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QA Engineer II-logo
QA Engineer II
Grow TherapyNew York City, NY
About the Role: Our engineering teams are looking for a QA Engineer with a strong background in the software development life cycle. You'll help Grow Therapy providers and clients with the data, tools, and support they need to establish deep connections with each other, to unlock lifelong mental health support, and drive positive mental health outcomes. This is an exciting opportunity for a passionate, mission-aligned QA engineer to make an immediate impact on our rapidly scaling team. What You'll Be Doing: Maintain and improve the quality and reliability of the application through daily smoke testing and exploratory testing Collaborate with cross-functional stakeholders to build out and run test plans for large feature launches Identify improvements in company QA processes to improve overall software development life cycle Own end to end defect tracking and resolution processes Serve as the subject matter expert on team's surface area and how it interacts with other team surface areas You'll Be a Good Fit If You Have: 3+ years of proven QA experience, ideally in a high-growth, fast-paced environment. You pride yourself on your attention to detail and easily can put yourself in user shoes to ensure we are providing a best in class experience our users deserve. You have a strong bias for action and can drive value with little to no guidance. You enjoy communicating effectively and building relationships with both technical and non-technical stakeholders. You welcome ambiguity and leverage structured thinking to solve problems. Nice to Have's: Prior experience working across multiple engineering teams. QA automation experience. Experience testing AI-driven features or using modern AI tools to boost your productivity. Exposure to health-tech data / EHR integrations. If you don't meet every single requirement, but are still interested in the job, please apply. Nobody checks every box, and Grow believes the perfect candidate is more than just a resume. Salary range: $120,000-$140,000 Please Note: This role is based out of the New York City metropolitan area, the San Francisco Bay Area, or the Greater Seattle area. We use Covey as part of our hiring and / or promotional process for jobs in NYC and certain features may qualify it as an AEDT. As part of the evaluation process we provide Covey with job requirements and candidate submitted applications. We began using Covey Scout for Inbound on January 11, 2025. Please see the independent bias audit report covering our use of Covey here.

Posted 1 week ago

Construction Qa/Qc Specialist - Disaster Recovery-logo
Construction Qa/Qc Specialist - Disaster Recovery
ICF International, IncTallahassee, FL
Join the ICF team and make a difference! Our growing Disaster Management Division makes BIG things happen every day. ICF is seeking a Construction QA/QC Specialist to assist the State of Florida with managing federal disaster recovery grant programs and carrying out strategic, high-impact activities to rebuild housing, strengthen communities, and mitigate future disaster risks. The Construction QA/QC Specialist will perform day-to-day quality assurance and quality control activities to support residential construction, rehabilitation, reconstruction, and mitigation efforts funded through the Community Development Block Grant- Disaster Recovery (CDBG-DR) and Community Development Block Grant- Mitigation (CDBG-MIT) programs. This position requires a strong attention to detail, critical thinking, and the ability to adjust to an ever-changing environment. Key Responsibilities: Perform QA/QC reviews of inspection reports, scopes of work, cost estimates, builder invoices, and milestone inspections. Verify that all construction documentation is accurate, complete, and consistent with approved project scopes. Ensure environmental compliance requirements (lead-based paint, asbestos, mold, Section 106 compliance) are properly incorporated into scopes of work. Review and validate builder invoice submissions for accuracy, completeness, and cost reasonableness. Assist in maintaining document control and proper filing of all construction and inspection documentation in the system of record. Coordinate with Damage Assessors, Construction Managers, and other field staff to resolve inconsistencies and deficiencies in construction documentation. Support quality assurance audits, inspections, and field verification activities as needed. Identify potential risks or discrepancies and escalate findings to the Construction QA/QC Lead for resolution. Other tasks, as assigned. Minimum Qualifications: Associate's degree or equivalent combination of education and relevant work experience. 1-3 years of experience supporting residential construction, inspections, damage assessments, or QA/QC activities. Experience working with CDBG-DR, CDBG-MIT, or other federally funded construction programs. Proficiency with Xactimate X or later versions for damage assessments and cost estimating. Knowledge of IRC 2021, IBC 2021, Florida Building Code, and resilient residential construction practices. Strong proficiency in Microsoft Excel, Word, and document management systems (e.g., SharePoint, QuickBase, Salesforce). Excellent organizational skills and attention to detail. Ability to manage multiple tasks simultaneously and work independently or collaboratively within a team environment. Other Job Details: Remote position with possible occasional travel to field offices, client sites, and housing centers throughout Florida. Full-time position. "This job is a Section 3 eligible job opportunity. We encourage applications from individuals that are low income and/or living in Public Housing." Working at ICF ICF is a global advisory and technology services provider, but we're not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future. We can only solve the world's toughest challenges by building a workplace that allows everyone to thrive. We are an equal opportunity employer. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO policy. Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation, please email Candidateaccommodation@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about workplace discrimination rights or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act. Candidate AI Usage Policy At ICF, we are committed to ensuring a fair interview process for all candidates based on their own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) tools to generate or assist with responses during interviews (whether in-person or virtual) is not permitted. This policy is in place to maintain the integrity and authenticity of the interview process. However, we understand that some candidates may require accommodation that involves the use of AI. If such an accommodation is needed, candidates are instructed to contact us in advance at candidateaccommodation@icf.com. We are dedicated to providing the necessary support to ensure that all candidates have an equal opportunity to succeed. Pay Range- There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position based on full-time employment is: $66,701.00 - $113,391.00 Florida Remote Office (FL99)

Posted 30+ days ago

Software QA Automation Manager-logo
Software QA Automation Manager
BoseFramingham, MA
You know the moment. It's the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying "hello." It's in these moments that sound matters most. At Bose, we believe sound is the most powerful force on earth. We've dedicated ourselves to improving it for nearly 60 years. And we're passionate down to our bones about making whatever you're listening to a little more magical. The Engineering team at Bose is a thriving, passionate, deeply skilled team of professionals from a broad range of disciplines and experiences, who share a common goal-to create products that provide transformative sound experiences. Job Description Think you know Bose? Look closer. We've spent more than 60 years finding new ways to bring quality audio products to people-in their homes, in cars, planes, and just about anywhere else that there is a possibility to enjoy music. Our legendary QuietComfort noise cancelling headphones, SoundLink Mini Bluetooth speaker, or Wave music system may ring a bell with you. Bose relies on exceptional people to create and deliver those products to our customers. The future of consumer electronics at Bose isn't just about our award-winning speakers or headphones. It is about the consumer experience as enabled by product features and service offerings. It is about making everyday life easier and more enjoyable. It's about connected products to consumer's world including social media, entertainment and communications. Helping people reach their fullest human potential - so they can feel more, do more and be more. At Bose, we're obsessed with delivering amazing experiences through superior technology and design. When you join our team, you'll work with Bose products to delight millions of customers around the globe for years to come. This is a unique opportunity to do the most impactful work of your career. Today, we're focused on enriching everyday life through connected, intelligent, and immersive product experiences. Our vision blends exceptional design, intuitive software, and meaningful technology. And none of it happens without incredible people. About the Role The Software QA Automation Manager will lead the transformation of our automation team-elevating test practices, scaling automation infrastructure and mentoring top talent. You'll work on some of Bose's most iconic and innovative products-including headphones, earbuds, Bluetooth speakers and home theater systems-and play a key role in improving software quality across Bluetooth devices and mobile platforms. This is your chance to modernize how we test and make a big impact on how millions of people experience sound. What You'll Do Lead & Inspire Manage and mentor a growing team of QA automation engineers Foster a culture of ownership, learning, and continuous improvement Modernize QA Redesign and scale test automation frameworks Introduce smart, reliable test strategies for fast feedback and early defect detection Collaborate Across Teams Partner with developers, architects, product owners, and other QA leaders Integrate quality into all phases of the software development lifecycle Own Automation Strategy Develop test plans, define appropriate test suites, and build tools to test functionality, performance, and stability Drive test execution and reporting with tools like Jenkins, TestRail, and AWS Champion Quality Promote best practices in CI/CD and automated regression Ensure robust validation of Bluetooth connectivity and mobile interactions (iOS, Android) Track Progress Implement and report on quality KPIs Provide clear status updates and risk assessments Qualifications: B.S. in Computer Science or equivalent 10+ years' industry experience in QA or Software Engineering 15+ years' experience designing, implementing, and executing automated tests 5+ years of people management Experience with Python and other scripting languages Experience using common automation frameworks Familiarity with version control, bug tracking, and CI / CD systems and procedures Expertise with Bluetooth, WiFi, or other networking protocols. Experience with basic lab equipment (Bluetooth analyzers) Keen sense of ownership, passionate, fast learner, detail-oriented, analytical mindset, perfection seeker Strong oral and written communication skills Experience with Android, iOS, or other mobile application development or testing Bose is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics. The EEOC's "Know Your Rights: Workplace discrimination is illegal" Poster is available here: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf . Bose is committed to providing reasonable accommodations to individuals with disabilities. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to applicant_disability_accommodationrequest@bose.com. Please include "Application Accommodation Request" in the subject of the email. Our goal is to create an atmosphere where every candidate feels supported and empowered in the interviewing process. Diversity and inclusion are integral to our success, and we believe that providing reasonable accommodation is not only a legal obligation but also a fundamental aspect of our commitment to being an employer of choice. We recognize that individuals may have different needs and requirements based on their abilities, and we provide reasonable accommodations to ensure ideal conditions are met during the application process.

Posted 2 weeks ago

QA Engineer 3-logo
QA Engineer 3
Onto InnovationBudd Lake, NJ
Onto Innovation is a leader in process control, combining global scale with an expanded portfolio of leading-edge technologies that include: 3D metrology spanning the chip from nanometer-scale transistors to micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for advanced semiconductor packaging. Our breadth of offerings across the entire semiconductor value chain helps our customers solve their most difficult yield, device performance, quality, and reliability issues. Onto Innovation strives to optimize customers' critical path of progress by making them smarter, faster and more efficient. Job Summary & Responsibilities Position Summary: Onto Innovation, Inc. is a worldwide leader in the design, development, manufacture and support of defect inspection, advanced packaging lithography, process control metrology, and data analysis systems and software used by microelectronic device manufacturers worldwide. We are seeking a motivated Junior System SQA Engineer to join our team to develop cutting edge solutions for semiconductor metrology tool platforms. This team is responsible for the development of advanced electromechanical systems utilizing optics, robotics, image processing, and control systems. The position will be in Budd Lake, New Jersey. The role will cover all aspects of system quality, including translating customer requirements into system validation plans, developing coverage analysis, and automated testing for semi-industry equipment. This is a fantastic opportunity to engage in a positive and creative work environment that offers excellent benefits. Must be onsite 5 days/week in Budd Lake, NJ. No relocation being offered at this time. Roles and Responsibilities: Contribute to development and execution of system test plans Translate customer requirements into system validation plans Execute existing software test plans and system-level validation plans Recommend improvements to existing software validation process as necessary Understand metrology tool platforms and technologies from a systems perspective Demonstrate effective communication skills within a diverse team Qualifications BS degree in Computer Science/Computer Technology 1-3 years' experience as a QA engineer Developing test strategies and creating appropriate test plans based on high-level requirements Responsible for assuring that output from the software development process includes adequate identification and interpretation of product requirements, such as a) traceability requirements, b) test requirements, c) usability Supports QA with product rollouts Knowledge of software development lifecycle testing methodologies (black box, white box) and test automation tools. Experience with hardware control and configuration Experience with Automated Testing Tools/Techniques is a plus Excellent teamwork and communication skills Strong time management skills and organizational skills Knowledge of agile SCRUM methodology, configuration management, and Azure DevOps Electromechanical systems, SEMI capital equipment a plus Onto Innovation Inc. offers competitive salaries and a generous benefits package, including health/dental/vision/life/disability, PTO, 401K plan with employer match, and an Employee Stock Purchase Program (ESPP) along with health & wellness initiatives. We provide a collaborative working environment along with resources, and state-of-the-art tools & equipment to promote success; and a welcoming, inclusive corporate culture where individuals are recognized for their contributions. Onto Innovation Inc. is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, genetic information, age, disability, veteran status, or any other legally protected basis. For positions requiring access to technical data, Onto Innovation Inc., Inc. may have to obtain export licensing approval from the U.S. Department of Commerce- Bureau of Industry and Security and/or the U.S. Department of State- Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.

Posted 30+ days ago

Senior QA Engineer-logo
Senior QA Engineer
Veeva SystemsPleasanton, CA
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva Systems is looking for a functional Senior QA Engineer with black box and automation testing experience to join our rapidly growing team. This is a hands-on position for delivering quality SaaS applications in the Commercial space into production. What You'll Do Ability to work in an agile, small team environment with a focus on speed and quality Create testing-related documentation, including test plans, test cases/scripts, and bug reports assessing quality and associated risk Mentor junior SQAs in QA methodologies and skills Work closely with the automation group to automate features for better regression coverage Develop deep expertise in the product Conduct QA tests and verify outcomes within schedules/timelines Work with software engineers, product managers, and other QA testers in an Agile team environment Requirements 7+ years of relevant work experience as a functional QA Engineer Strong verbal and written communication skills Understanding of Software QA methodologies, tools, and approaches (black box and grey box testing) in a software company with short release cycles Experience in writing test cases, covering both sanity and in-depth testing, including and not limited to boundary, negative, compatibility, and concurrency tests Strong verbal and written communication skills Bachelors/Master's degree in Computer Science, Software Engineering, or equivalent experience Knowledge of testing Windows desktop platform applications (based on Delphi or C# or similar) Knowledge of JIRA, TestRails Knowledge of testing desktop-to-web integration applications Knowledge of testing desktop GIS applications Location in the Pacific time zone required. Applicants must have the unrestricted right to work in the United States. Veeva will not provide sponsorship at this time. Nice to Have Experience with Jira, Confluence, and TestRail Experience in a SaaS environment that has an agile development process User-level knowledge of MS Access or MS SQL Server or similar (open tables, run queries) Knowledge of TestComplete test automation tool (for Delphi or C# or similar) Knowledge of InstallAware or Wise for creating Installation packages for desktop applications (based on Delphi or C# or similar) Basic knowledge of languages: SQL, Python, Delphi (or C#), REST JSON Basic knowledge of GIT Knowledge of MS Office, GMail, Mattermost Perks & Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs 1% charitable giving program Compensation Base pay: $80,000 - $150,000 The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus. #LI-Remote Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.

Posted 3 weeks ago

Clinical Research QA Specialist - Cancer & Blood Diseases Institute (Hybrid)-logo
Clinical Research QA Specialist - Cancer & Blood Diseases Institute (Hybrid)
Cincinnati Children's Hospital Medical CenterCincinnati, OH
Job Description At Cincinnati Children's, we come to work with one goal: to make children's health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children's. Cincinnati Children's is: Recognized by U.S. News & World Report as a top 10 best children's hospitals in the nation for more than 15 years Second Among All Children's Hospitals for National Institutes of Health (NIH) Funding Recognized as one of America's Best Large Employers (2025) , America's Best Employers for New Grads (2024) One of the nation's America's Most Innovative Companies as noted by Fortune Consistently certified as great place to work A Leading Disability Employer as noted by the National Organization on Disability Magnet designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC) JOB RESPONSIBILITIES Data and Documentation- Review and analyze clinical trial data and related documentation (internal and external). Provide guidance to clinical faculty and staff in clinical research documentation clinical trials. Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs. Develop and communicate outcome measures. Monitoring- Develop comprehensive data safety monitoring plans for all clinical trial activities within the assigned department to ensure that trials are conducted in compliance with the protocol, SOPs, ICH GCP, federal, state, and local regulatory requirements. Prepare and execute monitoring plans both internally and at affiliate sites, including site visits to ensure protocol and regulatory compliance; data management tasks to ensure study data integrity; verify essential documents are accurate, complete, and maintained; and coordination of applicable follow-up activities. Assist in the development and implementation of action plans for external monitoring/audit follow-up. Assist in preparation and conduct of audits/surveys/inspections by FDA, DHHS, institutional, and accreditation agencies. Develop improvement plans using quality improvement methods (process improvement, continuous improvement, total quality management, etc.). Protocols- Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers. Participate in the development of investigator-led protocols, e.g., data safety monitoring plans. Develop and maintain SOPs for clinical trials. Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested. Training- Assist in developing and providing clinical trial training and consultation for faculty, staff, and affiliate sites. Provide training (ICH GCP, FDA, DHHS, state, local, and institutional) and/or other training initiatives to faculty and staff, as assigned. JOB QUALIFICATIONS Bachelor's degree in a related field 2+ years of work experience in a related job discipline SoCRA or ACRP within 18 months of external hire Market Leading Benefits Including*: Medical coverage starting day 1 of employment. View employee benefits here. Competitive retirement plans Tuition reimbursement for continuing education Expansive employee discount programs through our many community partners Shift Differential, Weekend Differential, and Weekend Option Pay Programs Referral bonus program for current staff! Support through Employee Resource Groups such as African American Professionals Advisory Council, Asian Cultural and Professional Group, EQUAL - LGBTQA Resource Group, Juntos- Hispanic/Latin Resource Group, Veterans and Military Family Advocacy Network, and Young Professionals (YP) Resource Group Physical and mental health wellness programs Relocation assistance available for qualified positions Benefits may vary based on FTE Status and Position Type Primary Location Burnet Campus Schedule Full time Shift Day (United States of America) Department Cancer & Blood Disease Inst Employee Status Regular FTE 1 Weekly Hours 40 Expected Starting Pay Range Annualized pay may vary based on FTE status $55,785.60 - $69,076.80 Comprehensive job description provided upon request. Cincinnati Children's is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability

Posted 2 weeks ago

QA Design Development Project Manager Job Details | Coloplast A/S-logo
QA Design Development Project Manager Job Details | Coloplast A/S
ColoplastNieder-Olm, DE
Die Tracoe Medical GmbH mit Hauptsitz und Produktionsstätte in Nieder-Olm (Rheinland-Pfalz) gehört zu den führenden Entwicklern und Herstellern von Medizinprodukten und Hilfsmitteln für Patienten mit Luftröhrenschnitt. Der Schwerpunkt des Premiumproduktportfolios liegt auf Tracheostomiekanülen und Zubehör zur Patientenversorgung in der Klinik wie auch im HomeCare-Bereich. Tracoe Medical ist seit 2021 bzw. 2022 ein Unternehmen der Atos Medical / Coloplast Gruppe und beschäftigt insgesamt rund 300 Angestellte am Standort Nieder-Olm. Das Unternehmen blickt auf eine 60-jährige Geschichte zurück und wurde bereits dreimal in die Top 100 des Deutschen Mittelstands gewählt. DE - Stellenausschreibung Zur Verstärkung unseres Teams suchen wir zum nächstmöglichen Termin einen Quality Assurance Design Development Project Manager (m/w/d) Stellenumfang: Vollzeit, 40 Wochenstunden Standort: TRACOE medical GmbH, Nieder-Olm / Deutschland Deine Hauptaufgaben: Repräsentation der Qualitätssicherung in allen Entwicklungsprojektteams und stellt sicher, dass das in der Entwicklung befindliche Produkt den relevanten Entwicklungsprozessen (d.h. Designkontrolle, Risikomanagement, HF-Engineering) sowie den geltenden technischen Normen und Vorschriften entspricht Überprüfung und Genehmigung der gesamten DHF-relevanten Dokumentation, die während des gesamten Design-, Entwicklungs- und Lebenszyklus erstellt wird Leitung und Unterstüztung von Projektteams bei der Anwendung von Best Practices im Dokumentenmanagement (GDP) Bereitstellung von Qualitätssicherung, Überwachung und Beratung bei allen technischen, Risikomanagement- und Human-Factors-Aktivitäten während der Entwicklungsprojekte, d. h. potenziell vom frühen Scoping/der Machbarkeit über die Entwicklung bis hin zum Designtransfer und der Industrialisierung Unterstützung bei qualitätsbezogenen (Sicherungs-)Aspekten von Innovationsprojekten sowohl intern als auch mit externen Kunden und Entwicklungspartnern Aufbau und Pflege von Schnittstellen zu Qualitätsmanagementeinheiten in der Produktion/im Betrieb, wie z. B. der Produktionstechnik für die Prozessvalidierung und der Qualitätskontrolle für die Validierung und Durchführung von Prüfverfahren Unterstützung bei der Umsetzung von entwicklungsrelevanten Quality by design Konzepten (Regelstrategie) Kooordinierung und Unterstützung bei der Umsetzung von internen Service Level Agreements Leitung und Überwachung des Änderungs- und Abweichungsmanagement während der Entwicklung und darüber hinaus Mitwirkung im change control Prozess bei dem Approval von Change Plans & bearbeitung Change Actions im bereich Quality Assurance Eigenverantwortliche Leitung und/oder nimmt an Design Reviews im Zusammenhang mit der Entwicklung neuer Produkte und nachhaltiger technischer Aktivitäten teil. Deine Qualifikation: Diplom-, Master- oder Bachelor-Abschluss in Medizinprodukten, Biologie oder Chemie, Chemie, Maschinenbau oder Biomedizintechnik, Kenntnisse der Vorschriften für Medizinprodukte in Bezug auf Qualitätssysteme wie ISO 13485, CFR 820.30 Kenntnisse der Vorschriften für Medizinprodukte in Bezug auf internationale regulatorische Auflagen wie MDD 93/42/ECC, MDR 745/2017, IVDR 746/2017. Grundkenntnisse in Human Factor Engineering und Risikomanagement gemäß IEC 62366 & ISO 14791 Praktische Erfahrung mit der Entwicklung, Industrialisierung und dem Lebenszyklusmanagement von Medizinprodukten Erfahrung im Bereich Qualitätsmanagement, -sicherung und -kontrolle Fließende Kenntnisse in Deutsch und Englisch, in Wort und Schrift Sehr gute MS-Office-Kenntnisse Deine persönlichen Skills: Fähigkeit zur Zusammenarbeit mit internationalen Partnern oder Teams, fließend in Wort und Schrift in Englisch und Deutsch Proaktiv mit guten Kommunikations- und Selbstmanagementfähigkeiten, ergebnisorientiert Durchsetzungsvermögen selbsständige, effiziente und sorgfältige Arbeitsweise, Flexibilität zur Arbeit als Teamplayer und Moderator nach Bedarf Starkes Engagement, Initiative und Pflichtbewusstsein Erfahrung in der Arbeit in einem internationalen Umfeld Reisebereitschaft Wir bieten dir: Einen sicheren und verantwortungsvollen Arbeitsplatz in einem erfolgreichen Team Eine Willkommenskultur und strukturierte Einarbeitung Ein freundliches Arbeitsklima und Kollegen, die Ihnen auf Augenhöhe begegnen Ideenmanagement, Freiraum zur Mitgestaltung von Prozessen und selbständiges Arbeiten Aktive Förderung Ihrer fachlichen und persönlichen Weiterbildung durch interne und externe Fortbildungsangebote Flexible Arbeitszeitmodelle und die Möglichkeit zum mobilen Arbeiten (bis zu 2 Tage pro Woche) Firmenevents, kostenfreie Parkplätze uvm. Haben wir Ihr Interesse geweckt? Machen Sie den ersten Schritt und bewerben Sie sich auf der Karriereseite unserer Homepage mit einem Klick über "Apply now". ____ EN - Job Advertisement To strengthen our team, we are looking for the next possible date for a Quality Assurance Design Development Project Manager (m/w/d) Job scope: Vollzeit, 40 Wochenstunden Loation: TRACOE medical GmbH, Nieder-Olm / Deutschland Key Responsibilities: Represents Quality Assurance in all development project teams, ensuring the compliance of the product under development to relevant development processes (i.e design control, risk management, HF engineering) as well as applicable technical standards and regulations Reviews and approvals of all the DHF relevant documentation generated all along design and development and lifecycle Guides and supports project teams in document management best practices (GDP) Provides Quality assurance, oversight and consultancy in all technical, risk management and human factors activities during development projects, i.e. potentially from early scoping/feasibility through development until design transfer and industrialization Supports in quality (assurance) related aspects with innovation projects internally as well as with external customers and development partners Builds up and maintains interfaces with quality management units in production/operation such as production engineering for process validation and quality control for test method validation and executionSupports the implementation of Quality by design concepts relevant for development (control strategy) Coordinates and supports the implementation of internal service level agreements if required Lead/supervises the change & deviation management during development and beyond Chairs and/or participate in Design Reviews related to new product development and sustaining engineering activities. Support within Change control Activities for Change plan Approval and Quality support in Change Controls Qualifications: Diploma or Masters or bachelor's degree in medical Devices, Biology or Chemistry, chemical, mechanical or biomedical engineering, Knowledge of medical devices regulations concerning quality system such as ISO 13485, CFR 820.30 Knowledge of medical devices regulations concerning international regulatory constrains such as MDD 93/42/ECC, MDR 745/2017, IVDR 746/2017. Basic knowledge on Human Factor Engineering and Risk Management according to IEC 62366 & ISO 14791 Hands-on experience with medical devices development, industrialization and life cycle management Experience in quality management, assurance and contrl Fluent in German and English Excellent MS Office skills Personal Skills: Ability to work with international partners or teams, fluent in written and spoken English and German Proactive with good communication and self management skills, result orientated Assertiveness, works efficient and diligent, with an independent, flexible approach as a team player and moderator as required Willingness to travel We offer you: A secure and responsible job in a successful team A welcoming culture and structured induction programme A friendly working atmosphere and colleagues who treat you as equals Idea management, freedom to help shape processes and work independently Active promotion of your professional and personal development through internal and external training programmes Flexible working time models and the option of mobile working (up to 2 days per week) Company events, free parking and much more... Have we piqued your interest? Take the first step and apply on the careers page of our homepage by clicking on 'Apply now'. Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox, Provox Life and Tracoe. We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business. Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma. Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S 58842 #LI-AT

Posted 3 weeks ago

QA Technician- Night Shift-logo
QA Technician- Night Shift
Milk SpecialtiesFond Du Lac, WI
At Actus Nutrition, our focus is to create high-quality ingredients designed to optimize health and nutrition. We are passionate and dedicated people. Each day, we collectively explore new, innovative ways to enhance product performance and value through our broad human and animal nutrition portfolios. We offer a comprehensive benefits package which includes medical, dental, vision and life insurance as well as a healthy 401(k) company match program. The Quality Tech has the responsibility for performing analytical procedures on raw materials, in-process samples and finished products as well as assisting with investigation and resolution of operational product issues. Shift: Night Shift- 6:00PM to 6:00AM Pay: $22.00 and up based on experience ESSENTIAL DUTIES and RESPONSIBILITIES: Conduct and interpret lab tests. Package and prepare samples for shipment to third party testing locations. Respond to internal calls to answer technical product questions. Perform laboratory computations leading to accurate data reporting. Troubleshoot lab issues. Conduct routine maintenance on all lab equipment. Contact lab supply vendors. Assist inventory control process. Ensure all laboratory chemical MSDSs are reviewed and filed. Read and properly interpret documents such as lab results, GMP manuals, HACCP programs and procedure manuals. Solve practical problems and comfortably deal in high pressure situations. Possess the ability to interpret a variety of instructions furnished in written and oral forms. Complete routine clerical work such as filing, checking and entering required information into the computer system. Follow plant and laboratory GMPs to maintain a clean work area. Advise operations associates to assure GMPs are followed in the plant. Perform environmental and product testing and communicate results to the plant and corporate management groups as needed. Send timely "Out of Specification" (OOS) notices as needed to internal and appropriate corporate management QUALIFICATIONS: Previous laboratory experience, preferably in a food grade manufacturing facility Strong knowledge of laboratory testing procedures and computer software applications Exceptional analytical and organizational skills Strong interpersonal and communication skills Actus Nutrition is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic as defined by federal, state, or local laws.

Posted 1 week ago

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QA Product Manager
Catalent Pharma Solutions, Inc.Saint Petersburg, FL
QA Product Manager Position Summary St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems. This position is 100% on-site at the St. Petersburg site. The Role Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements. Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus. Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks. Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems Provide QA Technical recommendations based on trend analysis to eliminate future problems. Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines). Provide support to internal, client, and regulatory audits. Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times. All other duties as assigned. The Candidate Bachelor's Degree in Science (Chemistry, Microbiology or Biology preferred) required with a minimum of five years of related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries. Prior experience working with validation, manufacturing or product development preferred. Proven ability to multi-task and demonstrate diplomatic skills. Must possess excellent English verbal and written communication skills. Intermediate to proficient skills in Microsoft Office applications. Prior quality assurance experience is required. Working knowledge of cGMPs and/or OSHA regulations required. Certified Quality Engineer is a plus. Excellent oral and written communication skills a must. Proficient in Microsoft Word, Excel, Access and Power Point. Ability to speak effectively and present before groups within the organization. Ability to review and evaluate technical documents and determine impact to processes and systems in place. Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Why You Should Join Catalent Competitive medical benefits and 401K 152 hours of PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

Posted 30+ days ago

QA Technologist-logo
QA Technologist
King's HawaiianTorrance, CA
Joining King's Hawaiian makes you part of our ohana (family). We are a family-owned business for over seventy years, respecting our roots while thinking about our future as we continue to grow and care for our customers and the communities we serve. Our ohana members build an environment of inclusivity as they freely collaborate, pursue learning through curiosity, and explore innovation as critical thinkers. Beyond that, we are also passionate about supporting the long-term health and well-being of our employees and their families. If you're excited to rise with our team, come and join our `ohana! The Quality Assurance Technologist serves as senior QA technical resource and liaison between departments, who reports directly to the QA Supervisor and dotted line to the QA Manager. The critical technical functions of the position are to assist the QA Management to execute projects, develop, implement, maintain, provide training on and ensure effectiveness of site food safety and quality functions. The individual must have a quality conscious attitude with emphasis towards a teamwork approach to accomplish project goals and implement solutions to problems. The individual will work independently, be able to multitask, detail oriented, and have good decision-making skills based on the quality process from the beginning of manufacturing to the end. The individual will continually seek to improve oneself and provide technical information to other departments. PRINCIPAL ACCOUNTABILITIES Perform routine raw material and finished product QA/C functions as assigned by QA Management, which include but are not limited to the following: Process audit Laboratory QA/C testing and equipment calibration Product sensory evaluation Execute non-conformance product protocol (i.e., Hold) Assure compliance with food safety and quality standards throughout all operations and processes by conducting process/system audits, developing and implementing corrective actions. Assist SQF Practitioner to ensure SQF certification compliance by performing validation audit, updating and developing food safety protocols Collect, review, interprets, verify and analyze process QA/C data to identify process improvement opportunities. Participate in departmental and cross-functional continuous improvement projects as assigned by QA Manager. Assist QA Management to determine root causes for food safety and quality related issues, develop and implement corrective action plans. Assist QA Management to generate and to issue food safety and quality reports. Serve as senior technical resource for QA Technicians and other Operations personnel. Train new QA Technicians as required by QA Management. Perform other relevant duties assigned by QA Management. Actively participate to assure cross-functional issues are resolved and site concerns are addressed. Advises the QA and site Management of quality issues in a timely manner. Places on hold items that do not meet the specifications such as incoming material, work in process, and or finished goods. Presents reasons for retention and recommends possible solution to the issue. Inspects and calibrates equipment used in the lab. Report non-compliance findings and recommends next step solutions to QA and site Management on a timely manner. Monitors and enforces GLPs (Good Laboratory Practices), GMP (Good Manufacturing Practices) HACCP (Hazard Analysis Critical Control Points), and other employee safety, food safety and quality programs throughout the manufacturing facility. Informs, advises and updates company management of all quality related issues. Reviews, interprets, verifies, and summarizes data collected from other departments. Reports any deficiencies to QA Management in a timely manner. Responsible to generate relevant reports and conduct periodic internal site inspections. Assists QA Supervisor on various projects. Conducts SQF, GMP and other Food Safety and Quality trainings. Responsible for CCP verifications Responsible for Quality and Food Safety functions as assigned and outlined in Safe Quality Food (SQF) Program. Responsible for reporting all quality and food safety concerns/issues to QA. QUALIFICATIONS High school diploma or GED equivalent BS degree in Microbiology, Food Science, Biology or other related technical field. 2 - 3 years of QA/QC experience in food manufacturing or related fields Strong working knowledge of common food QA/C laboratory methods. Strong working knowledge HACCP and pre-requisite programs. Demonstrated working knowledge of current SQF Food Safety Program, BRC certification, or other GFSI certification requirements. Hands-on GMP / Food Safety / Quality System audit experience. Familiar with current food regulatory requirements and standards such as those of cGMP Demonstrates problem solving skills. Able to effectively communicate verbally as well as in writing; demonstrate ability to write effective technical procedures and reports; bilingual in English / Spanish is preferred. Able to take on projects with minimum supervision, complete tasks in a proficient manner, and work as a team Demonstrates ability to work effectively in team based and fast paced environment. Demonstrates effective project management and/or execution skills. Demonstrates intermediate to advanced computer skills: MS Excel / Word / Outlook. Able and willing to work flexible schedule. Desired Personal Traits Team player with good communication, collaboration, and interpersonal skills. Highly motivated, takes initiative, and able to lead and follow. Critical and independent thinker. Flexible, adaptable, and willing to handle an ever-changing work environment. Have a "can-do" attitude and be open to constructive feedback and coaching Committed to continuous improvement of self and team Strong organizational skills; results oriented; tenacious; creative. Note: This position description indicates the critical features of the role as they are presently envisioned. They are subject to change at any time due to business conditions or other reasons. The incumbent may be asked to perform other duties as required. Compensation Range: $24.00-$36.00 per hour King's Hawaiian is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for our ohana.

Posted 30+ days ago

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Joint Use Design Qa/Qc - Remote Work
Orbital Engineering, Inc.Pittsburgh, PA
Joint Use Design QA/QC Working with our business partners to create, improve and sustain industry and infrastructure. Orbital Engineering has been driven by this core purpose for more than 50 years - energizing Orbital team members and helping our clients solve challenging and complex problems with innovative engineering, inspection, and construction solutions. Orbital team members are guided by the fundamental beliefs of building trusted relationships, personal accountability, innovation, and excellence in everything we do. Orbital is looking for others to join our team to continue activating our purpose and embrace our values. Orbital Engineering's Utility Infrastructure Improvement (UII) Department partners with Utility and Communication Companies in Engineering and Construction operations for Joint Use Pole Attachment Programs (JU), Distribution Engineering Design Projects, and Distribution System Improvement Charge (DSIC) programs, such as the Pennsylvania Long-Term Infrastructure Improvement Program (LTIIP). This Joint Use Design QA/QC position will directly support projects within the UII Department's pole attachment application process and power delivery improvement process. The team is also responsible for analyzing requests for attachment to client's poles and network reliability improvements on client's electric distribution systems. The staff also support GIS data analytics, creation of notifications, work orders, invoicing, and financial reports utilizing enterprise resource planning software. Orbital Engineering, Inc. is currently seeking a Joint Use Designer to serve in a QA/QC role and be based in a REMOTE WORK position. Responsibilities include but are not limited to: Ensure Orbital's QA/QC process is followed in order to validate all project deliverables prior to submission to the client. Conduct a thorough review of design packages to ensure compliance with NESC, Orbital and client standards. Provide timely feedback and technical guidance to less experienced team members in order to improve overall design quality and increase efficiency. Visually identify, inspect, and record equipment and different construction situations in the field, including rights-of-way Apply National Electric Safety Code (NESC) Standards, Client Standards, Federal, State or Local Municipal Guidelines, and/or other applicable guidelines to complete engineering designs (Pole Replacements, Communication Space Rearrangements, Joint-Use Design) for possible joint-use or make-ready construction Ability to analyze field collected data (including imagery) and accurately update applicable software packages for successful design implementation Regularly utilizes Client proprietary software packages or equipment to complete daily responsibilities in the engineering design workflow process, may include facilitating new attachment permitting process Communicate with others, including co-workers and clients, to agree on the best solution for engineering design Accountable for work assigned and responsible for completing work on project schedule and within project budget while regularly communicating status with management team Frequently communicates with Client(s) on engineering design to best determine the most cost-effective solution for their project Provides timely and detailed documentation and support to Orbital accounting functions for ensuring projects are on budget and appropriately accounted Can transcribe notes, use measuring devices to identify, inspect, and record the data which is found in an organized manner Can endure frequent driving, standing, walking (numerous miles a day), navigating (on foot or in a vehicle), and balancing objects which may weigh up to 20 pounds in congested and/or complex terrain As needed, must be able to work in all weather conditions and in residential, commercial, and industrial areas Work is primarily office based but fieldwork may be needed throughout the engineering design process Must be willing to travel overnight or for extended periods of time, based on project assignment Will be required to attend meetings at clients' sites and regularly interact with the general public, including landowners and operators May occasionally enter energized extra-high voltage substations up to 745kV and will need to coordinate with appropriate utility personnel throughout fielding activities within this location Minimum Requirements Demonstrated experience serving in a QA/QC role in a Joint Use / Make Ready design environment. Proficiency with NESC requirements Ability to interpret client design standards and readily apply them to design deliverables. Ability to convey, verbally and electronically, constructive feedback to junior team members in order to remedy design deficiencies. High School Diploma or GED required with 3+ years of experience in fieldwork or a construction environment, drafting, utility experience, or technical design Associates Degree in Engineering, Engineering Technology, or related technical discipline with 0-2 years of experience, with interest in fieldwork, or surveying Must be an organized person who can keep data organized from start to finish on a project Ability to prioritize work on multiple projects and effectively communicate project statuses Computer proficiency including general Microsoft Office products, design, and business enterprise software Effective written and oral communication at all levels within an organizational structure Reasoning skills and ability to solve practical problems Must have dependable transportation and a valid driver's license with insurance Must be able to pass a fit for duty test Ability to work from home and an office setting, as required This position requires the ability to pass a post-offer drug (including marijuana) and alcohol test in compliance with Federal regulations and is also subject to random testing as a condition of continued employment. Preferred Qualifications Ability to read and understand engineering drawings/schematics Working knowledge of electrical distribution assets and/or communication equipment construction Experience in pole loading (Spida Calc, O-Calc, Pole Foreman, or Katapult) or other construction modeling software (AutoCAD) is beneficial Knowledge of industry utility or joint-use software (SPANS, NJUNS, IkeGPS) for make-ready engineering and construction is beneficial Familiar with Design and Checking practices for engineering drawings and deliverables Familiar with Safe Work Practices and PPE applications Preferred previous experience completing Joint-Use Make Ready designs Orbital Engineering, Inc. has provided worldwide professional engineering and consulting services since 1969. Our commitment to quality, responsiveness, and attention to detail has earned us the reputation as a leading provider of engineering and design services. A commitment to excellence and hard work will be rewarded with a competitive salary, career advancement opportunities, and an excellent benefits package including medical, dental, vision, prescription drug, 401(k), and supplemental insurance. Orbital Engineering, Inc. is an Equal Opportunity Employer, EEO/AA/M-F-V-D. Orbital Engineering, Inc. seeks diversity among its employees. Reasonable accommodations may be made to enable individuals to perform the essential job functions. JOI00002083 #LI-CV1

Posted 2 weeks ago

QA Specialist 2-logo
QA Specialist 2
ProKidneyWinston Salem, NC
Position Summary: This on-site Quality Assurance On the Floor (OTF) Specialist 2 reports directly to the Manager, QA Floor Support. This position will be based at our cGMP Manufacturing site and will directly support the CMC clinical manufacturing program. The main responsibility for this position is to provide real-time on the floor quality oversight of all Manufacturing activities, with a focus on adherence to aseptic technique, GMP principles during processing, batch record review, and deviations. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, Validation, Supply Chain and Facility teams. Responsibilities: Provide quality on-the-floor support of manufacturing processes, reviewing batch record documentation, and providing real-time support of manufacturing, issues, changeovers etc. Participate in quality oversight of manufacturing through real-time observations of activities. Provide guidance on GMP principles and aseptic technique during routine operations. Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data. Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise. Perform review of Environmental Monitoring results associated with GMP operations. Support quality decisions that may impact operations, ensuring appropriate escalation. Identify risks and communicate gaps for quality and GMP process/systems. Review and approve facility alarms, facility work order requests, inventory requests, batch record requests, and return-to-service documentation. Supports, reviews and approves Deviations and Change Controls Identify risks and communicate gaps for quality and GMP process/systems. Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed. Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor and major manufacturing deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Ability to manage multiple assignments and/or projects in a fast-paced environment. Collaborate and lead effectively in a dynamic, cross-functional matrix environment Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations. Participate in quality focused teams across ProKidney's broad ecosystem of functions. Support internal audits. Collaborate with Manufacturing and Quality Operations to ensure appropriate and rapid disposition of clinical products. Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review. Utilize knowledge to improve operational efficiency. Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems. All other duties as assigned. Qualifications: Bachelor's degree in applied science. 2+ years' relevant experience with working in Quality Assurance, ideally within cGMP aseptic manufacturing operations. Preferred experience in cell or gene therapy. Weekend work may be required based on business needs Strong organizational, analytical, and time management skills. Ability to work well in a team environment with a positive attitude that is willing to assist other areas of the organization. Excellent verbal and written communication skills as well as strong focus and attention to detail. Demonstrate ability to handle multiple tasks at one time and maintain a strong attention to detail. Ability to perform frequent physical tasks with strength and mobility. Flexible scheduling required. Any equivalency combination of education, experience, and training may substitute. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship. Create a Job Alert Interested in building your career at ProKidney? Get future opportunities sent straight to your email. Create alert

Posted 30+ days ago

Construction QA, QC And Electrical Commissioning Engineer-logo
Construction QA, QC And Electrical Commissioning Engineer
JLLBaltimore, MD
JLL empowers you to shape a brighter way. Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong. Whether you've got deep experience in commercial real estate, skilled trades or technology, or you're looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward. Construction QA, QC and Electrical Commissioning Engineer: JLL is currently seeking a dynamic individual for the role of Construction QA/QC and Electrical Commissioning (Cx) Engineer to provide reliable, timely, efficient support to our Data Center / Mission Critical team. This position entails working with a diverse group of internal and external stakeholders at all levels of the project organization, and requires independent judgement to plan, prioritize, and organize a diverse workload in a fast-paced environment. The successful candidate will be detail oriented with strong organizational skills, and possess a team player attitude. In particular, you will be responsible for carrying out the following duties specific to your position: Have fluency and experience with the commissioning processes and deliverables covered in ASHRAEcommissioning guidelines. Expertise in electrical equipment/systems installation (means & methods), equipment and system startup and pre-functional inspections, acceptance testing and associated commissioning activities. General working knowledge and experience in Mechanical and Plumbing equipment/systems installation (means & methods), system startup and pre-functional testing, inspections, acceptance testing and associated commissioning activities. Work directly with General Contractors, sub-contractors, inspectors, AHJs, and others involved with the QA/QC and Commissioning program execution for critical facility construction and commissioning. The candidate will be expected to demonstrate strong management and technical functions throughout the design, pre-construction, construction, and post-construction phases of projects. The candidate will protect JLL's contractual position and ensure our work meets contracted requirements. Develop Commissioning Plans and Commissioning Specifications. Implement and execute electrical and EPMS QA/QC inspection programs for large, complex critical facility construction and commissioning projects including developing inspection and commissioning checklists, test scripts and procedures, and other required documentation required by the Owner's and/or General Contractor's QA/QC program. Carry out field-based commissioning activities, including: Site visits Develop Start-up and test forms; witness and approve contractor execution Develop Functional Test scripts; manage, direct and witness execution Develop Integrated Systems Test scripts, direct and witness execution Perform Commissioning Design Drawing, Specifications, and Submittal Reviews. Schedule, lead and document project Commissioning meetings. Understanding of how to develop and execute seasonal/performance tests. Ability to write detailed standard operating procedures (SOPs) and Methods-of-Procedures (MOPs). Ability to develop and compile project documentation into site/project specific Systems Manuals. Proficiency in use of QA/QC and Cx software applications such as BIM360, CxAlloy, Facility Grid, and other related QA/QC and Cx applications. Ability to develop/review/evaluate vendor training programs for installed equipment and systems. The candidate will support, front to back, all of the project documentation requirements, accountable for the preparation, review, and issuance of same, and though these tasks may be delegated, there may/will be the need to personally prepare them to meet the required timelines. The candidate will perform, front to back, all the field activity components. This includes scheduling and coordinating JLL and project team members accordingly, ensuring our requirements are fulfilled by the contractor and relevant sub-trades, and maximizing efficiency/productivity of our staff. Willingness to travel up to 50% to client sites across the USA Qualifications A minimum of 10 years of relevant electrical engineering and/or field-testing experience with minimum of 5 years in providing building commissioning and/or construction QA/QC and Commissioning field services An engineering or technical degree from an ABET accredited program is preferred. Possess a Commissioning Professional certification from a recognized industry authority Prof Eng/PE or PMP designation is considered a strong asset for this role, but not required. Ability to use electrical testing meters and equipment and analyze and report on test results including Power Quality Meters (PQM), thermography, NETA tests, ground tests, hi-pot, megger, etc. Knowledge and experience in testing Utility transformers, UPS systems, generators and associated automated paralleling switchgear, ATSs and STSs, Fuel Oil systems, PDUs, EPMS, and other electrical power generation and distribution systems Strong data management skills Excellent written and verbal communication skills Proficiency in MS Project, Word, and Excel Demonstrated ability to coordinate and organize multiple project schedule inputs/performance data into a master schedule platform and deliver project/program status reports as required. Demonstrated ability to analyze and report against contractor (and other third party) schedule updates Experience working in a consultancy or owner organization is an asset Estimated total compensation for this position: 120,000.00 - 140,000.00 USD per year The total compensation range is an estimate and not guaranteed. An employment offer is based on an applicant's education, experience, skills, abilities, geographic location, internal equity and alignment with market data . Location: On-site -Atlanta, GA, Baltimore, MD, Boston, MA, Dallas, TX, Houston, TX, Los Angeles, CA, New York, NY, Olympia, WA, Raleigh, NC, Richmond, VA, San Diego, CA If this job description resonates with you, we encourage you to apply, even if you don't meet all the requirements. We're interested in getting to know you and what you bring to the table! Personalized benefits that support personal well-being and growth: JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include: 401(k) plan with matching company contributions Comprehensive Medical, Dental & Vision Care Paid parental leave at 100% of salary Paid Time Off and Company Holidays JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL's recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. For more information about how JLL processes your personal data, please view our Candidate Privacy Statement. For additional details please see our career site pages for each country. For candidates in the United States, please see a full copy of our Equal Employment Opportunity policy here. Jones Lang LaSalle ("JLL") is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process - including the online application and/or overall selection process - you may email us at accomodationrequest@am.jll.com. This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page > I want to work for JLL. Pursuant to the Arizona Civil Rights Act, criminal convictions are not an absolute bar to employment. Pursuant to Illinois Law, applicants are not obligated to disclose sealed or expunged records of conviction or arrest. Pursuant to Columbia, SC ordinance, this position is subject to a background check for any convictions directly related to its duties and responsibilities. Only job-related convictions will be considered and will not automatically disqualify the candidate. California Residents only If you are a California resident as defined in the California Consumer Privacy Act (CCPA) please view our Supplemental Privacy Statement which describes your rights and disclosures about your personal information. If you are viewing this on a mobile device you may want to view the CCPA version on a larger device. Pursuant to the Los Angeles Fair Chance Initiative for Hiring Ordinance, JLL will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Accepting applications on an ongoing basis until candidate identified.

Posted 2 weeks ago

QA Tech - 2Nd Shift-logo
QA Tech - 2Nd Shift
Smithfield Foods, Inc.Orange City, IA
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! Our Opportunity Supports needs of Quality Assurance department while interfacing with production and receiving/shipping departments to ensure that products are safe, wholesome and meet quality standards. Hourly Competitive Starting Pay - $21.70/hour $1.00/hour shift differential for 2nd shift positions Comprehensive Health Insurance, Retirement Benefits and More. Core Responsibilities Collect and file production paperwork for QA department auditing purposes Sample finished products to assure compliance with customer specifications Sample inbound raw materials in a statistically significant manner. Conduct metal detector verification checks on production lines Calibration of thermometers Record temperatures of outbound loads Gather composite samples when necessary Prepare samples for shipments to customers Manage sample submission to outside labs Cross train w/ lab personnel to perform lab testing duties when required Performs self-quality audits within the plant Supports IMS/Scan4Ship labeling/hold/lot/BOL standards and processes Other projects as needed by area supervisor and/or manager. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. High School diploma or GED preferred. 1+ years of quality and/or lab experience in the food industry is preferred. Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English. Work Environment & Physical Demands The work environment characteristics & physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Noise level in the work environment is usually moderate but can be loud when in the production area. Specific vision abilities required include close vision, distance vision and ability to adjust focus. Frequently required to stand; walk; use hands to handle or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. Exposure to wet conditions The employee is regularly required to use hands to handle, grasp with both hands, or feel; substantial movements (motion) of the wrists, hands, and/or fingers; reaching and pulling with hands and arms. Prolonged standing or sitting - Occasional walking is required for short distances. Ability to consistently move/drag/lift up to 60 lbs frozen raw materials on a regular basis. Ability to consistently move/drag 100-150 plastic totes. Frequent stretching out of arms and use of upper body. Occasional turning and twisting at the waist. Relocation Package Available No EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 1 week ago

QA Technician - 3Rd Shift - Fabrication-logo
QA Technician - 3Rd Shift - Fabrication
Sub-Zero and WolfMadison, WI
Sub-Zero, Wolf, and Cove the leading manufacturer of luxury kitchen appliances is a longstanding, family-owned company in the Madison area. Icons of design and paragons of performance and quality, Sub-Zero, Wolf, and Cove are the refrigeration, cooking, and dishwashing specialists found in world's most luxurious homes. We look for team members who are driven by innovation and excellence, striving to serve our customers by doing what is right-with integrity, teamwork, and accountability. Overview Sub-Zero, Wolf, and Cove the leading manufacturer of luxury kitchen appliances is a longstanding, family-owned company in the Madison area. Icons of design and paragons of performance and quality, Sub-Zero, Wolf, and Cove are the refrigeration, cooking, and dishwashing specialists found in world's most luxurious homes. We look for team members who are driven by innovation and excellence, striving to serve our customers by doing what is right-with integrity, teamwork, and accountability. This position will ensure product quality and customer satisfaction. Performs quality checks, process audits, and aesthetic/dimensional reviews on fabricated components and assists in data analysis on Fabrication processes. Leads continuous product and process improvements and performs root cause analysis and executes problem solving actions. Growth and development are important aspects of this position. Whether you aspire to be a leader or a technical expert, this position will set you up for success in the future. Primary Responsibilities Performs detailed inspections, audits, and testing of parts and products to ensure they meet dimensional, functional, and aesthetic requirements. Communicates nonconforming product quality issues to the appropriate individuals and departments. Implements procedures and systems necessary to promote continuous improvement of parts and products. Assist in troubleshooting and analyzing nonconforming product to determine root cause and drive permanent corrective action. Generates reports and communicates information using various Microsoft Office software applications. Analyzes data as needed to assist in production of complex fabricated assemblies. Required Qualifications: High School Diploma or equivalent. The ability to work in a team environment and to handle stressful situations with professionalism. Excellent verbal and written communication skills. Experience with Microsoft Office Applications (Word, Excel, Outlook, and PowerPoint). Experience with Calipers, Protractors, Aesthetic/Cosmetic Requirements. Ability to read and interpret blueprints. Experience in quality assurance and/or extended on-the-job work experience in a manufacturing environment. Preferred Qualifications: Experience with basic quality problem solving tools (Histograms, Pareto, Run charts, Cause-Effect diagrams, etc.). Experience with Surface Plate, Height Gauges, Micrometers, CMM's and Aesthetic/ Cosmetic Requirements. Experience with the manufacturing of fabricated sheet metal parts is preferred. Experience with control plans and other inspection documentation. We value our employees by providing: Competitive compensation based on skills Industry leading health, dental, and vision plans Generous 401 (K) savings and profit sharing On-site UW Health clinic, fitness center, and walking paths Education assistance and internal training programs Electric vehicle charging Maternity & paternity leave Interested in learning more on our robust benefits package we offer? Click here! This position requires a pre-employment drug/alcohol test and background check, which will be administered after a conditional job offer is extended. A negative drug/alcohol test result is required for employment. Refusal to take the test or a positive result may disqualify a candidate from further consideration. All drug testing will be conducted in accordance with federal and state laws.

Posted 30+ days ago

QA Technician-logo
QA Technician
U-HaulTempe, AZ
Return to Job Search QA Technician Job Description Perform dimensional, mechanical and visual inspections to determine the acceptability of parts in the First Article process. Perform product test evaluations on production parts and assemblies to determine their condition against approved drawings, established standards, and fit for intended use applications. Must be capable of interpreting drawings and blueprints to accomplish a specific task. Must have exceptional written and oral communication skills and be able to interact with a variety of people. Computer skills (intermediate knowledge of MS Office programs such as Word, Excel) are required. Duties Perform dimensional and visual inspection requirements utilizing drawings, OEM manuals, and/or written instructions Record and document findings legibly and precisely Interpret and analyze test requests to prepare test procedures for testing. Perform product evaluation testing on parts and sub-assemblies for monthly/yearly verification/certification. Record and analyze requested test data from test results. Utilize test equipment to produce, regulate, and record effects/results of actual or simulated conditions such as stress, vibration, pressure, accelerations, salt exposure, humidity, temperature, QUV, material hardness, abrasion, etc. for QC testing/inspection. Measure physical properties of test specimens following a prescribed series of operations on various types of test machines. Reasonable and predictable attendance is required Complete work to meet test/inspection schedules, work OT as needed. Experience Must be able to read, comprehend, and interpret dimensional drawings, technical documents, and manuals, ensuring that products and parts meet quality standards. Proficient use of calipers, gauges, micrometers, dial indicators, optical comparator, multi meter, and other mechanical, electrical, and electronic test gear for performing fine measurements and test functions. Write test outlines and test reports on inspection and test data. Knowledge of basic math and computer skills for measuring, calibrating, and calculating specifications for quality control testing. Must be able to use specialized tools (hand & power) and operate sophisticated electronic instrumentation for in-house lab tests. Must be proficient in Microsoft Excel and Word. 3+ Years' experience performing as an accomplished QC inspector or equivalent. Education High school degree with post secondary vocational program desired. May be substituted with experience U-Haul is an equal opportunity employer. All applications for employment will be considered without regard to race, color, religion, sex, national origin, physical or mental disability, veteran status, or any other basis protected by applicable federal, provincial, state, or local law. Individual accommodations are available on requests for applicants taking part in all aspects of the selection process. Information obtained during this process will only be shared on a need to know basis.

Posted 2 weeks ago

Engineer II QA - Manufacturing-logo
Engineer II QA - Manufacturing
Arthrex, Inc.Ave Maria, FL
Requisition ID: 63269 Title: Engineer II QA - Manufacturing Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II - QA for our manufacturing site in Ave Maria, FL. The ideal candidate will have a Bachelor's degree in Engineering and 2+ years experience in a Quality Control or Quality Assurance position in a Medical Device Company. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Essential Duties and Responsibilities: Review design drawings for tolerance, inspect-ability and quality of design issues. Work with suppliers to improve quality, and assist, where necessary, in supplier process validations. Assist in the training of QC Inspectors on inspection techniques and the use of new equipment. Participate in Internal and External quality audits as directed by the Quality Assurance Manager. Support Risk Management by leading or participating in cross-functional team pFMEA's and Risk Assessments. Support the AMI Engineering Change Management process by performing tasks as assigned. Lead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier). Lead or Support equipment or process validation (IQ, OQ, PQ) Lead or support Metrology with design and development of inspection methods and gages. Create or review inspection method work instructions. Lead or support Metrology with Measurement System Analysis (Gage R&R) studies. Create Inspection Plans Supporting Receiving and In-Process Inspection. Investigate complaints as requested by the Complaints/Reliability team. Lead completion of Nonconformances (NCR's) as assigned: material disposition plans, evaluations, and action plans. Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team. Lead or Support Continuous Improvement projects. Lead or support the Environmental Monitoring program. Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA's). Perform Engineering Studies and Design of Experiments (DOE) as needed. Education and Experience: Bachelor's degree in Engineering required. 2 years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred. Knowledge and Skill Requirements/Specialized Courses and/or Training: Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation. SPC (Statistical Process Control) knowledge. Working knowledge of process improvement tools (i.e.: Lean- PDCA, Six Sigma- DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys) preferred. Working knowledge of risk assessments, PFMEAs, control plans, quality plans. Strong communication skills and ability to communicate effectively with technical and non-technical staff. Project management skills preferred. Machine, Tools, and/or Equipment Skills: Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab or similar statistical analysis software, SAP or similar inventory software, Agile or similar design lifecycle software, Pilgrim or similar QMS software. Knowledge of measurement and other inspection equipment. Manufacturing process knowledge Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Mathematical Skills: Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Prefer working knowledge and application of Statistics. Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Vision Requirements: Visual acuity necessary to do the job safely and effectively. Specific vision abilities required by this job include close vision using a microscope and light source. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free Onsite Medical Clinics Free Onsite Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Jul 3, 2025 Requisition ID: 63269 Salary Range: Job title: Engineer II QA - Manufacturing Arthrex Location: Ave Maria, FL, US, 34142 Nearest Major Market: Naples Job Segment: Medical Device Engineer, QA, Quality Assurance, Lean Six Sigma, QC, Engineering, Quality, Technology, Management

Posted 4 weeks ago

I
Incog Biopharma Services Careers - QA Associate, 3Rd Shift
INCOG BioPharmaFishers, IN
Working closely with the QA Operations Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Support other QA personnel with batch record reviews, material release, etc. Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing. Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

Quality Assurance Supervisor/Sr. Supervisor - QA Analytical-logo
Quality Assurance Supervisor/Sr. Supervisor - QA Analytical
KBI BiopharmaDurham, NC
Job Summary: This position is primarily responsible for supervising a staff that supports the coordination, tracking and review of Test Sample Plans (TSPs) and the associated in-process data associated with batches manufactured at KBI. This position is also responsible for the review and approval of release and stability test data as needed. Experience in the review and approval of laboratory investigations and deviations is also beneficial to this position Responsibility: 1) Responsible for the coordination and tracking of test sample plans(TSPs) and associated in process data. Report out metrics to relevant operational meetings and/or client meetings. (15%) 2) Perform compliance review of test sample plans and associated in-process data. (55%) 3) Supervises direct reports providing coaching and mentoring. (5%) 4) Develop and/or support training materials for QA review of Test Sample Plans. (5%) 5) Work with functional areas to improve the lifecycle of Test Sample Plan review cycle times and batch release dates. (5%) 6) Responsible for the review of release and stability data as needed. (5%) 7) Responsible for the review and approval of laboratory investigations, deviations, and CAPAs. (5%) 8) Attend relevant operational meetings in support of disposition activities. Support Client Audits and Regulatory Inspections as required. (5%) Minimum Requirements: 1) Knowledge, Skills, Abilities: BS in scientific field with 15+ years' experience or MS and 10+ years' experience in a QA cGMP regulated environment within biopharmaceuticals or equivalent. Experience with quality systems to include batch release review, batch disposition of biopharmaceuticals, and lab investigations and deviations. Knowledge of US and EU guidelines is a plus. 2) Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients and customers. 3) Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 4) Math Ability Basic math skills are required. Ability to apply concepts of basic algebra and statistics. 5) Physical Demands Sitting at a computer for long periods of time. 6) Computer Skills Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management 7) Equipment Use Computer and telephone KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 2 weeks 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 30+ days ago

Grow Therapy logo
QA Engineer II
Grow TherapyNew York City, NY

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Job Description

About the Role:

Our engineering teams are looking for a QA Engineer with a strong background in the software development life cycle. You'll help Grow Therapy providers and clients with the data, tools, and support they need to establish deep connections with each other, to unlock lifelong mental health support, and drive positive mental health outcomes. This is an exciting opportunity for a passionate, mission-aligned QA engineer to make an immediate impact on our rapidly scaling team.

What You'll Be Doing:

  • Maintain and improve the quality and reliability of the application through daily smoke testing and exploratory testing
  • Collaborate with cross-functional stakeholders to build out and run test plans for large feature launches
  • Identify improvements in company QA processes to improve overall software development life cycle
  • Own end to end defect tracking and resolution processes
  • Serve as the subject matter expert on team's surface area and how it interacts with other team surface areas

You'll Be a Good Fit If You Have:

  • 3+ years of proven QA experience, ideally in a high-growth, fast-paced environment.
  • You pride yourself on your attention to detail and easily can put yourself in user shoes to ensure we are providing a best in class experience our users deserve.
  • You have a strong bias for action and can drive value with little to no guidance.
  • You enjoy communicating effectively and building relationships with both technical and non-technical stakeholders.
  • You welcome ambiguity and leverage structured thinking to solve problems.

Nice to Have's:

  • Prior experience working across multiple engineering teams.
  • QA automation experience.
  • Experience testing AI-driven features or using modern AI tools to boost your productivity.
  • Exposure to health-tech data / EHR integrations.

If you don't meet every single requirement, but are still interested in the job, please apply. Nobody checks every box, and Grow believes the perfect candidate is more than just a resume.

Salary range: $120,000-$140,000

Please Note: This role is based out of the New York City metropolitan area, the San Francisco Bay Area, or the Greater Seattle area.

We use Covey as part of our hiring and / or promotional process for jobs in NYC and certain features may qualify it as an AEDT. As part of the evaluation process we provide Covey with job requirements and candidate submitted applications. We began using Covey Scout for Inbound on January 11, 2025.

Please see the independent bias audit report covering our use of Covey here.

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