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Catalent Pharma Solutions, Inc.Harmans, MD

Job Description Specialist, QA OTF (PM Shift) Summary: Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA On-The-Floor (OTF) oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. This is a full-time on-site position, 7pm-7am 2-2-3 rotation 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 Role: Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product- 75% of day is spent on the floor. Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing. Partner with Manufacturing and other support teams Perform Acceptable Quality Limit (AQL) visual inspection of drug product Review and approve batch documents for media and buffer prep solutions Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's Compile deviations as required when observed on the floor, and move to completion within the required time frame Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product- 75% of day is spent on the floor. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Make solid quality decisions with limited oversight Identify and implement and continuous improvement initiatives Participate in site and corporate quality and process improvement initiatives. Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices. Actively participates in training activities, managing their individual training plan. Other duties as assigned. The Candidate: Masters' degree in a Scientific, Engineering or Biotech field with 0 - 2 years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. OR Bachelor's degree in a Scientific, Engineering or Biotech field with 2 - 4 years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. Strong understanding of GMPs (21 CFR Parts 210, 211, 600s), ICH, and EU GMPs. Familiarity with biological manufacturing processes (microbial/cell culture, fermentation, purification, fill/finish). Knowledgeable in applying scientific and regulatory principles to solve operational and quality tasks. Familiar with electronic systems (Microsoft products; LIMS, Master Control, Trackwise preferred) and possesses strong analytical, troubleshooting, and decision-making skills. Adaptable and proactive, capable of learning new processes quickly, working independently and collaboratively to meet deadlines in a fast-paced environment. The anticipated salary range for this position in Maryland is $74,080 -$101,860 plus shift differential and annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Position Benefits: Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement 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 4 weeks ago

Software QA Analyst III

CACI International Inc.Norfolk, VA

Software QA Analyst III Job Category: Engineering Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: Up to 10% Type of Travel: Continental US The Opportunity: Join CACI as the prime contractor on a growing program supporting NAVSEA 03D3 Digital Program Office as a Software QA Analyst supporting the Navy Maintenance and Modernization Enterprise Solution (NMMES), a mission-critical program that supports over 45,000 users executing naval ship and submarine maintenance operations worldwide. Key Responsibilities: Provide test and evaluation of ongoing research and development projects Develop and document comprehensive test plans and procedures Conduct complex testing across multiple platforms and applications Evaluate and document test results with detailed analysis Prepare in-depth studies, plans, and analyses in support of delivery orders Lead testing efforts for both legacy and modern applications Implement and execute automated testing strategies Validate system requirements through comprehensive testing Identify and document software defects and issues Track and verify bug fixes and system enhancements Collaborate with development teams on quality improvements Mentor junior QA team members Contribute to the development of QA standards and processes Qualifications: Required: Bachelor's Degree in Computer Science, Information Systems, or related field More than 5 years of experience in software quality assurance Strong knowledge of software testing methodologies Experience with test automation tools and frameworks Demonstrated analytical and problem-solving abilities Desired: Experience with DoD/Navy programs Software testing certifications (ISTQB, etc.) Knowledge of Agile testing practices SAFe certification Experience with performance testing Security testing knowledge Familiarity with test management tools Experience testing legacy systems Additional Information: This position offers an opportunity to ensure the quality of critical Navy maintenance systems. The ideal candidate will combine strong testing expertise with analytical skills and attention to detail. Success in this role requires: Comprehensive understanding of QA methodologies Strong analytical abilities Excellent documentation skills Problem-solving capabilities Team collaboration abilities Technical aptitude Note: Position supports NMMES software suite which includes both legacy software applications and current web application technologies running on multiple operating systems. Key Success Factors: Experience with complex system testing Strong technical documentation abilities Test automation expertise Requirements analysis skills Process improvement capabilities Mentoring abilities The role requires someone who can: Develop comprehensive test plans Execute complex test scenarios Document detailed test results Identify and track defects Collaborate with development teams Improve testing processes Guide junior team members Special Requirements: Must be able to obtain and maintain required security clearances Must understand DoD testing requirements Must be able to work in classified environments when required Must be detail-oriented and thorough in testing Must maintain technical currency Quality Focus Areas: Functional testing Performance testing Security testing Integration testing User acceptance testing Regression testing Automated testing This role represents an opportunity to ensure the quality of mission-critical Navy systems while working with both legacy and modern technologies. The position offers the chance to shape quality assurance practices while working in a complex, dynamic environment. Professional Development: Exposure to diverse testing technologies Opportunity to develop automation frameworks Experience with complex system testing Development ____ What You Can Expect: A culture of integrity. At CACI, we place character and innovation at the center of everything we do. As a valued team member, you'll be part of a high-performing group dedicated to our customer's missions and driven by a higher purpose - to ensure the safety of our nation. An environment of trust. CACI values the unique contributions that every employee brings to our company and our customers - every day. You'll have the autonomy to take the time you need through a unique flexible time off benefit and have access to robust learning resources to make your ambitions a reality. A focus on continuous growth. Together, we will advance our nation's most critical missions, build on our lengthy track record of business success, and find opportunities to break new ground - in your career and in our legacy. Your potential is limitless. So is ours. Learn more about CACI here. ____ Pay Range: There are a host of factors that can influence final salary including, but not limited to, geographic location, Federal Government contract labor categories and contract wage rates, relevant prior work experience, specific skills and competencies, education, and certifications. Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives. We offer competitive compensation, benefits and learning and development opportunities. Our broad and competitive mix of benefits options is designed to support and protect employees and their families. At CACI, you will receive comprehensive benefits such as; healthcare, wellness, financial, retirement, family support, continuing education, and time off benefits. Learn more here. The proposed salary range for this position is: $75,200-$158,100 CACI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, age, national origin, disability, status as a protected veteran, or any other protected characteristic.

Posted 1 week ago

Group Leader - QA Technician

Silgan Containers CorporationSlatersville, RI

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

Posted 30+ days ago

QA Automation Intern

GN GroupDover, NH

QA Automation Student/Intern Consider before applying: This position is expected to start around early August 2025 and continue through Dec 2025. Internships are in-person for 20 hours a week for a minimum of 24 weeks. Location: This is a hybrid position requiring 50% onsite presence at either the Dover, NH location or our Lowell, MA office. Summary: Your role as a QA Automation Engineer is to write scripts and create automation environments for repeated tests. Using different automation tools, you will design, test, and deploy effective test automation solutions. Your goal is to automate as much of the testing effort focusing on repeatability and accuracy. Responsibilities: Write, design, and execute automated tests by creating scripts that run testing various headset functionalities automatically Maximize test coverage for the most critical features of the system Determine the priority for test scenarios and create execution plans to implement these scenarios Write documentation for automated processes including test plans, test procedures, and test cases Log and document bugs in the tracking system (JIRA) Skills Required: Technical Skills: Programming skills to write computer code and scripts in common computer languages, such as Java/Kotlin (Android), Python, C/C++. Analytical skills: Analytically examine bug reports, prioritize necessary tests, and streamline application functions through automated testing processes. Attention to detail: Being detail oriented is required as you will test native (C/C++), Cloud and mobile applications to find ways to improve them and isolate problems. Communication skills: Strong verbal communication skills to effectively collaborate with the engineering team and create testing plans and written test reports. Tools: Automation testing tools: Selenium, Appium, PyUnit Mobile automation testing tools for Android, iOS, and cross-platform Eval boards: RaspberryPi Continuous Integration tools: Github, Azure Pipelines, Jenkins Wireless communication tools: Bluetooth sniffer, Wireshark JIRA: Defect tracking and task creation tool Confluence: Documentation, requirements, and test reports Qualifications and Certifications: Computer Science / Electrical engineering background (required) 1-2 years QA Automation / SW development experience (preferred) Experience in audio consumer electronics products (preferred) Experience with Agile methodology (preferred) Pay Transparency Notice: The hourly wage for this position can range from $25.00 to $40.00. Compensation for roles at GN depend on a wide array of factors including but not limited to location, role, skill set, education, and level of experience. Equal Opportunity Employer: GN Audio makes life sound better by developing intelligent sound solutions that transform lives through the power of sound, enabling you to hear more, do more & be more than you ever thought possible. Our integrated headset and communications solutions assist professionals in all types of businesses in being more productive. Our wireless headsets and earbuds are designed to fit any lifestyle - from sports enthusiasts to commuters and office workers. GN group operates in more than 90 countries across the world. Founded in 1869, GN group today has more than 6,000 employees. GN Hearing Care Corp. is an EEO Employer and does not discriminate in employment on the basis of race, color, religion, gender, national origin or ancestry, age, disability, veteran status, military service, sexual orientation, genetic information, or gender identity. View The EEO is the Law poster and its supplement. View the Pay Transparency Nondiscrimination Provision E-Verify: GN participates in E-Verify. View the E-Verify poster here. View the Right to Work poster here. Disability Accommodation: If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail careers.us@gn.com or call 978-606-2210. This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. #LI-Jabra

Posted 1 day ago

IT QA Technical Lead

Leslie's Pool Supplies (DBA)Phoenix, AZ

DIVE IN TO A NEW CAREER WITH LESLIE'S: Leslie's Pool Supplies is the "World's Largest Retailer of Swimming Pool Supplies." With over 1,000+ retail stores in 39 states plus PRO, Service, E-Commerce, Production, and Distribution divisions, there are many career opportunities at Leslie's. With over 60 years of providing best-in-class products and solutions to our customers, there is nothing that we value more than the development and growth of our team. We strive to create a positive and fun atmosphere where our Team Members feel valued and are enthusiastic about the contributions they make to the success of Leslie's. Job Overview: We are seeking a highly motivated and experienced Lead QA with expertise in Point of Sale (POS) systems. Oracle X-Store is preferred, but those with experience on other large-scale POS platforms are encouraged to apply. This role involves creating and executing test plans, troubleshooting, identifying defects, and collaborating with the development teams to ensure the large-scale delivery of our POS solutions. Additionally, this position will monitor contract retail system QAs on-boarded to support various enhancement projects, ensuring that QA standards are followed and quality work product is delivered. Responsibilities: Lead QA strategy and execution for POS systems and related retail technologies. Develop and manage test plans for functional, integration, and regression testing. Collaborate with cross-functional teams to align testing with business needs. Oversee automation efforts and improve test coverage across store systems. Manage defect tracking, triage, and resolution with development teams. Validate POS software updates in lab and store environments before release. Ensure quality across retail systems like inventory, payments, CRM, and loyalty Mentor QA team members and promote best practices. Support performance, load, and security testing efforts. Drive continuous improvement in QA processes and tools. Qualifications: 5+ years of experience in QA, with significant emphasis on POS. In depth understanding of POS systems, including hardware and software and Omni channel integrations, reporting, and logs. Knowledgeable in Windows based systems experience and Mobile POS - Windows and Android. Experience with card acceptance validation, Major and Private label. Verifone terminal, direct to processor experience. Experience with various testing methodologies, including functional, regression, and integration testing. Strong QA process documentation skills. Familiarity with defect tracking in JIRA. Proficiency in SQL for database testing. Experience with automation testing frameworks. Excellent communication and collaboration skills with both internal and external vendor partners. Strong analytical and problem-solving skills. Ability to work independently and as part of a team. Detail-oriented. Ability to prioritize tasks and meet deadlines. Leslie's provides a robust benefits package, including: Comprehensive medical, pharmacy, dental, & vision plan options. Health savings account (with enrollment in the high deductible health plan option). Health & dependent care flexible spending accounts. Company-paid basic life and AD&D insurance. Voluntary supplemental life insurance. Company-paid short-term disability and voluntary long-term disability insurance. Pre-tax and Roth 401(k) with company match. Paid vacation, sick, and bereavement leave. Paid holidays, including a floating personal day. Employee assistance and wellness programs. Earned Wage access is available, allowing early access to a portion of your earned wages before payday. Product discounts at Leslie's Retail stores. Leslie's recognizes a critical component to our continued success is our people. Leslie's is committed to developing and fostering a culture of diversity and inclusion within our company and the communities we serve. A key aspect of building a great team is valuing ideas from many viewpoints, which is why we place a priority on identifying and hiring talented individuals from all backgrounds and perspectives.

Posted 1 day ago

Tech/Render QA Engineer (World Of Warships: Legends)

Wargaming AmericaBelgrade, MT

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

Posted 30+ days ago

Manager/ Senior Manager - Gxp Quality Systems (QA Vendor Management)

Ionis Pharmaceuticals Inc.Carlsbad, CA

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

Posted 4 weeks ago

QA Document Specialist

Oil States International, Inc.Arlington, TX

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

Posted 3 weeks ago

Senior Content Management Analyst- Tax QA

Wolters KluwerWichita, KS

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

Posted 30+ days ago

Senior QA Analyst, Product Engineering

Autodesk Inc.Portland, OR

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

Posted 30+ days ago

Quality Assurance (Qa) Manager, SME

CACI International Inc.Doral, FL

Quality Assurance (QA) Manager, SME Job Category: Information Technology Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: Up to 10% Type of Travel: Local The Opportunity: CACI is seeking an highly experienced Quality Assurance (QA) Manager, SME to U.S. Southern Command (USSOUTHCOM) in Doral, FL. This position is contingent upon award of the USSOUTHCOM Cyber Information Technology Enterprise Services (SCITES II) contract. Responsibilities: Serves as the lead for ensuring quality of work performed under this TO meets the customer expectations and objectives Works in coordination with the Mission Enterprise Services Management Office (MESMO) to provide timely acknowledgement and coordination of requests, problem identification, root cause analysis, escalation, resolution, and closure for all issues Provides support in business planning and implements new strategic initiatives to improve business processes Understands customer needs, helps to define prioritization and sequencing, and leads activities Leads key discussions from both business and technical perspectives Contributes to a QMP and maintains/updates changes in the program processes Manages expectations and objectives by detailing the application of the appropriate methodology (e.g., quality control and/or quality assurance) for accomplishing TO performance Identifies and reports on risks and opportunities for improvement Supports technical working groups and program deliverables (such as the PMP) as needed Provides technical/management leadership on major tasks or technology assignments Possesses domain and expert technical knowledge May supervise others Qualifications: Required: Bachelor's degree in related field of study 13+ years of relevant experience US citizen with active Secret security clearance Expert in quality assurance processes, with particular emphasis on meeting customer expectations and objectives. Possesses comprehensive knowledge of problem identification, root cause analysis, and issue resolution, coordinating effectively with stakeholders. Exhibits strategic expertise in business planning, process improvement, and leading key discussions from both business and technical perspectives. Demonstrates proficiency in developing and maintaining Quality Management Plans (QMP), managing expectations through appropriate methodologies, and identifying risks and opportunities for improvement. Desired: Integrated Master Scheduler - PMI certification Desired background in military IT environments and experience supervising teams ____ What You Can Expect: A culture of integrity. At CACI, we place character and innovation at the center of everything we do. As a valued team member, you'll be part of a high-performing group dedicated to our customer's missions and driven by a higher purpose - to ensure the safety of our nation. An environment of trust. CACI values the unique contributions that every employee brings to our company and our customers - every day. You'll have the autonomy to take the time you need through a unique flexible time off benefit and have access to robust learning resources to make your ambitions a reality. A focus on continuous growth. Together, we will advance our nation's most critical missions, build on our lengthy track record of business success, and find opportunities to break new ground - in your career and in our legacy. Your potential is limitless. So is ours. Learn more about CACI here. ____ Pay Range: There are a host of factors that can influence final salary including, but not limited to, geographic location, Federal Government contract labor categories and contract wage rates, relevant prior work experience, specific skills and competencies, education, and certifications. Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives. We offer competitive compensation, benefits and learning and development opportunities. Our broad and competitive mix of benefits options is designed to support and protect employees and their families. At CACI, you will receive comprehensive benefits such as; healthcare, wellness, financial, retirement, family support, continuing education, and time off benefits. Learn more here. The proposed salary range for this position is: $105,100-$231,100 CACI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, age, national origin, disability, status as a protected veteran, or any other protected characteristic.

Posted 2 weeks ago

Associate QA Engineer

AmadeusBogota, NJ

Job Title Associate QA Engineer External Job Title: QA Engineer Position type: Permanent Location: Bogota, Hybrid Job ID: Job family: Product Quality Assurance About Your Business Area/Department: Flying is easy, isn't it? You are used to catching planes to fly all around the world. Check in, print your boarding passes, drop your bags, go through the security, then board the plane... it's no rocket science. Is it really that simple? Do you really know how it works behind the scenes? Are you curious to know what it takes to be cleared to fly by the regulatory authorities? How the check-in agent will charge you for excess baggage or kindly waive the excess? Have you ever wondered what happens when a flight is delayed or cancelled? How does the airline make sure that you get your connecting flight? This is a very complex business, always changing, where any mistake can severely damage the airline reputation and business, and where all airlines have their set of specificities that we need to accommodate. We are managing the world leading airline Passenger Servicing System - a system that provides check-in and boarding services to approximately 150 airlines and 1 billion passengers each year. We're looking for enthusiastic QA Engineers to work with our developers and product analysts and help us to assurance the quality of the solutions and fixes delivered to our customers in our Departure Control System (DCS) product of Customer Management to address these. The role is based at our Bogota development center. You will join the team that maintains the software that handles the complex logic to manage the baggage, ancillary, regulatory and all processes related to flights at the core of the Amadeus DCS Customer Management application. Summary of the role: As a QA your mission is to create detailed test plans, execute tests and evidence the proper functionality of features and fixes, also report issues when apply for our Customer Management system, always focused on providing the best travel experience to our customers. Works autonomously within defined processes and procedures or methodologies, takes standard decisions and may support the development of solutions to complex problems of a recurring nature. Receives instruction, guidance and direction from more senior level roles or manager, with regular monitoring on the status of the assignments. May have specialized formal education or the equivalent work experience and has the required technical and functional skills and basic knowledge of the business. In this role you'll: Test strategy Attend to specification reviews (also on customer specification reviews when applicable), and provide feedback along with any potential impact, risk, issue or missed gap based on experience, Define test strategy and test plan containing test cases (functional and non-functional), ensure traceability with specifications and customer requirements, Ensure compliance of test strategy with CI/CD guidelines, Green IT guidelines and all quality guidelines (SDL, STDL), QA best practices/standards from the industry (ISTQB..), Test expertise Design test cases and write test case scripts Prepare test environment, test data, and execute test cases Provide sign-off (go/no-go) on tested features based on defined exit criteria Defect management Open defects for software or documentation, assign relevant level of severity based on the importance of the issue, provide relevant investigation and information to fix defects Check defect fix, and give go/no-go for the load of production defects Reporting Report and communicate on test activities to the line organization, software developers and product definitions analysts Provide visibility on testing campaign/milestones to all stakeholders Quality assurance ambassador Show accountability for the project, product or release quality control Technicity Efficiently use QA tooling stack and frameworks Be proactive about any issue/change that is likely to affect QA peers daily job Continuous and sustainable improvement Participate to the understanding, measurement and reduction of the environmental impact of the tested applications and associated QA activities · About the ideal candidate: Excellent analysis & research skills Experience in Agile frameworks Kanban/Scrum/SAFe Ability to write clear and structured documentation Fluency in English Good written and verbal communication, ability to do presentations to large groups Ability to interact and communicate successfully with business partners and technology teams Experience as a Quality Analyst Nice to have Test Automation Experience Tools & Technologies: Jira, Office Suite, Octane, SQL What we can offer you: Get rewarded with competitive remuneration, individual and company annual bonus, vacation and holiday paid time off, health insurances and other competitive benefits. Work from anywhere: onsite, hybrid or fully remote. Professional development to broaden your knowledge and enhance your skills with on-line learning hubs packed with technical and soft skills training that allow you to develop and grow. Enter a diverse and inclusive workplace, join one of the world's top travel technology companies and take on a role that impacts millions of travelers around the globe. Application process: The application process takes no longer than 10 minutes! Create your candidate profile, upload your Resume/CV and apply today! Working at Amadeus, you will find: A critical mission and purpose- At Amadeus, you will be powering the future of travel and pursuing a critical mission and extraordinary purpose. A truly global DNA - Everything at Amadeus is global, from our people to our business, which translates into our footprint, processes, and culture. Great opportunities to learn- Learning happens all the time and in many ways at Amadeus, through on-the-job training, formal learning activities, and day-to-day interactions with colleagues. A caring environment- Amadeus fosters a caring environment, nurturing both a fulfilling career and personal and family life. We care about our employees and strive to provide a supportive work environment. A complete rewards offer- Amadeus provides attractive remuneration packages, covering all essential components of a competitive reward offer, including salary, bonus, equity, and benefits. A flexible working model- We want our employees to do their best work, wherever and however it works best for them. A diverse and inclusive community- We are committed to leveraging our uniquely diverse population to drive innovation, creativity, and collaboration across our organization. A Reliable Company- Trust and reliability are fundamental values that drive our actions and shape long-lasting relationships with our customers, partners, and employees Diversity & Inclusion Amadeus aspires to be a leader in Diversity, Equity and Inclusion in the tech industry, enabling every employee to reach their full potential by fostering a culture of belonging and fair treatment, attracting the best talent from all backgrounds, and as a role model for an inclusive employee experience. Amadeus is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to gender, race, ethnicity, sexual orientation, age, beliefs, disability or any other characteristics protected by law.

Posted 30+ days ago

Assistant Manager QA

Elanco Animal Health IncorporatedMumbai, IN

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

Posted 30+ days ago

QA Supervisor

California DairiesTurlock, CA

Join the California Dairies, Inc. (CDI) team, a farmer-owned cooperative dedicated to sustainably producing the highest quality dairy products while fostering a culture of innovation and collaboration. CDI products are delivered locally and around the world. Situated in Stanislaus County, our Turlock South manufacturing plant specializes in the production of butter and milk powder. We encourage you to be part of our team that's shaping the future of dairy, right from the heart of California! We offer a generous total rewards package that includes: Salary Range $67,848 - $100.855 Family medical/dental/vision Generous company contributions to 401k Relocation Assistance 11 Paid holidays Paid vacation Tuition reimbursement Job Summary The Quality Assurance Supervisor will be responsible to support and maintain the company Quality Systems programs, support and enforce the SQF, QA, GMP, and Safety policies and procedures including production needs, support and assist in maintaining the HACCP program and its pre-requisite programs, support and maintain the Food Safety/Food Security/Biosecurity programs, and aid in customer complaint investigations and response. Essential Functions Oversee the butter and powder hold and release program. Ensure that product releases are done in a timely manner. Take over the hold and release of products in the absence of the Product Control Specialist. Assist the Quality Assurance Manager with the following duties: Aid in the review of microbiology test results daily and further investigate high counts. Physically inspect known or likely trouble points of potential contamination with production management. Aid in the review of plant documents and inspections to ensure all procedures are being followed: Aid in the inspection of dryers during down time, and ensure forms are properly filled out and all the critical parameters are addressed. Aid in the pre-inspections leading towards audits to ensure no infractions are found during the walk through. Aid in new pre-start up inspections for all major equipment. Aid in the maintenance of all plant audit related forms and binders to ensure everything is properly filled out, such as: Daily/Monthly glass, plastic brittle and ceramics inspections. Daily/Weekly/Monthly/Quarterly pest control inspections. Oversee daily equipment calibrations. Understanding of SOPs- Micro, chemical, and procedures. Ensure technicians calibrate load out and receiving thermometers daily. Ensure technicians calibrate all other thermometers weekly. Ensure NIST certified thermometers are re-calibrated annually. Aid in the master sanitation programs to ensure high compliance rate at the end of the month. Oversee the review of CIP records daily - investigate and report any cleaning problems or deficiencies. Generate a Preventative Measure if needed and consult with plant management for implementation approach. Assist QA Manager with the Appendix N program administration. Aid in the inspection of codes for both finish powder and butter (Tipton, Visalia, Fresno, Turlock South) daily. Aid in the inspection finish package appearance daily for both butter (Tipton, Visalia, Fresno, Turlock South) and powder. Will be responsible for all Quality Assurance Manager tasks during vacation or leave. Excellent regular full-time attendance in support of company objectives. Follow all safety and working rules. Must have the ability to get along with co-workers, management personnel, customers, vendors, and employees in accordance with the company policies and working rules while ensuring a harmonious and conducive work environment. Maintain a positive attitude and contribute towards a quality environment. Use initiative and judgment in making decisions, keeping with California Dairies Inc. best interests. Assist in quality assurance and any other areas of the plant when necessary. Perform other duties as assigned by management. Supervisory Responsibilities This position has employee supervisory responsibilities for the QA Technicians in the area of discipline. Responsible for overall job training and development of all technicians that directly report to QA Supervisor. Generate Lab Technician's schedule. Oversee overall performance of all Technicians, including performance reviews. If there are employee problems, you are to report them to your HR manager and QA Manager. Have the responsibility of calling in employees if needed to cover a shift. 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 with disabilities to perform the essential functions. Must work in a safe manner and follow all safety procedures including use of safety equipment. Must be willing to ask for assistance when the process is unclear. Must have good organizational and communication skills. Must be able to provide training to employees through Power Point presentations. Must be able to work flexible hours and weekends. Must be proficient with Microsoft Outlook, Publisher, Word, Excel, and Power Point programs. Microsoft Visio is a plus. Education and/or Experience A BS degree in Dairy or Food Science or other related field and four years of experience in a leadership role; or an equivalent combination of education and experience are required in five (5) out of the last ten (10) years. College level verbal and written communication skills. Advanced computational skills required. Good math reasoning required. Excellent organizational and follow through skills. Ability to self-direct work to a timely completion. Excellent written and spoken English. Language Skills English is required as the spoken language. Other languages are a definite asset. A well-modulated tonal volume is required with excellent diction skills needed. Reasoning Ability Must have the ability to apply common sense understanding to carry out instructions given in written, oral, or diagram form. Must have the ability to discern when issues may require input from levels or authority within the corporation. Must have ability to read, interpret, and convey applicable regulatory requirements and regulations. Certificates, Licenses, Registrations Must possess or be able to obtain California State Pasteurizers License and California State Sampler's and Weigher's License. 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 this job. The company will make reasonable accommodations that do not cause undue hardship if such an accommodation enables individuals with disabilities to perform the essential functions of the position. Sitting/Standing/Walking: The supervisor spends about 75% of the workday standing or walking. They sit while entering data or using the computer. The supervisor walks on uneven gravel, dirt, concrete, and tile surfaces. Lifting/Carrying: Occasional lifting requirements as job demands. Must be able to lift a minimum of 40 lbs. on an occasional basis. Pushing/Pulling: Occasional pushing or pulling requirements. Bending/Stooping: Occasional bending and stooping requirements. Squatting/Kneeling/Crawling: Occasional kneeling or crawling requirements. Twisting/Turning: Ongoing twisting or turning requirements. Climbing/Balancing: Climbing and balancing is required during plant inspections, and other related job requirements. Reaching: Ongoing reaching requirements associated with job requirements. Grasping/Manipulating: Grasping and manipulating of papers, objects, and equipment will be required. The ability to use a keyboard for data input will be required on an ongoing basis. Equipment (where applicable) CEM SMART System 5 Charm Science Rosa Reader Charm Science EZ Reader Charm II by Charm Sciences Advanced Cryoscope Perten Instruments FOSS FT 1 FOSS FT 2 FOSS DS3 FOSS Process Scan FOSS Pro-Foss WAL Analyzer Coders, Metal Detectors, Etc. Mettler Toledo Karl Fischer-V20 Computer Thermometers Scales pH Meters Incubators Titrations Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The company will make reasonable accommodations that do not cause undue hardship if such an accommodation enables individuals with disabilities to perform the essential functions of the position. Employees will be subject to temperatures associated with an air-cooled room. Temperatures range from 34 to 120 degrees. ADA/FEHA The Company will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 and California's Fair Employment and Housing Act. EEO The Company is an equal employment opportunity employer.

Posted 2 weeks ago

Senior Content Management Analyst- Tax QA

Wolters KluwerKennesaw, GA

Posted 30+ days ago

Construction Qa/Qc Specialist - Disaster Recovery

ICF International, IncTampa, 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. 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

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 3 weeks ago

Senior Operations QA Manager - Clinical

Exelixis Inc.Alameda, CA

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

Posted 2 weeks ago

QA Training Specialist

Gilead Sciences, Inc.Foster City, CA

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Job Responsibilities Manages the development and implementation of learning programs to meet compliance goals, development needs, and operational excellence initiatives. Supports the coordination of training sessions including scheduling, documentation, learning management system administration and update training materials. Under direction of the Head of QA Learning and Performance, leads the communication efforts of available learning programs, including, updating the SharePoint site and internal social media. Supports the creation of communication and learning materials such as: PowerPoint decks, workbooks, flyers, e-mails, newsletters, and videos. • Normally receives direct instruction on routine work Supports the evaluation of training effectiveness and monitoring Knowledge Demonstrates understanding of training, instructional design, communication, and/or education. Demonstrates understanding of pharmaceutical manufacturing and quality assurance. Demonstrates working knowledge of current Good Manufacturing Practices (GMPs). Demonstrates functional and process knowledge to support training programs. Demonstrates strong verbal, written, and interpersonal communication skills. Demonstrates proficiency in Microsoft Office applications. Experience with managing e-Learning modules Specific Education & Experience Requirements 4+ years of relevant experience and a BS or BA degree. 2+ years of relevant experience and a MS degree. Prior experience in pharmaceutical industry is preferred. The salary range for this position is: $102,085.00 - $132,110.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 1 week ago

QA / QC Manager, Bond Civil & Utility, Manhattan, New York

Bond Brothers, Inc.New York, NY

Position Description: The Project Quality Manager is responsible for aspects of quality on assigned projects. This role leads the development of the Quality Assurance Plan in accordance with client specifications and industry standards, drives compliance with the QAP through development and implementation of Inspection and Test Plans, provides inspection oversight, and performs quality submissions. The Project Quality Manager also provides technical quality support to the field staff, documents inspections, observations, and works with the client and the project management staff to schedule inspections and testing. This role reports to the Quality Control Program Manager and interacts with stakeholders from the Project Management, Field Operations, clients, consultants, and vendor teams. Must have a minimum of (5) five years of experience with NYCDEP projects. Salary: The base salary for this position is between $135k - $165k Core Responsibilities: Reviews and validates construction documents including plans, specifications, and drawings for accuracy and completeness, and alignment with quality requirements. Educates Project Management team on requirements for inspection and testing services and provides options for qualified third-party companies as required. Advise project team on estimated time and cost drivers associated with project specific quality requirements. Leads development of Project Quality Assurance Plans (QAPs) and Inspection and Test Plans ITPs). Develops quality checklists that align with ITPs, and Client and Industry Standards. Travels to vendor locations for Acceptance and Witness testing for major equipment associated with the project. Perform visual inspections and measurements to verify the quality of workmanship and adherence to project requirements. Manages Inspection and Testing services performed by third parties when required to be provided by BCU. Collects data gathered by all third-party inspection and testing firms, (Inspections, test results, equipment calibrations, etc.) and reviews for accuracy, completeness, and compliance. Identify and document deviations and/or non-compliance issues. Ensure thorough inspections of equipment, material, and work executed occurs and meets the project requirements and inspection methods comply with quality control procedures. Collaborate closely with project managers, engineers, field staff, and clients to provide insight on complex quality issues and provide technical resolution guidance. Accountable for accurate and detailed inspections and observations, including findings, recommendations, and corrective actions. Assist in the development and improvement of quality control procedures and documentation. Stay updated on industry best practices, standards, and regulations related to civil and utility construction quality assurance. Participate in internal and external quality audits and assist with continuous improvement initiatives. Review quality documentation submitted by subcontractors to verify compliance with plan and alignment with project requirements. Maintain accurate and organized documentation control practices, including the preparation of inspections, observations, non-conformance reports, and other quality-related documentation. Develop and provide quality submittal documentation to the project management team as required. Qualifications: BS in engineering or related discipline or equivalent work experience in the construction industry with specific quality control experience. Minimum of (5) years' experience with NYCDEP projects. Familiarity or ability to learn and utilize Procore. Knowledge of mechanical, electrical, and civil construction techniques, equipment, and processes. In-depth understanding of industry standards, codes, and regulations related to utility and site construction. Ability to read and interpret complex drawings, specifications, and quality documents to accurately extract construction requirements. Proficient with inspection tools, equipment, and software applications. Excellent time management and prioritization skills to meet deadlines while providing accurate deliverables. Experience managing personnel in-directly to drive accurate execution of tasks in a timely manner. Proficient with Microsoft office applications and ability to learn new software quickly. Excellent written and oral communication skills with collaborative mindset. Ability to stand, walk, climb, and work in outdoor environments for extended periods of time. Must have a valid driver's license. Willingness to travel primarily within NY/NJ with occasional travel to vendor facilities. Ability to pass a comprehensive drug screening and background check. Preferred Qualifications: Strong technical, analytical, and problem-solving skills. Strong understanding of Quality Control and Assurance practices for Electrical, Gas, and Civil Infrastructure projects. Working knowledge of Public and Private Sector Utilities and Transportation firms' quality requirements. NACE, API 1169, CWI, ICC Inspector, ASQ Quality Inspector, or other professional certifications. Knowledge of common NDE and inspection practices for pipelines, foundations, etc. Strong field construction experience - successful candidates will understand construction sequencing, durations, dependencies, production, and the time and cost implications of failures. Equal Employment Opportunity Policy BOND has a culture of and is committed to treating its employees with dignity and respect and maintaining a work environment that lives by its core values: Integrity, Commitment, Teamwork, Innovation, and Excellence. BOND is an equal opportunity employer and abides by the requirements of the Americans with Disabilities Act (ADA) and we are committed to accommodating those with disabilities. We prohibit discrimination and harassment of any type and afford equal employment opportunities to employees and applicants without regard to race, color, religion, sex/gender, national origin, age, disability, ancestry, veteran status or military obligations, sexual orientation, reproductive health decision making, genetic information, protective hairstyles, domestic violence experience or any other characteristic protected by federal, state or local laws. If you need assistance or accommodation due to a disability, you may contact us at humanresources@bondbrothers.com or at 617-387-6400.

Posted 30+ days ago

Specialist, QA OTF

Catalent Pharma Solutions, Inc.Harmans, MD

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Job Description

Specialist, QA OTF (PM Shift)

Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA On-The-Floor (OTF) oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.

This is a full-time on-site position, 7pm-7am 2-2-3 rotation

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 Role:

Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product- 75% of day is spent on the floor.
Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
Partner with Manufacturing and other support teams
Perform Acceptable Quality Limit (AQL) visual inspection of drug product
Review and approve batch documents for media and buffer prep solutions
Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's
Compile deviations as required when observed on the floor, and move to completion within the required time frame
Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product- 75% of day is spent on the floor.
Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
Make solid quality decisions with limited oversight
Identify and implement and continuous improvement initiatives
Participate in site and corporate quality and process improvement initiatives.
Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
Actively participates in training activities, managing their individual training plan.
Other duties as assigned.

The Candidate:

Masters' degree in a Scientific, Engineering or Biotech field with 0 - 2 years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.

Bachelor's degree in a Scientific, Engineering or Biotech field with 2 - 4 years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
Strong understanding of GMPs (21 CFR Parts 210, 211, 600s), ICH, and EU GMPs. Familiarity with biological manufacturing processes (microbial/cell culture, fermentation, purification, fill/finish).
Knowledgeable in applying scientific and regulatory principles to solve operational and quality tasks.
Familiar with electronic systems (Microsoft products; LIMS, Master Control, Trackwise preferred) and possesses strong analytical, troubleshooting, and decision-making skills.
Adaptable and proactive, capable of learning new processes quickly, working independently and collaboratively to meet deadlines in a fast-paced environment.

The anticipated salary range for this position in Maryland is $74,080 -$101,860 plus shift differential and annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Position Benefits:

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of paid time off annually + 8 paid holidays
Competitive salary with yearly bonus potential
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement

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.