitigates risk. Contribute to APQR (annual product quality review) as applicable. Lead implementation of process and system improvements as applicable. Support implementation of quality systems, department and corporate procedures to ensure compliance with cGMPs. Evaluate and generate data to support KPIs (Key Performance Indicators) Understands regulatory requirements. Assists monitoring current and proposed quality and scientific issues and advises management of events critical for Exelixis. Delivers per supply plans and drives for results. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or, PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred Two years of experience managing Contract Manufacturing Organizations preferred Five years of relevant experience in the biotech/pharmaceutical industry. Experience in the development of metrics and continuous improvements is preferred Knowledge/Skills: Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines. Proven experience in a virtual manufacturing environment or relevant industry/profession. Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. Small molecule, oral solid form, biologics technical knowledge required. Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways. Implements technical solutions within quality requirements to complex problems. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Great attention to detail. Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics.•Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization. Excellent MS Office, Word, Excel and PowerPoint skills. WORKING CONDITIONS: This is an onsite position Travel as required #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $140,000 - $199,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Posted 1 day ago

Director, QA Great River, New York (On-Site)-logo
Director, QA Great River, New York (On-Site)
NetSmartGreat River, NY
Job Summary: The Netsmart Director, QA is responsible for the productivity and quality delivery of Netsmart programs assigned. Provides technical leadership for Netsmart Solutions across multiple products driving quality assurance processes via the SDLC and DevOps functions with direct hiring, development, and coaching of Associates. They are recognized as technology quality and solution visionary within the organization. This position works closely with all levels of Engineering, Cloud Hosting, Client Support, Consulting, and Client engagement. This role will be onsite in our Great River, NY office. Essential Duties and Responsibilities: Provide cross-functional technical leadership, coaching and guidance to leaders across the software development organization, including direct management and leadership for a quality assurance team. Maximize the capability and capacity of resources to deliver high quality solutions with a high functioning and accountable engineering test team. Strategize for and set business operational objectives, business requirements, roadmap assistance while overseeing the completion of department goals, strategies, and financial budgets. Effectively and routinely produce, review, manage to, and control operational and quality metrics and status. This is including but not limited to queue churn, trending, resource utilization, risk assessment and mitigation, project initiatives, and department-related data elements. Make timely and effective decisions to ensure the team is prepared to deliver solutions on a strategic roadmap not just for the short-term Identify, lead, and gain adoption of cross-functional change initiatives, challenging the status quo, and develop strategies to support change in engineering and test processes, framework, tooling, and strategy. Accountable for ensuring the capability and capacity of the team to advance and leverage the latest in programming languages, industry standards and software development methodologies. Become a trusted advisor for executive leaders across the company. Maintain knowledge of industry and departmental standards, policies and procedures, and movement to evaluate any strategic initiative impacts. Qualifications: Education Requires a Bachelor's degree in Computer Information Systems or Computer Science or equivalent combination of experience and education. Specialized Knowledge Must be able to read, understand, and develop code for web-based programming. This may include AWS, .Net, Java, ASP, HTML, SQL and .Net languages. Must understand general programming standards, operating systems, workflow cycles, development life cycle, and terminology. Requires a general understanding of business operations, business terminology, and business communications. Experience 10+ years programming leadership experience building web based enterprise software products leveraging C#, ASP.NET, & SQL, or specialized training combined with experience. Must demonstrate an ability to see the broader picture of impact of developed processes. Must understand development industry standards and practices. Must be able to demonstrate individual and team work effort in collaborative processes. Understanding of Object Oriented Programming Skills and Abilities Skills Preferred Experience performing and managing manual and automated test validation against secure, scalable and highly available web and mobile applications, large-scale distributed systems across technical stacks that use varying architectures such as: microservices, serverless architecture, or service-oriented. Experience working with a distributed workforce in varying time zones Experience with a variety of testing tools and frameworks: Selenium, Cucumber, Appium, JMeter, Postman, AWS, Lambda, AI Integration, BitBucket, TestNG, DevOps tools. Prior programming skills. Understanding of healthcare systems with focus in areas such as; medication management, claims processing, etc. Other Skills Requires the interpersonal skills to interact and collaborate with a wide variety of internal personnel. May interact with outside customer or mentor less experienced engineers. Requires the ability to work independently and self-initiate to test, troubleshoot, meet department deadlines, build proof-of-concepts, and learn industry and products as necessary. Requires the verbal skills to probe and ask questions to ensure understanding of requirements, participate in teams, and communicate technical issues to non-technical personnel. Requires the ability to read and interpret technical documents and write a variety of business and technical documents, including business plans and proposals. Requires strong presentation skills, to every level of internal and external organization. Travel Up to 10% domestic travel is expected for this position. This requirement may vary depending on location, and could be up to 25%. This position is not available for visa sponsorship. This position is eligible for relocation assistance. Ability to work onsite in our Great River, NY office. Salary range-140k-175K Eligible for health/medical benefits (Yes) Netsmart is proud to be an equal opportunity workplace and is an affirmative action employer, providing equal employment and advancement opportunities to all individuals. We celebrate diversity and are committed to creating an inclusive environment for all associates. All employment decisions at Netsmart, including but not limited to recruiting, hiring, promotion and transfer, are based on performance, qualifications, abilities, education and experience. Netsmart does not discriminate in employment opportunities or practices based on race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, physical or mental disability, past or present military service, or any other status protected by the laws or regulations in the locations where we operate. Netsmart desires to provide a healthy and safe workplace and, as a government contractor, Netsmart is committed to maintaining a drug-free workplace in accordance with applicable federal law. Pursuant to Netsmart policy, all post-offer candidates are required to successfully complete a pre-employment background check, including a drug screen, which is provided at Netsmart's sole expense. In the event a candidate tests positive for a controlled substance, Netsmart will rescind the offer of employment unless the individual can provide proof of valid prescription to Netsmart's third party screening provider. If you are located in a state which grants you the right to receive information on salary range, pay scale, description of benefits or other compensation for this position, please use this form to request details which you may be legally entitled. All applicants for employment must be legally authorized to work in the United States. Netsmart does not provide work visa sponsorship for this position. Netsmart's Job Applicant Privacy Notice may be found here.

Posted 1 week ago

QA Engineer-logo
QA Engineer
Doran Jones Inc.Jersey City, NJ
Doran Jones is seeking a Test Automation Engineer to join a highly skilled Agile team. You will be working to support a nationwide financial services firm, relying on a robust QA and test engineering stack. Their tools include Selenium and Cypress for UI testing, JUnit and TestNG for unit testing, Postman for API validation, and Jenkins for CI/CD. They prioritize test automation, performance, and reliability across environments. Be part of a transformative initiative, modernizing legacy systems into scalable, secure, and efficient cloud-based solutions. Work with a cutting-edge tech stack while contributing to impactful projects in the financial services and auto finance sectors. Responsibilities Collaborate with developers, business analysts, and stakeholders to understand product requirements. Ensure comprehensive manual testing coverage, including agreement on acceptance criteria and scripting. Develop and document comprehensive test plans based on project requirements and timelines. Design, create, and maintain detailed, comprehensive, well-structured test cases. Define QA standards in collaboration with development teams and third parties. Establish and maintain Test Data Management processes, standards, and automation. Execute test cases (manual or automated) and analyze results. Perform regression testing to ensure new changes do not adversely affect existing functionalities. Lead the development of Automated Testing Scripts, regression testing, and smoke testing strategies. Develop and maintain automated test scripts using various testing tools and frameworks. Integrate automated tests into the CI/CD pipeline. Required Experience 5+ years of experience in full-stack testing, including both manual and automation testing. Strong general-purpose Java coding experience – intermediate to senior (e.g., designing concepts such as OOP; libraries like pandas, techniques like profiling, regex, collections, exception handling patterns, introspection, advanced data structures, others). Experience in Cloud technologies, including AWS and/or Azure. Experience with IaaC, including Terraform. Strong knowledge of Selenium. Strong knowledge of SQL, including transaction processing concepts, and large-scale dataset manipulation for test initialization. Technologies include browser event model and DOM, HTML5/CSS3, Excel, JMeter/Load runner/Soap UI, webservices, XML/HTML parsing, distributed version control systems, JIRA, shell, and scripting. Good understanding of protocols (HTTP/Rest) and message formats (JSON, XML) Understanding of test cases and test input generators, including combinatorial tools Excellent communication skills (verbal and written), presentation, client management skills, and forensic attention to detail. Good understanding of CI/CD concepts, tools, and best practices. Actual compensation may vary based on factors such as role, work experience, education and training, skill level, market conditions, and the candidate's geographic location. We offer a competitive compensation package, including a base salary, comprehensive health care coverage, disability benefits, a 401(k) match, life insurance, paid personal days, paid holidays, and paid time off, among other benefits. For those in eligible roles, a discretionary bonus may be awarded based on company performance and in recognition of individual achievements and contributions. Additional details about total compensation and benefits details during the hiring process. Doran Jones Inc. (DJI) is the leading financial services Data Engineering and Application Development firm, specializing in Capital Markets, Risk, and Regulatory Compliance. We are US-based, helping our clients fill gaps in capacity and expertise, reduce risk, and accelerate change. Our leaders average over 25 years of experience in Financial Services and Technology. DJI is repeatedly engaged by the largest and most complex clients for our Agile transformation expertise and practical understanding of the critical relationship between data, architecture, and application development. DJI has a mission to place more people from non-traditional backgrounds into sustainable technology careers. Through partnerships with non-profit technology programs in underserved communities and Veteran organizations, candidates transition from tech training programs into real IT careers at DJI. Our unique recruitment policy allows us to create exceptional teams, bringing a broad spectrum of experience to our company and creating anything but a traditional consulting firm. DJI is a wholly-owned subsidiary of McLaren Strategic Ventures, a private equity firm, that invests in start-ups and scale-ups. They provide a full range of highly trusted domain consulting, advisory services, and innovative technologies globally. Doran Jones is able to offer a broad range of technology, deeper AI and machine learning tools, data intelligence, alternative resourcing capabilities, and capital access to invest and digitize at scale. Our clients benefit from this unique portfolio allowing them to accelerate the pace of their own digital transformations through innovative products and services designed around industry-wide issues. Visit Doran Jones to learn more!

Posted 30+ days ago

QA Tech (2Nd Shift)-logo
QA Tech (2Nd Shift)
Reser's Fine Foods Stay Connected Email AddressSalem, OR
General Summary: Monitors key process control points during production operations. Documents and reports any food safety or quality issues so that corrective actions can be taken. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser's offers choices whenever possible, because we recognize the diverse and ever changing needs of our employees. Full-time employee benefits include medical, dental, vision, AD&D, life, 401(k) with discretionary match, wellness programs, paid time off, company paid holidays and a variety of voluntary benefit options. We strive to be your Employer of Choice. As one of our five cornerstones, this means that we go all-out to create an environment that shows we are committed to investing in employee growth and creating a culture of belonging where employees want to build a lasting career. Principal Duties and Responsibilities Documents and reports any food safety or quality issues and participates in determination of corrective actions to be taken. May assist with pre-operational inspection of production plant and equipment and completion or related documentation. Performs process verification checks at critical food safety and quality points according to the facility's Food Safety Plan and Quality Plan. Participates in determination of corrective actions when verification checks do not meet the limits defined in the facility's Food Safety Plan and Quality Plan. Verifies the facility's environment including items such as temperature throughout the production facility, sanitizer concentrations and other food safety related conditions. Completes Hold Tags and Cooling Tags, if appropriate, to isolate non-conforming ingredients or products. Conducts and documents the daily product review; participates in evaluation of key sensory attributes of finished products. Responsible for maintaining records, completing documentation, following proper documentation protocols as assigned Adherence and monitor of programs including HACCP Program, good manufacturing practices, foreign material control, plant sanitation, product quality assurance and other programs as assigned As part of monitoring CCPs (Critical Control Points), must be trained in HACCP (Hazard Analysis Critical Control Point) and adhere to approved HACCP plan(s) Job Specifications Associate degree in a science related field or 1+ years in a Quality Assurance position or equivalent experience. Basic knowledge of GMP's, Food Safety, and Safety requirements Ability to read, write and speak in English at a level of proficiency to clearly understand items such as food safety documentation, ingredient labels, etc. is required. Basic computer skills; e-mail, Word, Excel. Regular attendance and punctuality are required. Working Conditions Food processing, warehouse and food laboratory environment. The environment may be wet or dry and temperatures may range from 25oF to 110oF. Regularly required to stand and walk, ability to climb ladders, bend, reach and occasionally lift up to 40 lbs. Production demands may require overtime and/or evening or weekend scheduling Recipe for Success Reser's is the leading provider of fresh refrigerated deli salads, side dishes, and prepared foods for the supermarket, club store, and food service industries. Family owned and operated, Reser's has been a proud sponsor of good times at racetracks, picnics, BBQs, music festivals, and affordable family meals since 1950. Reser's family of brands include Reser's American Classics, Main St Bistro, Stonemill Kitchens, and more. With more than 4,500 employees, Reser's operates 14 facilities in the US, Mexico, and Canada and actively supports the communities it serves.

Posted 30+ days ago

Lab Technician – QA & QC (Environmental Testing)-logo
Lab Technician – QA & QC (Environmental Testing)
StimLabsRoswell, GA
Provides key Quality and Laboratory support to the StimLabs organization Operates under the supervision of Quality Management. Performs testing to ensure correct composition and to identify any quality issues. Participate in sample preparation and critical thinking in collaboration with Operations. Collects and tests environmental monitoring samples from the cleanrooms and associated controlled areas Acts as primary lab technician performing daily testing, such as mechanical testing (e.g. peel strength) and analytical testing (e.g. residual moisture, content analysis, cell culture) and microbiology testing. Suggests and implements improvements of sample testing and test methods. Acts as a laboratory representative within the organization, raising awareness for laboratory standards and education. Contributes to the development of lab-related infrastructure for new products. Assists or lead on a variety of projects as designated by Quality Management. Conducts activities and documentation related to Quality Control. Participates in daily operations of the Quality department including but not limited to: Setting up Quality Control laboratory equipment and performing Quality testing. Assists or manages calibration of lab equipment in preparation for specific tasks. Prepare samples and reagents for testing and retention. Follow all company policies and procedures to ensure product integrity and quality control. Analyze retrieved data and prepare laboratory reports to management. Recognize and report any product safety issues. Provide critical thinking for problem solving. Develops, validates and implements mechanical and analytical test methods. Assists with incoming inspection and release of all raw materials (including donor tissue when applicable), components, sterilized bulk product, and supplies to ensure compliance with applicable regulations and requirements. Assists and collaborates on development of Standard Operating Procedures, Work Instructions, Forms, sampling plans, and specifications. Assists with in-process and finished product Quality Control inspections of materials and products to ensure compliance with product specifications and regulatory requirements (residual moisture analysis, package integrity, sterilization verification, dimensional specifications, visual inspections, etc.). Reviews biological indicators from sterilization cycles to ensure sterilization cycle parameters and specifications were met. Performs with environmental monitoring sampling (viable air, viable surface and non-viable particulates) and testing as needed. Collaborates with Quality and/or Operations to complete investigations related to laboratory failures or out-of-specification events and documentation. Assists with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, and Complaints, as directed by Quality Management. Maintains laboratory testing schedule to ensure test results are available in a timely manner. General administrative tasks such as scheduling, filing, organizing etc. Assists with general lab cleaning and upkeep on a regular basis. Maintains MSDS records for laboratory reagents and chemicals. Assists in keeping up with lab component maintenance schedules. Assists with taking lab inventory and ordering lab supplies as needed. Support inspections and audits from regulatory agencies, as needed. Assists in training employees on new tasks/functions when designated by Quality Management. Performs additional activities as assigned by Quality Management. EDUCATION/CERTIFICATION Bachelor's degree in a technical/relevant field, with at least three to five (3-5) years of Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience. REQUIRED KNOWLEDGE Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, 21 CFR 820, 21CFR 211, and other applicable state and federal regulations. Document Control Management (document changes as well as maintenance of Quality records) in a cGMP regulated environment required. Capable of prioritizing tasks to meet goals and ensure product quality. Experience in tissue banking preferred but not required. StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the untapped synergy at the intersection of these independent domains. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.

Posted 30+ days ago

Manager/ Senior Manager - Gxp Quality Systems (QA Vendor Management)-logo
Manager/ Senior Manager - Gxp Quality Systems (QA Vendor Management)
Ionis Pharmaceuticals Inc.Carlsbad, CA
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our work environment a place where solid and lasting relationships are built and where our culture and employees can thrive. We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! MANAGER / SENIOR MANAGER - GXP QUALITY SYSTEMS (QA VENDOR MANAGEMENT) SUMMARY: We are seeking an experienced Manager / Sr. Manager with strong knowledge and expertise in Vendor Management and Internal Audits Programs. The ideal candidate will be highly motivated, detail-oriented, inquisitive, and can drive activities, assignments, and tasks to completion in accordance with established expectations and timelines. This role is for an individual contributor reporting to the Assistant Director, GxP Quality Systems (QA Vendor Management). Primary responsibilities will focus on operational execution of vendor management activities (e.g., vendor on- and off-boarding, service provider / vendor qualification, auditing, performance monitoring, and measurement / metrics), working with multi-disciplinary and cross-functional teams regarding change and quality event management (including CAPA), internal audits, material qualification, quality agreement preparation and management, and risk management. Preference will be given to candidates possessing strong compliance and Quality System experience (including QA applications), and knowledge of domestic and international cGMP regulatory requirements (e.g., FDA, Eudralex, Health Canada, ICH, MHRA, MHLW, etc.). Experience with small molecules, biologics, medical devices and / or combination products is desired. Candidates must also have excellent verbal and written communication skills, and strong analytical and problem-solving abilities to address issues of moderate complexity. Furthermore, the candidate must be able to work in a dynamic and fast-paced environment, be a team player, maintain professionalism, and be able to work with multi-disciplinary, cross-functional teams on high impact projects delivering quality results in accordance with agreed upon timelines. This onsite / hybrid role will be based in our headquarters office located in Carlsbad, CA. RESPONSIBILITIES: Lead and execute Vendor Management Program processes in accordance with the established risk-based model ensuring there is no interruption to business activities. Manage and track new Vendor Requests including working with our customers / stakeholders regarding risk assessment and scoring and delivering results in accordance with agreed upon business timelines. Strong knowledge and experience with planning, preparing, conducting, and documenting cGMP Vendor and Internal Audits (including onsite, remote and questionnaire audits) in accordance with applicable domestic or international regulatory requirements and industry best practices. Manage Vendor Change Notifications collaborating with customers / stakeholder regarding impact and quality assessments and ensuring adherence to vendor change timelines and internal / regulatory requirements, as applicable. Perform quality event investigations including CAPA development and Effectiveness Checks, as required. Lead and manage Quality Agreement Program. Initiate, negotiate, establish, and periodically update new and existing agreements with our cGMP vendors, as applicable. Adheres to standard process lead times and ensures alignment with key performance indicators and relevant measures / metrics. Strong intra- / inter-company communication skills, ability to think critically and influence others, and problem solve, and possesses solid technical writing skills. Ability to work independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. Collaborate or lead projects that drive continuous quality improvements, implement best practices and /or enhance compliance to domestic and international regulatory requirements. REQUIREMENTS: B.S. in Chemistry, Chemical Engineering, or related discipline; advanced degree preferred. Manager: Requires a minimum of 3 years in the Life Sciences or Pharmaceutical industry with relevant Quality Assurance experience and 2+ years of GMP Vendor Management experience strongly preferred; or an advanced degree without experience; or equivalent work experience Senior Manager: Requires a minimum of 5 years in the Life Sciences or Pharmaceutical industry with relevant Quality Assurance experience and 4+ years of GMP Vendor Management experience strongly preferred; or 3 years and a master's degree; or equivalent work experience Knowledge of domestic and international cGMPs Experience regarding quality event investigations, problem solving, and process improvement (with emphasis on cGMP compliance) Focused on what matters and committed to delivering high quality results and resolving challenges and issues in a timely manner Travel up to 15% may be required Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003729 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded The pay scale for this position is $73,618 to $120,971 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Posted 1 week ago

QA Document Specialist-logo
QA Document Specialist
Oil States International, Inc.Arlington, TX
For over 80 years, Oil States has been a highly respected technology and solutions pioneer manufacturing diverse products for offshore platforms, subsea pipelines, defense, and general industrial applications worldwide. Oil States recognizes that our diverse workforce is our greatest asset. We offer a competitive compensation package, including paid time off as well as health insurance eligibility on the first day of employment. Paid time off includes vacation, holiday and sick time. Benefits include medical, dental, vision, 401k, life insurance, long and short-term disability, and flexible spending accounts. When we contribute to the company's success, we all win. In our organization, the QA Document Specialist has a critical and challenging role in helping achieve innovation and meeting our commitments POSITION SUMMARY: Support quality control and document control activities and maintain quality control records. ESSENTIAL DUTIES AND RESPONSIBILITIES: Organize, index, collate and file all quality control records which include completed inspection reports, certifications, nonconformance reports, test results, databooks and Manufacturing and Inspection Procedures (MIP's). Manage scanning of quality records at all OSI Arlington locations. Partner with Document Control in the filing and organizing of quality records in Master Control. Design and issue certificates of conformance with shipment of goods. Design, organize, compile and maintain project databooks and related quality documentation. Organize and compile quality records and data books for external OSI locations. Perform general office and receptionist work for the department. Issue inspection stamps - maintain and periodically audit stamp log. Maintain serialization logs for multiple product lines to ensure traceability. Enter all purchase requisitions for the department. Distribute and maintain supplier surveys for ASL maintenance. Design and create forms, labels and barcodes that improve/enhance work flow operations. Perform final testing acceptance, certification and ship out of resilient mount products. Perform other duties as assigned by supervisor. QUALIFICATION REQUIREMENTS: High school diploma or equivalent with at least 1 or more years of quality or related manufacturing experience. Proficient computer skills (Word, Acrobat, Excel and Outlook). Experience using Glovia a plus. Experience using Master Control a plus. Proficient with basic math (addition, subtraction, multiplication and division). Effective communication/interpersonal skills, verbal and written. PHYSICAL REQUIREMENTS: Daily use of a computer, office phone and office equipment (copier, scanner, fax, etc.) Light to moderate physical effort may be required. Prolonged sitting may be required. CITIZENSHIP REQUIREMENTS - By contractual requirements this position requires that all persons establish proof of US Citizenship. Dual Citizenship (US citizenship and citizenship of some other country) cannot be accepted. You will be required to provide original or certified copies of documents establishing your citizenship prior to consideration for this position. Be part of what's next at Oil States! Over 80 years in business An Equal Opportunity Employer An E-Verify Employer Un empleador de E-Verify

Posted 1 week ago

QA+QC Manager (Beauty Products)-logo
QA+QC Manager (Beauty Products)
Thrive CausemeticsLos Angeles, CA
Location: In-Office 4 days/week in Playa Vista, CA HQ Who We Are: Thrive Causemetics is Bigger Than Beauty™: We are an independent, female-owned beauty brand that creates high-performance vegan cosmetics and supports a community of giving. All of Thrive Causemetics' products are free of parabens and sulfates, in addition to being 100 percent cruelty-free. Through its Bigger Than Beauty™ program, every product purchased results in a donation to help communities thrive. Thrive Causemetics is dedicated to fostering a collaborative and cross-functional workplace where everyone’s voice matters. We are committed to being pioneers in creating a culture of wellness. Together, we prioritize a strong work ethic while maintaining a positive, exciting environment where people are passionate about what they do. Who We Are Looking For: We are seeking an experienced QA/QC Manager to lead quality assurance and quality control efforts across our color cosmetics and skincare product lines. This critical role will oversee all aspects of product quality, ensuring that our formulations, packaging, and finished goods meet the highest standards of safety, performance, and regulatory compliance. As the QA/QC Manager, you will work closely with internal teams, contract manufacturers, and external testing partners and warehouses to uphold our brand’s reputation for exceptional quality. This role will require occasional travel to physically audit inventory and visit CMs to inspect product quality. What You Will Be Doing: Develop, implement, and maintain a robust Quality Management System (QMS) tailored to the needs of the business. Establish and document standard operating procedures (SOPs) for product development, manufacturing, and testing processes. Conduct audits of contract manufacturers and suppliers to ensure adherence to quality standards, GMP (Good Manufacturing Practices), and regulatory compliance. Collaborate with R&D and Product Development teams to integrate quality protocols early in the product lifecycle. Oversee the testing of bulk formulations, and finished products to ensure consistency, safety, and efficacy. Manage third-party labs and testing facilities for microbiological, stability, and compatibility testing. Create and implement incoming inspection protocols for packaging, raw materials, and finished goods. Investigate and resolve quality issues, including product non-conformance, consumer complaints, and manufacturing deviations. Stay current with global cosmetic regulations (FDA, EU, etc.) and ensure all products meet applicable standards for safety and labeling. Support documentation and regulatory submissions, including Safety Data Sheets (SDS) and Product Information Files (PIF). Train and mentor cross-functional teams on quality standards and best practices. Lead root cause analyses and corrective/preventive action (CAPA) initiatives. Ability to travel domestically and internationally when needed to CMs to physically audit line trials and facilities. Ability to travel domestically and internationally when needed warehouses to conduct an AQL (acceptance quality limits) on incoming product shipments. What Will Make You Stand Out: 5+ years of QA/QC experience in the beauty or personal care industry, specifically with color cosmetics and skincare or similar consumer products. Strong understanding and ability to analyze cosmetic products, manufacturing processes, and documentation. Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Proficiency with QMS software and familiarity with cosmetic testing methods (e.g., microbiological, stability, compatibility). Bachelor’s degree in Chemistry, Chemical Engineering, Cosmetic Science, or a related field. Thrive Causemetics is an Equal Opportunity Employer. Applicants must be authorized to work for any employer in the U.S. without current or future sponsorship for an immigration-related work benefit. Thrive Causemetics does not hire H-1B, F-1 CPT, OPT, or STEM OPT candidates for this role. The base pay range for this role is $85,000 - $105,000 with the following factors determining the base pay at offer: skills, qualifications, experience. This range provides the opportunity to progress as you grow and develop within a role. Additionally, this role is also eligible for an annual discretionary bonus based on company and individual performance. Thrive Causemetics provides a competitive benefits package, including but not limited to: comprehensive medical, dental and vision plans, a 401(k) plan with employer matching, various paid time off programs, employee discount/perks, life insurance, disability insurance, and employee assistance programs.

Posted 30+ days ago

Senior Content Management Analyst- Tax QA-logo
Senior Content Management Analyst- Tax QA
Wolters KluwerWichita, KS
Sr. Content Management Analyst- TAX QA Analyst POSITION The Senior Tax Content QA Analyst (the "Senior Tax Analyst") is responsible for ensuring the completeness, correctness, and overall quality of CCH Axcess Tax and CCH ProSystem fx Tax ("CCH Software"). The Senior Tax Analyst must be versed in tax law, capable of providing clarification and interpretation to the software development team when needed, as well as conducting tax research using various electronic tools. Ultimately, the Senior Tax Analyst is responsible for the overall quality of the tax software and ensuring the best user experience. NOTE: Software development experience (coding/programming) is not required. All necessary process training will be provided by the Company. ESSENTIAL DUTIES AND RESPONSIBILITIES Conduct product testing to ensure the software functions as designed and content is accurate and in compliance with various taxing authorities' rules and regulations Collaborate with software developers to ensure optimal design and implementation, being mindful of the user experience Conduct regression testing to ensure new product implementation or other changes do not create unexpected failure elsewhere Create and deliver tax training Create and publish internal and customer-facing tax resources Resolve software content and tax questions posed by the Customer Support team or directly from customer MINIMUM QUALIFICATIONS Minimum 5 years of tax preparation experience, ideally with multiple tax return types (e.g., individual, partnership, corporate, etc.) Minimum 3 years' experience using CCH Axcess Tax and/or CCH ProSystem fx Tax software Bachelor's degree in Accounting or Finance, or related field CPA preferred, but not required Proficient using MS Office suite, including MS Teams ADDITIONAL KNOWLEDGE, SKILLS, & ABILITIES Strong analytical and critical thinking skills Self-motivated, organized, and effective at prioritizing and multitasking to ensure deadlines and objectives are met Highly developed problem-solving skills Strong attention to detail Ability to thrive in a deadline-driven team environment and work under pressure Strong interpersonal communication skills, with a desire to learn Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process.

Posted 30+ days ago

Group Leader - QA Technician-logo
Group Leader - QA Technician
Silgan Containers CorporationSlatersville, RI
About Silgan Dispensing: Silgan Dispensing is a global leader in the design and manufacture of highly engineered dispensing solutions for a variety of industries including beauty, personal care, home, and healthcare. Our commitment to quality, innovation, and operational excellence ensures that the world's most trusted brands rely on us to deliver precision and performance every time. Position Overview: As a Group Leader - QA Technician, you will play a critical leadership role in driving product quality and process excellence within our manufacturing operations. You will be responsible for maintaining process control systems, maintain and perform work to quality standards, offering recommendations for improvement, and leading a team of QA Technicians and Inspectors across multiple shifts. This is a hands-on role where you will serve as a key link between quality assurance and production, empowering the team to identify, analyze, and resolve quality issues quickly and effectively. Key Responsibilities: Leadership & Team Development Lead and mentor QA Technicians, Inspectors, and QC Sorters across all shifts. Conduct on-the-job training and coach team members on quality procedures and best practices. Support annual performance review processes and ongoing development of the QA team. Quality Systems & Process Control Oversee daily quality operations to ensure compliance with customer specifications, internal standards, and ISO requirements. Manage and maintain the calibration system and all associated documentation. Conduct root cause analysis and failure investigations; generate detailed reports and corrective action plans. Facilitate MRB (Material Review Board) activities and maintain accurate records of non-conforming materials and resolutions. Drive continuous improvement through data analysis, trend reporting, and problem-solving initiatives. Testing, Inspection & Reporting Perform first piece inspections, in-process audits, and final product evaluations using various inspection tools and techniques. Generate clear and accurate test reports, summarizing findings and identifying trends. Measure components such as caps and closures, reporting dimensional accuracy and process stability. Recommend updates and improvements to inspection procedures based on findings. Compliance & Documentation Ensure accurate and timely documentation of quality records, product retains, and audit results. Maintain adherence to quality plans, safety procedures, and housekeeping standards. Requirements: High school diploma or GED required; post-secondary technical training a plus. Quality Technician Certification strongly preferred. Minimum 5 years of experience in quality assurance, inspection, or manufacturing operations. Proven experience with test equipment, process audits, and ISO 9001 standards. Strong mathematical skills including ratios, fractions, and data interpretation. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Strong attention to detail, analytical thinking, and organizational skills. Ability to work independently and make data-driven decisions. Capable of lifting up to 50 lbs occasionally and meeting vision-related job requirements (color, depth, distance, focus). Why Join Silgan Dispensing? Competitive salary and benefits A company culture that values innovation, teamwork, and leadership A stable, growth-oriented environment with opportunities to make a direct impact LIMITATIONS AND DISCLAIMER The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an "at-will" basis. Silgan is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, or the presence of a disability, which would not prevent the performance of essential job duties with, or without reasonable accommodation of any other protective status. Silgan is a drug-free workplace.

Posted 30+ days ago

Associate Director, Research & Clinical Development QA-logo
Associate Director, Research & Clinical Development QA
Blueprint Medicines CorporationCambridge, MA
How will your role help us transform hope into reality? Oversee the quality assurance of all Good Pharmacovigilance Practice (GVP) activities to ensure that third party vendors remain compliant with and prepared for potential Sponsor and Regulatory Inspections, and ensure that the appropriate processes, systems, and activities are in place and performed to protect the rights, safety and welfare of patients participating in clinical trials. What will you do? Provide QA support a to the Drug Safety and Pharmacovigilance team, the QPPV, and Blueprint QA Oversee the QA activities of DSPV activities at Blueprint Medicines to ensure that all third party vendors remain compliant with and prepared for potential Sponsor and Regulatory Inspections; Utilize expertise in Regulatory Affairs and Pharmaceutical Science to ensure that the appropriate processes, systems, and activities are in place and performed both internally and externally to protect the rights, safety and welfare of clinical patients; Oversee and assess GVP processes to ensure continued safety and compliance; Develop the R&CD QA function to ensure high quality execution of clinical trials from first in human through commercial marketing authorization, and the pharmacovigilance activities following commercialization; Manage all cross functional relationships with internal and external stakeholders; Serve as the expert and point of contact for all Quality Assurance, DVSP, and QPPV teams; Support DSPV training programs to align with company quality objectives, strategies, and processes; Review and develop SOPs, other controlled documents, and training courseware for DSPV teams; Oversee development of risk-based DSPV-related auditing schedules and internal and external inspection readiness activities; Direct the DSPV vendor audit, internal audit, and inspection procedures and address audit observations; Present the DSPV QA activities during regulatory inspections and support QA organizations during regulatory inspections; Review and provide QA support for maintenance of Pharmacovigilance System Master File (PSMF) and Safety Data Exchange Agreement (SDEA); Identify and escalate critical DSPV findings to Senior Management; Track Key Process Indicators (KPIs) for reporting of Quality Metrics; Develop, manage, implement, and improve internal Quality Management System for DSPV; Approve deviations and Corrective and Preventive Actions (CAPAs), perform investigations and root cause analysis; Review and approve Safety SOPs, WI, guidelines, training compliance and regulatory compliance; Oversee generation and review of documents used in DSPV activities; Utilize expertise to interpret regulations as they apply to DSPV and provide guidance to the DSVP and QA teams on specific regulatory frameworks, including EU GVP, and FDA. May telecommute from any location in the US. What minimum qualifications do we require? Bachelor's degree in Regulatory Affairs, Pharmaceutical Science or a related field (or foreign equivalent degree), plus 5 years of experience in working in a quality role in GVP Quality Assurance. Experience, which may be gained concurrently, must include: 5 years of experience working in Clinical Quality Assurance for sponsor companies, CROs, and/or Drug safety auditing. 2 years of experience auditing/inspections under EU and/or FDA regulations. 4 years of experience in providing logistic and execution support for Regulatory Authority GVP Inspections. 2 years of experience in auditing Pharmacovigilance (GVP), Clinical Research (GCP), Regulatory affairs, quality assurance and GxP auditing. Excellent knowledge of Global Drug safety and Pharmacovigilance regulations and industry standards. Excellent communication, writing and presentation skills. What additional qualifications will make you a stronger candidate? Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism Why Blueprint? At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators - the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success. This is the place where the extraordinary becomes reality, and you could be part of it. Patients are waiting. Are you ready to make the leap? Equal Employment Opportunity At Blueprint Medicines, we foster an environment of fair treatment and full participation for all of our employees as we navigate complex challenges in pursuing our mission to improve the lives of patients. We celebrate our unique differences and varied career and life experiences so that we can sustain our diverse culture and ensure everyone feels accepted. We are committed to non-discrimination, equal employment opportunity, as well as an inclusive recruitment process. We consider all qualified applicants based on merit and without regard to race, color, sex, gender identity, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable federal or state law. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. We are also an E-Verify Employer. For more information, please see our EEO Policy Statement, the E-Verify Participation Poster, the Right to Work Poster, and/or the EEO Know Your Rights Poster. Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors. This position is part of Blueprint Medicines' employee referral program and is eligible for an employee referral incentive bonus. #LI-DNI

Posted 30+ days ago

Software QA Engineer I-logo
Software QA Engineer I
Life FitnessFranklin Park, IL
Join us as we empower the world to work out, creating healthier lives together. About the Opportunity: We are seeking a detail-oriented and passionate QA Engineer to join our Software Quality Assurance team. In this role, you will help ensure our fitness products meet the highest standards of quality. You will conduct hands-on testing on a variety of equipment to verify functionality, safety, and user experience. The ideal candidate has a technical background, strong analytical skills, and a passion for finding and solving problems. This position requires the ability to work independently, manage testing priorities, and take ownership of quality assurance processes while still collaborating effectively with the broader team. this is a hybrid position based out of Franklin Park, IL - M/F remote and T-Th are in-office collaboration days #LI-Hybrid Primary Duties and Responsibilities: Execute test cases and perform exploratory testing to identify bugs and usability issues with our fitness equipment Conduct end-to-end testing of software features, including integration with mobile and web applications Verify proper hardware integration between our software application and fitness equipment Document test results, log defects, and verify bug fixes Collaborate with developers, product managers, and other QA team members to understand requirements and resolve issues Participate in troubleshooting technical issues and providing clear, detailed reproduction steps Assist in creating and maintaining test documentation, including test plans and test cases using JIRA stories, functional specifications and design documents Participate in regular QA meetings and sprint planning sessions Knowledge, Skill, and Ability Requirements: Bachelor's degree in Computer Science, Engineering, or related field (or equivalent practical experience) 0-2 years of experience in software testing Basic understanding of software testing methodologies and best practices Familiarity with bug tracking and test management tools (e.g., Jira, TestRail) Problem solving skills necessary to analyze issues and determine workable solutions Strong attention to detail and analytical thinking skills Excellent communication skills and ability to clearly document technical issues Preferred Qualifications Knowledge of API testing concepts Experience in an Agile development environment Basic knowledge of at least one programming or scripting language is a plus Interest in fitness and fitness technology At Life Fitness / Hammer Strength, we believe in taking care of our team with a comprehensive total rewards package that includes competitive pay and a range of valuable benefits. The salary range for this position, intended for U.S. applicants, is $68,600 - $97,600 annually.The actual salary will vary based on applicant's education, experience, skills, and abilities. The salary range reflected is based on a primary work location of Franklin Park, IL and the actual salary may vary for applicants in a different geographic location. Life Fitness / Hammer Strength offers a comprehensive package of benefits for full-time team members, including, but not limited to: a 401(k) savings plan with 4% employer match; medical, dental and vision insurance, parental, medical and military leaves of absence, paid time off, including 12 paid holidays throughout the calendar year, paid vacation days beginning at 13 days annually, paid sick leave as provided under state and local paid sick leave laws, company paid short-term disability and optional long-term disability, health savings account, health care and dependent care reimbursement accounts, employee and dependent life insurance and supplemental life and AD&D insurance, hospital indemnity; identity protection, legal services, adoption assistance, tuition assistance, commuter benefits, employee discounts, and an employee assistance program that includes free counseling sessions. Eligibility for benefits is governed by the applicable plan documents and policies. Want to take the next step in your career? Life Fitness/Hammer Strength takes pride in our talented employees and believes in providing opportunities for further growth and advancement. We encourage you to test your strengths, push your limits, and unleash your potential. If you feel the position is right for you, we invite you to apply. We'll work with you closely to support you throughout the hiring process. If your CV/ resume shows that your skills and experience have synergy with the job description, then we'll hop on a call to get to know you and your experience and discuss the position in more detail. If it's not the right opportunity this time, we'll always let you know. Life Fitness / Hammer Strength is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply. Life Fitness / Hammer Strength complies with all applicable federal, state, and local laws regarding employment, recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by applicable federal, state, or local laws. There continues to be a significant increase in phishing attempts across all industries where fraudsters are impersonating real employees and sending fictitious job offers to applicants in a scheme to obtain sensitive information. Please note that Life Fitness/Hammer Strength will never ask for your financial information at any part of the interview process, including the post-offer stage, and will only correspond through "@lifefitness.com" or "@indoorcycling.com" domain email addresses or "lifefitness@myworkday.com" for U.S. opportunities. Life Fitness/Hammer Strength does not accept applications, inquiries or solicitations from unapproved staffing agencies or vendors.

Posted 1 week ago

QA Tech- Night Shift $24.50-logo
QA Tech- Night Shift $24.50
The Coca-Cola Co.Auburndale, FL
Location(s): United States of America City/Cities: Auburndale Travel Required: 00% - 25% Relocation Provided: No Job Posting End Date: June 12, 2025 Shift: Third Shift (United States of America) Job Description Summary: As the world's largest beverage company, we produce the highest quality products, which our consumer has come to expect from us. We are currently seeking Technicians to join our manufacturing team in a Quality Assurance role. You'll be responsible for quality testing of ingredients and finished products to ensure product and package integrity in accordance with standard operating procedures. We're seeking team-oriented individuals who have a keen eye for the details and have a passion for ensuring the quality of their work. What You'll Do for Us Perform collection, documentation, and destruction of samples, along with physical, chemical, and microbiological testing of finished products and raw materials. Communicate effectively and thoroughly to management and peers on test results or inspection findings outside of specifications. Conduct environmental sampling and analysis to monitor facility sanitation. Conduct all laboratory testing with accuracy and integrity and ensures that it is accomplished in compliance with all federal, state, and company policies and procedures. Keep accurate, complete, and legible records. Properly amend, identify, and file records, along with conducting clerical duties including copying, filing, faxing, data entry, and document reproduction. Safely handle/use chemicals, biological agents, and waste. Potentially including hazardous materials. Read, understand, and maintain material safety data sheets. Perform routine maintenance tasks on process equipment and monthly audits on various areas under laboratory control. Complete work orders to ensure proper maintenance, verification, calibrations are completed in a timely manner in accord with company, federal and state requirements Utilize software including word processing, spreadsheets, and inventory control systems. Set-up and calibrate test equipment. Monitor all quality checks made by production. Keep accurate Q.A. reports daily. Operate and perform quality tests on the treated water system. Qualification & Requirements High school diploma, GED equivalent, Associate degree, or technical college degree. 1+ years' experience in quality testing or manufacturing environment preferred. Must be able to maintain a strong level of confidentiality - all formulas are confidential. Solid math skills are required along with basic reading and writing skills. Must successfully pass Aon (behavioral/personality test) assessment test. Ability to demonstrate capability of learning or using basic lab's equipment such as: Refractometer, pH meter, Auto titrator, Density Meter, Turbidity Meter. Must have strong problem-solving skills and the ability to work efficiently under stressful situations. Comply with all Safety, Environmental, Security, and Good Manufacturing Practice policies. Microsoft office experience Ability to read equipment operations manuals. Ability to visually identify and recognize material, part, and product defects. Ability to participate in job development training Ability to work in a team environment. The Coca-Cola Company will not offer sponsorship for employment status (including, but not limited to, H1-B visa status and other employment-based nonimmigrant visas for this position. Accordingly, all applicants must be currently authorized to work in the United States on a full-time basis and must not require The Coca-Cola Company's sponsorship to continue to work legally in the United States. Skills: Pay Range: $51,480 - $62,920 Base pay offered may vary depending on geography, job-related knowledge, skills, and experience. A full range of medical, financial, and/or other benefits, dependent on the position, is offered. Our Purpose and Growth Culture: We are taking deliberate action to nurture an inclusive culture that is grounded in our company purpose, to refresh the world and make a difference. We act with a growth mindset, take an expansive approach to what's possible and believe in continuous learning to improve our business and ourselves. We focus on four key behaviors - curious, empowered, inclusive and agile - and value how we work as much as what we achieve. We believe that our culture is one of the reasons our company continues to thrive after 130+ years. Visit Our Purpose and Vision to learn more about these behaviors and how you can bring them to life in your next role at Coca-Cola. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. When we collect your personal information as part of a job application or offer of employment, we do so in accordance with industry standards and best practices and in compliance with applicable privacy laws.

Posted 1 week ago

Tech/Render QA Engineer (World Of Warships: Legends)-logo
Tech/Render QA Engineer (World Of Warships: Legends)
Wargaming AmericaBelgrade, MT
Job Overview Wargaming is looking for a Tech/Render QA Engineer to work on World of Warships: Legends in our brand-new Belgrade office. World of Warships: Legends is the best naval game around, letting you take the command of legendary warships from the period of the 20th century as you battle your way across the open sea with other players. The project is driven by a team of international developers who combine talent with their passion for video games, resulting in World of Warships: Legends being a favorite hobby for millions all around the globe with keeping its community ever-growing! We are looking for an experienced Tech/Render QA Engineer with a deep understanding of game development processes, debugging and performance testing. If you are committed to improving product quality and are good at collaborating with a team, join us! What will you do? Quality control of features and content of the game in terms of functional and non-functional requirements Create and maintain up-to-date test documentation Create and execute test cases, checklists, and test plans Create clear and actionable bug reports and help resolve issues efficiently Handling bugs from all stages of the product Collaborate closely with the development team to support builds stability and optimize the game What are we looking for? Experience in QA 2+ years Ability to describe basic testing artifacts (maintaining documentation, creating test cases, checklists, bug reports) Ability to assess game performance, identify crashes, memory leaks and visual bugs Proficiency in debugging and troubleshooting across multiple platforms (PC, consoles, mobile) Ability to clearly and accurately describe identified issues Adaptability and a problem-solving mindset to adjust to changing priorities OS basics (Windows / Linux / Mac OS) Experience with any version control system (git, svn, etc.) Experience with any task and test case management system Expereince with performance measurement and analysis tools (e.g. PIX, Telemetry, Razor GPU/CPU etc.) Familiarity with tools for diagnosing client stability issues, including crash and hang investigation (WinDBG, Visual Studio) Proficiency with a wide range of tools for development, debugging, CI/CD, and test management: Android Studio, Xcode, Android GPU Inspector, RenderDoc, TeamCity, Jira + Confluence, TestRail, and Allure Strong communication skills Intermediate English level or higher What additional skills will help you stand out? Experience in GameDev Experience in mobile/console games/app testing Experience with any game engine (Unreal, Unity, Godot etc.) Render knowledge Advanced Russian language skills Work mode Hybrid (3 days of work from the office) Benefits Benefits and perks are tailored to the local market and culture. Our benefits in Belgrade include: Annual leave of 20 working days (additional days based on years of service at Wargaming: up to 25 days) Additional paid time off (5 Personal Days, Birthday Leave, Marriage Leave, Compassionate Leave) Sick Leave Compensation, Maternity Leave Benefits Premium Private Health Insurance Career development and education opportunities within the company English clubs and platform for learning languages Mental well-being program (iFeel) Commuting allowance Company events FitPass membership Discounts for employees Personal Gaming Account Coffee, fruits, and snacks in the office On-site canteen with subsidized prices for food and drinks Seniority Awards Referral program - you can recommend the best talents to the Company and receive a reward Please submit your CV in English to ensure smooth processing and review. About Wargaming Wargaming is an award-winning online game developer and publisher headquartered in Nicosia, Cyprus. Operating since 1998, Wargaming has become one of the leaders in the gaming industry with 15 offices worldwide, including studios in Chicago, Prague, Shanghai, Tokyo, and Vilnius. Our diverse and multicultural team works together to deliver a top-class experience to millions of players who enjoy Wargaming's titles across all major gaming platforms. Our flagship products include free-to-play hits World of Tanks, World of Warships and World of Tanks Blitz. Please see Wargaming Candidate Privacy Policy for details on how Wargaming uses your personal data.

Posted 30+ days ago

Assistant Manager QA-logo
Assistant Manager QA
Elanco Animal Health IncorporatedMumbai, IN
At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! As the Assistant Manager Quality Assurance for the Elanco external manufacturing (EEM), the responsibility is providing quality oversight of assigned contract manufacturing organizations (CMOs) and suppliers within Elanco's network in India. The primary responsibility of this position is to ensure the CMOs are compliant with relevant regulations and Elanco requirement, thereby ensuring products released to market are fit for intended use and meet all legal and Elanco requirements. As Assistant Manager QA, you need to drive and maintain improvements in the quality systems and processes, at CMOs, suppliers, and to provide advice on all quality and compliance matters. Responsibilities/ Duties/Tasks: Ensure that all marketed products are dispositioned in accordance with local regulations and Elanco requirements Drive the utilization of Quality Risk Management principles for contract manufacturing sites Ensure Quality activities of pharmaceutical products at identified CMOs to comply with the requirements of the Elanco Global standards and meet all relevant cGMP & regulatory requirements Manage and support change control, deviation, non-conformance and market complaint investigation at Elanco and contract manufacturing sites Manage Quality agreements with contract manufacturing site. Support and provide quality input for Qualification and validation activities at CMOs and product launches Management of Product Quality Reviews (PQR) of CMOs- Review of PQR, corrections/follow-up actions & monitoring of PQR trends Schedule and follow up on audits at contract manufacturing sites and suppliers and monitor the corresponding corrective actions in line with Elanco Global Compliance and Auditing team requirements/timelines Implement continuous improvement initiatives, quality management review and governance associated with quality system to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance Review of analytical data, chromatograms, specifications and method of analysis Manage QA related projects including analytical method transfers and validations in collaboration with cross functional team Manage stability program of products manufactured to ensure that products meet the specification up to its recommended shelf life Comply with all company local and global policies including Quality frameworks, code of conduct, anti-discrimination, harassment and health, safety and environment (HSE) policies Basic Requirements Education: M. Pharma, B. Pharma, M.Sc. Experience: Minimum 6 to 8 years of experience with exposure in shop floor manufacturing/QC laboratory who has led the team of 2 or more people in supervisory level Candidates with analytical (QC) background with experience in handling HPLC, GC, AMV and Stability shall be preferred Exposure of SAP and Quality Management System software will add advantage Exposure of working in a regulated market with audit exposure shall be preferred Exposure to packaging material will be added advantage. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Posted 30+ days ago

Senior QA Analyst, Product Engineering-logo
Senior QA Analyst, Product Engineering
Autodesk Inc.Portland, OR
Job Requisition ID # 25WD88334 Senior QA Analyst, Product Engineering Team Description The Autodesk Student Community team is dedicated to empowering the next generation of innovators and creators by providing comprehensive support and resources for secondary and post-secondary students. We oversee the product development, UX design, and engineering for Tinkercad's web services and community features, as well as the Instructables platform, ensuring both platforms offer valuable learning experiences and community engagement. Through these efforts, we support Autodesk's educational mission by equipping students with the skills and knowledge they need to excel in their academic and professional pursuits. Position Overview As a Senior QA Analyst/Release Manager in Product Engineering, you will play a pivotal role in ensuring the delivery of high-quality software solutions. You will work closely with product management, engineering, and marketing teams to oversee and monitor the quality and reliability of our products through rigorous testing, quality assurance processes, and effective release management. Your responsibilities will include collaborating with product managers, developers, and other stakeholders to develop and execute comprehensive test plans, meticulously identifying and documenting defects, and ensuring that our products meet the highest standards of quality. Additionally, you will manage the release process, ensuring smooth and timely delivery of software updates and new features. Your expertise and attention to detail will be critical in delivering exceptional software solutions that align with Autodesk's commitment to innovation and excellence. Key Responsibilities Develop and implement comprehensive QA strategies and processes to ensure the highest quality standards for our products Create detailed test plans and test cases based on product requirements and specifications Conduct both manual and automated testing to identify and document defects, ensuring thorough coverage of all product features Identify, document, and report defects found during testing, providing detailed information to facilitate resolution Develop and maintain release schedules, coordinating with various teams to ensure alignment and readiness. Monitor and analyze product performance and reliability post-release, addressing any issues that arise. Continuously improve QA processes and practices to enhance product quality and team efficiency. Minimum Qualifications Proven experience in developing and implementing successful QA strategies and processes Proficiency in manual and automated testing tools and frameworks (e.g Playwright, Selenium, JIRA, TestRail) Proven experience with various testing methodologies, including manual, automated, functional, regression, and performance testing Strong experience in developing and maintaining automated test scripts Strong analytical skills with the ability to troubleshoot complex issues and provide detailed analysis and recommendations Preferred Qualifications 8+ years of experience in quality assurance, with a focus on product engineering, preferably within the SaaS sector Bachelor's or advanced degree in Computer Science, Engineering, or a related field Skills Develop QA strategies: Ability to create and implement comprehensive QA strategies and processes to ensure the highest quality standards for our products Release Management: Experience in managing the release process, including planning, scheduling, and controlling the movement of releases to the test and live environments. Ensuring that the integrity of the live environment is protected and that the correct components are released. Plan and conduct tests: Expertise in creating and executing detailed test plans and test cases based on product requirements and specifications Document QA activities: Skilled in maintaining detailed documentation of test plans, test cases, and test results Manage Bug Tracking & Test Management Tools: Proficiency in using bug tracking and test management tools such as JIRA, Bugzilla, TestRail, or Quality Center Leverage testing methodologies: Proficiency in various testing methodologies, such as manual testing, automated testing, regression testing, and performance testing #LI-RR2 Learn More About Autodesk Welcome to Autodesk! Amazing things are created every day with our software - from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made. We take great pride in our culture here at Autodesk - our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers. When you're an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us! Benefits From health and financial benefits to time away and everyday wellness, we give Autodeskers the best, so they can do their best work. Learn more about our benefits in the U.S. by visiting https://benefits.autodesk.com/ Salary transparency Salary is one part of Autodesk's competitive compensation package. For U.S.-based roles, we expect a starting base salary between $110,300 and $190,300. Offers are based on the candidate's experience and geographic location, and may exceed this range. In addition to base salaries, we also have a significant emphasis on annual cash bonuses, commissions for sales roles, stock grants, and a comprehensive benefits package. Equal Employment Opportunity At Autodesk, we're building a diverse workplace and an inclusive culture to give more people the chance to imagine, design, and make a better world. Autodesk is proud to be an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender, gender identity, national origin, disability, veteran status or any other legally protected characteristic. We also consider for employment all qualified applicants regardless of criminal histories, consistent with applicable law. Diversity & Belonging We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging Are you an existing contractor or consultant with Autodesk? Please search for open jobs and apply internally (not on this external site).

Posted 30+ days ago

Director, QA Engineering-logo
Director, QA Engineering
CodaMetrixBoston, MA
CodaMetrix is revolutionizing Revenue Cycle Management with its AI-powered autonomous coding solution, a multi-specialty AI-platform that translates clinical information into accurate sets of medical codes. CodaMetrix's autonomous coding drives efficiency under fee-for-service and value-based care models and supports improved patient care. We are passionate about getting physicians and healthcare providers away from the keyboard and back to clinical care. Job Description The Director, QA Engineering will lead the quality engineering strategy for the Core Engineering team, fostering a culture of continuous improvement, automation, and scalability across the Core Engineering QA organization. This individual will be responsible for building and nurturing a high-performing QA team, establishing effective quality standards, and collaborating with cross-functional leaders to ensure the release of high-quality products. They will drive the QA vision to align with CI/CD and DevOps initiatives, balancing technical depth with strategic foresight. Responsibilities Develop and lead the Core Engineering QA strategy, ensuring alignment with business goals and promoting a proactive quality culture. Drive key initiatives in CI/CD, automation, and quality standards across all Core Engineering development teams. Hire, mentor, and manage a team of QA engineers and QA managers. Foster a collaborative, innovative, and inclusive environment that empowers team members to excel. Establish, evolve, and advocate for automation frameworks, tools, and processes to support CI/CD pipelines, automated testing, and test coverage. Ensure that our automation strategy scales with our growing product portfolio. Build and optimize QA processes, focusing on efficiency, scalability, and risk management. Implement best practices for unit, integration, and end-to-end testing, aligned with agile methodologies. Collaborate with Engineering, Product Management, and DevOps to design and implement test strategies early in the development lifecycle. Act as a QA advocate to ensure testing needs are addressed throughout the SDLC. Define and track QA metrics to measure quality, productivity, and process efficiency. Communicate insights and drive improvements in defect prevention and test accuracy. Stay updated with industry trends, emerging technologies, and best practices. Proactively implement improvements that ensure our quality engineering practices remain cutting-edge and impactful. Skills & Experience Bachelor's degree in Computer Science, Engineering, or a related field; advanced degree is a plus. 10+ years in quality engineering, with at least 5 years in a leadership role managing QA teams. Proven track record of implementing QA strategies in CI/CD and agile environments. 2+ years of experience in web-based software development within the healthcare IT industry. Strong understanding of test automation frameworks (e.g., Selenium, Cucumber), CI/CD pipelines, cloud-based testing, and QA tools. Extensive experience in building and testing microservices, ensuring reliable, scalable quality assurance practices are applied to service-oriented architectures. Proficient in Behavior Driven Testing and Design, with hands-on experience implementing BDD/BDT methodologies to improve test clarity and collaboration between QA and development teams. Skilled in using open source tools like Git for version control, Jenkins for CI/CD integration, and SonarQube for code quality and security analysis. Strong understanding of REST architecture with demonstrated experience in testing and automating REST APIs, ensuring robust and reliable service interactions. In-depth experience using testing frameworks like TestNG, JUnit, and tools such as Cucumber or Litmus to facilitate unit, integration, and behavior-driven testing. Skilled in automation scripting with Python or a comparable language, enabling the development of custom test scripts and enhancing automation capabilities. Demonstrated experience building, mentoring, and scaling high-performing QA teams. Excellent leadership and communication skills, with a track record of successful cross-functional collaboration. Strategic thinker with a hands-on approach to problem-solving, particularly in complex systems and large-scale testing environments. The estimated hiring range for this role is $185,000 - $225,000 (plus applicable bonus/plus equity). This hiring range could vary by region based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. What CodaMetrix can offer you: Learn more about our full-time employee benefits and how we take care of our team. Health Insurance: We cover 80% of the cost of medical and dental insurance and offer vision insurance Retirement: We offer a 401(k) plan that eligible employees can contribute to one month after their first day Flexibility: We have a generous Paid Time Off policy, which is managed but not limited, so you can take the time you need to relax and rejuvenate Learning: All new hires complete our 7-week Onboarding Program where they learn about our company and each of our departments through live sessions hosted by a variety of our leaders Development: We provide annual performance evaluations and prioritize working with employees on what their individual growth looks like Recognition: We recognize the outstanding achievements of our team through annual company awards where employees have the opportunity to nominate their peers Office Location: A modern open plan workspace located in the bustling Back Bay neighborhood of Boston Additional Employer Paid Benefits: We offer employer-paid life insurance and short-term and long-term disability insurance Background Check Notice All candidates will be required to complete a background check upon acceptance of a job offer. Equal Employment Opportunity Our company, as well as our products, are made better because we embrace diverse skills, perspectives, and ideas. CodaMetrix is an Equal Employment Opportunity Employer and all qualified applicants will receive consideration for employment. Don't meet every requirement? We invite you to apply anyway. Studies have shown that women, communities of color and historically underrepresented talent are less likely to apply to jobs unless they meet every single qualification. At CodaMetrix we are committed to building a diverse, inclusive and authentic workplace and encourage you to consider joining us.

Posted 1 week ago

CSL Global logo
QA Auditor
CSL GlobalEMEA, DE
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Job Description

Für die Abteilung Qualitätssicherung CSL Plasma in Göttingen suchen wir ab sofort einenMitarbeiter (m/w) im Qualitätsmanagement zur Ausbildung zum GxP-Auditor mit sehr guten Sprachkenntnissen in Deutsch, Italienisch, Französisch oder Spanisch (verhandlungssicher)

(Vollzeit / befristet)Ihre Tätigkeiten:

  • Unterstützung der Teamleitung in der Betreuung und Qualifizierung von Plasmalieferanten / Dienstleistern im Europäischen Raum
  • Vorbereitung der Audits inklusive Reiseorganisation
  • Durchführung von Qualifizierungsaudits bei Plasmalieferanten / Dienstleistern nach GxP im Europäischen Raum,
  • Überprüfung der Compliance im Hinblick auf regulatorische und gesetzliche Vorgaben
  • Evaluierung der Auditergebnisse, Durchführung von Risikoanalysen und Bewertung der Auswirkungen auf den Qualifizierungsstatus des Plasmalieferanten / Dienstleisters; Bewertung der korrektiven / präventiven MaßnahmenIhr Profil:
  • Erfolgreich abgeschlossene Berufsausbildung oder abgeschlossenes Bachelorstudium im Gesundheitswesen oder im naturwissenschaftlichen Bereich; 2 - 3 Jahre Berufserfahrung wünschenswert;
  • Fundierte Kenntnisse im Qualitätsmanagement und GxP-Bereich sowie Audit-/Inspektionserfahrung von Vorteil;
  • Sicherer Umgang mit MS-Office-Standardsoftware;
  • Bereitschaft zu intensiver Reisetätigkeit mit einem hohen Maß an Flexibilität;
  • Analytisches und lösungsorientiertes Denkvermögen sowie strukturierte und selbständige Arbeitsweise;
  • Team- und Konfliktfähigkeit sowie sehr gute Umgangsformen;
  • Weitere Fremdsprachenkenntnisse wünschenswert;

Ihre Benefits:

  • Eine betriebliche Spezial-Ausbildung zum GxP-Auditor;
  • Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung;
  • Abwechslungsreiches sowie anspruchs- und verantwortungsvolles Aufgabengebiet;
  • Angenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken Team;
  • Eine attraktive Vergütung mit zusätzlicher Altersversorgung;

Ihre aussagekräftige Bewerbung richten Sie bitte an:

CSL Plasma GmbH, PSCQ_SQ, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder

per Email an ute.cherfan@cslplasma.com

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

About CSL Plasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Plasma!