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INCOG BioPharmaFishers, IN
Quality Assurance Specialist, IQC Summary Working closely with the QA Operations Supervisor and IQC Supervisor. QA Specialist will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Specialist, IQC will need to provide support with identifying operational and quality gaps. The Quality Assurance Specialist, IQC will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Specialist, IQC will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Specialist, IQC will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide verification of incoming pharmaceutical shipments and contents against purchase orders, materials specifications and receiving in line with INCOG SOP's. Review and approve documentation, including but not limited to logbooks, material packets, material specifications, packing lists, work orders, procedures, etc. Collaborate with Supply Chain, IQC, and Operations team and lead or provide support with investigations to resolve inventory and material, consumables, and component related deviations. Support other QA personnel from Operations as necessary with batch record reviews, corrections, floor operations, etc. Inspect products for damage, discrepancies, or expired items and report any issues to the Warehouse Manager. Prioritize and coordinate his/her time in balancing timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Provide Quality Assurance oversight into the picking of product Bill of Materials (BOM). Assist Supply Chain Management with Critical Alarm reporting with freezer farm or incubator alarms. Perform both provisional and full release of materials. Dispose of Filled Inspected Product (FIP) rejects following batch disposition. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Assist Operations with incoming and outgoing Material Transfer counts. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Provide Quality Assurance oversight with Supply Chain inventory cycle counts and investigate any discrepancy. Ability to manage multiple projects in a fast-paced environment. Assist in maintaining records for regulatory inspections and audits. Special Job Requirements: This position will support primarily first shift (7:00 am - 3:30 pm) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Logistics, Supply Chain, Management, Biology or Chemistry Minimum of 4 years with experience working as Quality in a GMP Manufacturing environment, Raw Material/ Component/Consumable release and/or as an Operator within a Pharmaceutical Supply Chain/Warehouse environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Ability to obtain Powered Industrial Lift Certification. Excellent written and verbal communication skills. Ability to lift 50 lbs. General computer skills evidenced by hands-on work with inventory management systems; and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing, inspecting finished products, and supply chain or warehousing. Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

Hewlett Packard Enterprise logo
Hewlett Packard EnterpriseSunnyvale, CA

$106,000 - $243,000 / year

QA/Automation Engineer This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever they live, from edge to cloud, so they can turn insights into outcomes at the speed required to thrive in today's complex world. Our culture thrives on finding new and better ways to accelerate what's next. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. If you are looking to stretch and grow your career our culture will embrace you. Open up opportunities with HPE. Job Description: We are looking for a detail-oriented and proactive QA/Automation Engineer to validate and automate testing for Mist Systems' Network Access Control (NAC) product. You will design and execute both manual and automated test cases, ensure seamless integration with Juniper products and third-party identity services, and help maintain high product quality through robust automation. Key Responsibilities: Design, develop, and execute manual and automated test cases for NAC components (policy enforcement, device onboarding, posture checks, MDM integration, etc.) Collaborate with Product Managers and Developers to create comprehensive test plans Validate integrations with Mist Dashboard, Juniper switches, access points, and external identity services (Azure AD, Okta, RADIUS) Automate end-to-end workflows using Python, REST APIs, and relevant frameworks Simulate network conditions using virtual labs or physical testbeds Maintain CI/CD pipelines for automated test execution Perform regression, performance, scalability, and security testing Analyze logs, debug issues, and document detailed bug reports Support debugging of live production customer issues Required Qualifications: Bachelor's degree in Computer Science or related field, Master's degree preferred 5+ years in QA or Automation engineering (networking or security products preferred) Strong networking fundamentals (TCP/IP, VLANs, DHCP, RADIUS, 802.1X, NAC) Automation experience with REST APIs, Python, and related frameworks Cloud-native platform and microservices testing experience Proficiency with Wireshark, Postman, Jenkins, Docker, and Git Excellent troubleshooting, communication, and documentation skills Preferred Qualifications: Experience with Mist Systems, Juniper, or other NAC solutions (Cisco ISE, Aruba ClearPass, FortiNAC) Knowledge of SAML/OAuth2, Azure AD, Okta, Zero Trust, and endpoint posture checks Familiarity with test management/reporting tools (e.g., TestRail) Additional Skills: Cloud Architectures, Cross Domain Knowledge, Design Thinking, Development Fundamentals, DevOps, Distributed Computing, Microservices Fluency, Full Stack Development, Security-First Mindset, Solutions Design, Testing & Automation, User Experience (UX) What We Can Offer You: Health & Wellbeing We strive to provide our team members and their loved ones with a comprehensive suite of benefits that supports their physical, financial and emotional wellbeing. Personal & Professional Development We also invest in your career because the better you are, the better we all are. We have specific programs catered to helping you reach any career goals you have - whether you want to become a knowledge expert in your field or apply your skills to another division. Unconditional Inclusion We are unconditionally inclusive in the way we work and celebrate individual uniqueness. We know varied backgrounds are valued and succeed here. We have the flexibility to manage our work and personal needs. We make bold moves, together, and are a force for good. Let's Stay Connected: Follow @HPECareers on Instagram to see the latest on people, culture and tech at HPE. #unitedstates #networking Job: Engineering Job Level: TCP_03 States with Pay Range Requirement The expected salary/wage range for a U.S.-based hire filling this position is provided below. Actual offer may vary from this range based upon geographic location, work experience, education/training, and/or skill level. If this is a sales role, then the listed salary range reflects combined base salary and target-level sales compensation pay. If this is a non-sales role, then the listed salary range reflects base salary only. Variable incentives may also be offered. Information about employee benefits offered can be found at https://myhperewards.com/main/new-hire-enrollment.html . USD Annual Salary: $106,000.00 - $243,000.00 HPE is an Equal Employment Opportunity/ Veterans/Disabled/LGBT employer. We do not discriminate on the basis of race, gender, or any other protected category, and all decisions we make are made on the basis of qualifications, merit, and business need. Our goal is to be one global team that is representative of our customers, in an inclusive environment where we can continue to innovate and grow together. Please click here: Equal Employment Opportunity. Hewlett Packard Enterprise is EEO Protected Veteran/ Individual with Disabilities. HPE will comply with all applicable laws related to employer use of arrest and conviction records, including laws requiring employers to consider for employment qualified applicants with criminal histories. No Fees Notice & Recruitment Fraud Disclaimer It has come to HPE's attention that there has been an increase in recruitment fraud whereby scammer impersonate HPE or HPE-authorized recruiting agencies and offer fake employment opportunities to candidates. These scammers often seek to obtain personal information or money from candidates. Please note that Hewlett Packard Enterprise (HPE), its direct and indirect subsidiaries and affiliated companies, and its authorized recruitment agencies/vendors will never charge any candidate a registration fee, hiring fee, or any other fee in connection with its recruitment and hiring process. The credentials of any hiring agency that claims to be working with HPE for recruitment of talent should be verified by candidates and candidates shall be solely responsible to conduct such verification. Any candidate/individual who relies on the erroneous representations made by fraudulent employment agencies does so at their own risk, and HPE disclaims liability for any damages or claims that may result from any such communication.

Posted 2 weeks ago

Gatik logo
GatikDetroit, MI
Who we are Gatik, the leader in autonomous middle-mile logistics, is revolutionizing the B2B supply chain with its autonomous transportation-as-a-service (ATaaS) solution and prioritizing safe, consistent deliveries while streamlining freight movement by reducing congestion. The company focuses on short-haul, B2B logistics for Fortune 500 retailers and in 2021 launched the world's first fully driverless commercial transportation service with Walmart. Gatik's Class 3-7 autonomous trucks are commercially deployed across major markets, including Texas, Arkansas, and Ontario, Canada, driving innovation in freight transportation. The company's proprietary Level 4 autonomous technology, Gatik Carrier, is custom-built to transport freight safely and efficiently between pick-up and drop-off locations on the middle mile. With robust capabilities in both highway and urban environments, Gatik Carrier serves as an all-encompassing solution that integrates advanced software and hardware powering the fleet, facilitating effortless integration into customers' logistics operations. About the role You'll play a key role in bridging the gap between product design and scalable production. You will lead the manufacturing process for autonomy hardware integration into trucks, troubleshoot on-site build issues, and drive quality assurance initiatives to ensure high reliability and production efficiency. This is a hands-on, on-site role that requires close collaboration with cross-functional teams and external manufacturing partners. What you'll do Lead the end-to-end manufacturing process for integrating autonomy hardware into trucks. Develop and maintain assembly procedures, inspection checklists, and documentation to ensure build consistency and traceability. Collaborate closely with the design, integration, and production teams to rapidly resolve build issues and implement corrective actions. Define and implement QA processes including inspection plans, failure analysis protocols, and defect tracking. Analyze quality data and product metrics to identify trends, systemic issues, and opportunities for improvement. Lead build events and validation activities, including first article inspections and in-process audits. Drive continuous improvement initiatives across manufacturing and QA processes to increase reliability and throughput. Serve as a key technical resource at the manufacturing site, escalating issues and coordinating solutions with internal engineering teams. Collaborate with Contract Manufacturer to establish processes Perform various tests and inspections on raw materials, parts and finished trucks to verify that specified processes are met Ensure and adhere to industry standards, regulations, and company policies What we're looking for 7+ years of experience in manufacturing engineering, quality engineering, or related roles in automotive, aerospace, or hardware tech industries. Strong hands-on experience with electromechanical systems, harness routing, sensor installation, and system-level testing. Familiarity with manufacturing process control, quality standards, and root cause analysis tools Ability to read and interpret engineering drawings, wiring diagrams, and specifications. Excellent problem-solving skills and a detail-oriented mindset with a bias for action. Comfortable working on-site in a dynamic and collaborative production environment. Proficiency with QA and documentation tools (e.g., PLM systems, spreadsheets, issue trackers like JIRA). Bachelor's degree in Mechanical, Electrical, Industrial Engineering, or related technical field. More about Gatik Founded in 2017 by experts in autonomous vehicle technology, Gatik has rapidly expanded its presence to Mountain View, Dallas-Fort Worth, Arkansas, and Toronto. As the first and only company to achieve fully driverless middle-mile commercial deliveries, Gatik holds a unique and defensible position in the AV industry, with a clear trajectory toward sustainable growth and profitability. We have delivered complete, proprietary AV technology - an integration of software and hardware - to enable earlier successes for our clients in constrained Level 4 autonomy. By choosing the middle mile - with defined point-to-point delivery, we have simplified some of the more complex AV challenges, enabling us to achieve full autonomy ahead of competitors. Given extensive knowledge of Gatik's well-defined, fixed route ODDs and hybrid architecture, we are able to hyper-optimize our models with exponentially less data, establish gate-keeping mechanisms to maintain explainability, and ensure continued safety of the system for unmanned operations. Visit us at Gatik for more company information and Careers at Gatik for more open roles. Notable News Forbes: Forget robotaxis. Upstart Gatik sees middle-mile deliveries as the path to profitable AVs Tech Brew: Gatik AI exec unpacks the regulations that could shape the AV industry Business Wire: Gatik Paves the Way for Safe Driverless Operations ('Freight-Only') at Scale with Industry-First Third-Party Safety Assessment Framework Auto Futures: Autonomous Trucking Group Gatik Secures Investment From NIPPON EXPRESS HOLDINGS Automotive News: Gatik foresees hundreds of self-driving trucks on road soon, and that's just the beginning Forbes: Isuzu And Gatik Go All In To Scale Up Driverless Freight Services Bloomberg: Autonomous Vehicle Startup Takes Off by Picking Off Easier Routes Reuters: Driverless vehicles on limited routes bump along despite US robotaxi scrutiny Taking care of our team At Gatik, we connect people of extraordinary talent and experience to an opportunity to create a more resilient supply chain and contribute to our environment's sustainability. We are diverse in our backgrounds and perspectives yet united by a bold vision and shared commitment to our values. Our culture emphasizes the importance of collaboration, respect and agility. We at Gatik strive to create a diverse and inclusive environment where everyone feels they have opportunities to succeed and grow because we know that together we can do great things. We are committed to an inclusive and diverse team. We do not discriminate based on race, color, ethnicity, ancestry, national origin, religion, sex, gender, gender identity, gender expression, sexual orientation, age, disability, veteran status, genetic information, marital status or any legally protected status.

Posted 3 weeks ago

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BridgeBio Pharma, Inc.San Francisco, CA
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Manager, Computer System Validation (CSV), QA will report to the Associate Director, Quality Assurance (QA). This position will provide quality oversight of the computer system validation lifecycle from design and implementation to retirement, ensuring compliance of GxP applications. This role will ensure that all GxP computerized systems, including Veeva, Argus, SAP, Tracelink, etc., are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP 5, and other Health Authority requirements. The ideal candidate will combine technical expertise in CSV, strong quality systems acumen, and exceptional cross-functional communication skills. Responsibilities Provide QA oversight of the GxP computer system validation lifecycle, ensuring ongoing compliance and validated state through design, configuration, updates, and maintenance Review and approve IT change control and validation deliverables, including protocols, test scripts, and reports of the GxP validated system Evaluate risk assessments and determine the impact of changes/updates on user experience, system performance, and compliance Participate, review, and approve periodic system reviews and release management activities, identifying and remediating compliance gaps Collaborate with IT, cross-functional stakeholders such as business owners, to establish and enforce requirements for system validation, data integrity, and ongoing system maintenance Drive continuous improvement initiatives for QMS and validated GxP systems Support regulatory inspections and audits, ensuring adherence to 21 CFR Part 11, EU Annex 11, GxP, and other regulatory frameworks Support inspection remediation activities and CAPA management through timely resolution and closure Collaborate with cross-functional teams to optimize workflows, reporting capabilities, and system usability for business and compliance needs Review and approve GxP-computer system SOPs, and support end-user training to ensure proper adoption and compliance Serve as QA CSV subject matter expert (SME) and provide guidance on risk-based validation strategies (CSV/CSA) Where You'll Work This position can be a hybrid role which requires in-office collaboration 2-3x per week in our San Francisco Office. This position can also be considered for U.S-based remote role, that will require quarterly, or as needed visits to our San Francisco Office. Who You Are Bachelor's or Master's degree in software, computer engineering, or technical field 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies Excellent attention to detail and strong organizational skills Effective communication skills both written and verbal Demonstrated expertise in GxP computerized system validation (CSV/CSA) and system lifecycle management Strong working knowledge of regulatory requirements, including: 21 CFR Part 11 EU Annex 11 ICH Q10 GAMP 5 Hands-on experience with computer system validated platforms (Veeva eTMF, Quality, QMS, RIM; SAP; Argus; Tracelink) Experience developing GxP SOPs and training personnel on compliance requirements Ability to work independently and collaboratively within a team Ability to influence and drive cross-functional teams Familiarity with risk-based validation methodologies (CSV/CSA) Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Posted 30+ days ago

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Wargaming AmericaBelgrade, MT
Job Overview Wargaming is looking for а QA Engineer to work on World of Warships: Legends in our Belgrade office. World of Warships: Legends is a cross-platform gaming project. It is a free-to-play naval action MMO that puts players in command of some of the most iconic ships in history. In the LiveOps team, we design, develop, and deliver content for a wide range of in-game events and activities. We work closely with various development, RnD and publishing teams to fill our game with unique, high-quality content. We turn data and creativity into memorable player experiences. Reports to LiveOps Team Lead What will you do? Design test plans, test cases, and prepare the test environment. Perform manual functional, regression, and acceptance testing on various platforms. Create and maintain errors in the bug tracker. Launch automated tests, analyze their results and prepare respective reports. Create and maintain up-to-date test documentation. Participate in planning new features for the project, analysis of new documentation, and interaction with development teams. What are we looking for? 2+ years of QA experience. Knowledge of testing methods and techniques. Experience in developing test scenarios (test cases and checklists). Passionate about gaming. Experience with version control systems (Git, SVN). Experience with bug tracking systems. Experience with Testrail, Allure, or others. Understanding of performance testing. Knowledge of JSON and XML. English B2 or higher. What additional skills will help you stand out? Knowledge of SDLC. Understanding of client-server communication. Experience in GameDev. Experience in mobile/console games testing. Knowledge of the Russian language. Work mode On-site during probation period (first 3 months) and Hybrid (2-3 days of work from the office after probation period). Benefits Benefits and perks are tailored to the local market and culture. Our benefits in Belgrade include: Additional vacation days based on years of service at Wargaming: up to 5 days on top of the statutory minimum 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

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Legend Biotech CorpRaritan, NJ

$75,972 - $99,713 / year

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist III as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 1st Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The anticipated base pay range is $75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Posted 30+ days ago

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Lebermuth, Inc.South Bend, IN
Apply Job Type Full-time Description Lebermuth Company is currently looking for a Quality Assurance Compliance Specialist to join our team. Lebermuth Company, a family-owned leader in the fragrance and flavor industry, has been blending tradition with innovation for over a century. Specializing in essential oils, fragrances, and flavors, Lebermuth is dedicated to quality and integrity. Our commitment to excellence is evident in our personal touch, sustainable practices, and customer-centric approach. Summary: The QA Compliance Specialist is responsible for administering and coordinating quality programs to ensure compliance with FDA, FSMA, SQF, HACCP, and other applicable state and federal regulations. This role partners with procurement and cross-functional teams to maintain a robust supplier quality program and supports continuous improvement initiatives across the organization. Essential Duties & Responsibilities: Serves as the primary SQF Practitioner and PCQI; oversees Verification & Validation, Document Control, Foreign Material Management, and Environmental Monitoring programs. Manages Pest Control Programs and 3rd party contractors supporting Quality and Food Safety initiatives. Facilitates 3rd-party laboratory testing for raw materials and finished products to meet EPA/FDA and certification requirements (e.g., Organic). Responsible for managing the Supplier Approval Program by overseeing supplier level approvals, partnering with regulatory team to maintain accurate and current supplier data, and administering the Supplier Approval Database to ensure compliance and program integrity Administers the Alchemy training program; collaborates with QEHS and other departments on annual training needs. Leads internal auditing program; communicates schedules and results to leadership. Facilitates corrective and preventive action (CAPA) processes to drive continuous improvement. Supports Regulatory department during governmental, third-party, and customer audits. Promote food safety culture by maintaining a clean and organized workspace and adhering to all quality and safety standards within the department to ensure the safe production and shipment of quality food products Performs other duties as assigned to support compliance and quality objectives. Requirements Qualifications: Education: Bachelor's degree in food science, Quality Assurance, Business, or related fields of study, or an equivalent combination of education and experience. Experience: 2+ years of related experience and/or training; Knowledge base representative of the position includes experience with SQF, cGMP and HACCP programs. Certifications: SQF Practitioner, PCQI, and HACCP. Functional Skills: Strong planning, organizational, and executing skills are required; technical aptitude, with lean thinking/process improvement skillsets, are needed to problem-solve and enhance the operations; excellent forward-thinking, prioritization, analytical, and detail-oriented skills are required to manage multiple data points. Analytical problem solving, effective communication and partnership development Technology Aptitude/Skills: Basic knowledge of computer and keyboard functions. Strong working knowledge and experience with MRP/ERP systems and familiarity with regulatory-related programs. Proficiency with Microsoft Office products, particularly Excel. Language Skills: Strong verbal and written communication skills. Demonstrates advanced group presentation skills, presents information effectively and responds to questions from owners and management teams Ability to read, analyze and interpret professional journals, technical procedures, governmental regulations, and chemical hazard information and safety procedures. Ability to write correspondence that is professional in both content and tone. Ability to effectively present information and respond to questions. Leadership/Behavior Skills: Self-motivated to stay focused on quality and output goals; strong work ethic and values, sound judgement, dependable, focused on the customer and processes; high level of accuracy and attention to detail with the flexibility to move to priorities throughout the operation areas, following all Safety requirements Culture Match Behaviors: Enjoys and thrives in a fast-paced, high-growth environment, with a huge drive to create an impact while also being an effective listener, respectful problem-solver and a collaborative continuous learning team member. Physical and Sensory Demands / Environmental Conditions / Equipment Used This role routinely uses standard office equipment such as computers, phones, electronic devices, photocopiers, filing systems/cabinets and fax machines. Ability to operate keyboard and view computer screen occasionally. Ability to write ideas/information in a logical flow occasionally. Cognitive and reasoning ability to read, review and interpret work orders or processes on a frequent basis. Ability to read and respond due to nature of the work on a frequent basis. Ability to talk and communicate with others via phone, in-person, and/or computer frequently. Ability to listen to others, solve problems, and respond frequently. Ability to stand, sit, walk, climb, bend, stoop, kneel, crouch, reach, squat, twist, push, pull, and carry items frequently. Ability to lift/move up to 15lbs sporadically. Ability to work in a manufacturing environment with fluctuating temperatures and noise levels. The employee is required to wear suitable Personal Protective Equipment such as safety glasses, hair/beard nets and steel toed shoes, as required. Work schedule is generally 1st shift, generally Monday through Friday, but at times requires on-call and non-traditional work hours, to meet business needs Salary Description Hourly Non Exempt

Posted 1 week ago

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MiMedx Group Inc.Kennesaw, GA

$18 - $28 / hour

At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally. Will you join us on this journey? We are excited to add Senior QA Product Release Associate to our Quality Assurance team! This role will be a on site. The position will pay between $18.00-28.00 per hour based on previous relevant experience and educational credentials. POSITION SUMMARY: Will review documentation of actual process performed in the manufacture of any/all products to ensure compliance with all standard operating procedures (SOP's) and applicable regulations. Inspect all new products and determine their acceptability for release for distribution/shipment; inspect returned products to make final disposition determination. Work to resolve identified errors and deviations, review and maintain applicable records, and ensure compliance with quality system standards, policies, and procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES: Review documentation records within the CEA completed by technicians during processing of any/all products to ensure proper procedures were followed Identify any errors/deviations in processing records and work with appropriate individual(s) to resolve, and/or submit for review/approval as needed Inspect final products identified as ready for release by packaging technician to determine acceptability for distribution and shipment (e.g. product is in proper packaging, correct label, untampered safety seal, etc.); compare documentation records to visual inspection of product Inspect the condition of all returned products and determine final disposition (e.g. can it be returned to inventory, does it require re-packaging, should it be discarded as waste, etc.) Identify any issues with returned products (e.g. wrong quantity received, opened packaging, etc.; notify management and customer service (who processes returns) Review quality control records to ensure accuracy and acceptability of analytical results including product moisture levels, and out-of-specification investigation documentation, as applicable Make final determination of product availability (new and returned goods) for use; move product both physically and electronically (e.g. inventory database) from packaged goods quarantine room/returned product quarantine to release product storage room Communicate inventory levels related to newly released new product and/or returned products to fulfillment departments (i.e. operations, shipping/storage) Reconciliation of processing records for technician documentation of donor processing Review autoclave logs, equipment maintenance records including environmental monitoring results, and cleaning logs, etc. Manage the transfer of completed, hard copy processing charts and donor records to quality assurance storage areas across different company's facilities; help with inventory activities of all records prior to shipment to off-site storage facilities for record retention and tracking purposes Perform customer validations by verifying product shipping addresses are compliant with regulatory requirements (i.e. being shipped to freestanding healthcare facility); communicate non-compliant issues to customer service Ensure company-wide compliance to quality system standards and procedures; identify, recommend, and assist with the development and implementation of needed improvements PROBLEM SOLVING: Effectively identifies problems as they occur and takes appropriate steps to solve them in situations where the problem is not difficult or complex Refers complex, unusual problems to supervisor DECISION MAKING/SCOPE OF AUTHORITY: Under general supervision, exercises some judgement in accordance with well-defined policies, procedures, techniques Work typically involves regular review of output by a senior coworker or supervisor SPAN OF CONTROL/COMPLEXITY: Fully functioning support role having greater responsibility to perform all (or most) of the standard work within the function; moderate impact to the department EDUCATION/EXPERIENCE: Bachelor's degree in related field or equivalent work experience Specialized skill training; certification may be required Prefer knowledge of AATB, FDA, and other state/federal regulations SKILLS/COMPETENCIES: Excellent oral, written, and interpersonal communication skills Proficient in Microsoft Office (Excel, Word, etc.) Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail Must show aptitude to develop appropriate skills needed for the job WORK ENVIRONMENT: The work is typically performed in a normal office environment, processing lab or warehouse. Role routinely uses standard office equipment; may require use of lab equipment (i.e. refrigerator). Will be required to comply with proper protective equipment guidelines (e.g. gloves, masks, lab coats, etc.), as applicable.

Posted 30+ days ago

CSSI, Inc. logo
CSSI, Inc.College Park, GA
Responsibilities: Review and validation of Mandatory Occurrence Reports (MORs). Investigates surface incidents including runway incursions, vehicle/pedestrian deviations, pilot deviations, ATC loss of separation. As appropriate conducts interviews of pilots. Completes required preliminary reporting forms, i.e., FAA Form 8020-17, for various incidents. Creates replays and retrieves voice recordings to assist in investigation, research, and review of incidents. As requested by the QA Manager prepares reports to support and communicate program status. Communicates with FAA Facilities and other program offices. Purpose of communication is to provide assistance to field facilities concerning QA/QC and Runway Safety issues and share information with other program offices. Contacts field facilities to request information that cannot be obtained through other methods. Minimum Qualifications: Bachelor's degree in math, engineering, or science plus a minimum of 15 years ATC experience in a LVL 8 or higher FAA/military equivalent ATC facility. Educational Requirement: In lieu of an applicable bachelor's degree eight (8) years of relevant experience may be substituted Candidate must able to work out of the Eastern Service Area (College Park, GA office) on a full time basis. Desired Qualifications: Experience as a QA/QC specialist or manager in a field ATC facility, District, Service Center/Service Area office, or at FAA Headquarters About CSSI: CSSI, LLC., has 30 years of experience working in complex, dynamic, safety critical systems supporting both government and commercial clients to address their toughest challenges, with efficient and low-risk solutions. Our collaborative work has improved the safety of transportation related human and systems infrastructure, increased the efficiency of the National Airspace System (NAS), and facilitated the modernization of both NAS and DoD systems and capabilities. Founded in 1990 and headquartered in Washington, D.C., CSSI employs nearly 200 employees throughout the country, helping customers across the United States and globally understand and implement the solutions to their biggest obstacles. For more information on CSSI, please visit www.cssiinc.com.

Posted 2 weeks ago

General Dynamics Ordnance and Tactical Systems logo
General Dynamics Ordnance and Tactical SystemsLincoln, NE
Overview General Dynamics Ordnance and Tactical Systems (GD-OTS) is looking for an experienced QA Sr. Technician - 3rd Shift to join our Lincoln, NE organization. We are expanding rapidly and looking for motivated and creative individuals who want to help support and shape this organization as we grow. GD-OTS provides reliable and affordable composite products to the defense and commercial aerospace markets. With more than 60 years of expertise, GD-OTS designs, develops, manufactures, and tests a full range of composite missile and space structures, including rocket motors, pressure vessels, launch tubes and fuel tanks. Position Location Detail: This position is located at our Main Plant facility. Internal Applications Close: . Major Position Responsibilities Defines and specifies activities, processes, and standards to fulfill the quality requirements for materials, components, or products. Builds and maintains the infrastructure and systems necessary to consistently ensure the timely delivery of quality products. Identifies and addresses any issues with equipment performance. Audits, monitors, and determines the quality of manufacturing processes and/or outputs against defined internal and regulatory standards. Reports and troubleshoots manufacturing process deviations and defects in finished goods Conducts tests on materials or samples to verify compliance with specifications and quality standards. Manager Specific Requests Perform in-process inspection of products with use of standard and specialized inspection equipment. ie micrometer, etc. Determines accept/reject decisions and document Nonconformances (NC's) accordingly. Ability to operate computer-controlled equipment and perform physical/mechanical tests utilizing known standards and specifications. Perform calculations to confirm compliance to geometric dimensioning and tolerancing schemes. Interpret drawings, prepares and maintains inspections records as required by established procedures. Basic Qualifications Vocational/Technical Training Degree and 3-5 years' experience OR Equivalent Combination of Relevant Education and/or Experience Manager Specific Requests Competent in operation of a CMM measurement system using PC-DMIS, Experience utilizing Brown and Sharp CMM is preferred but not required. Competent in GD&T (Geometric Dimensioning and Tolerances)

Posted 30+ days ago

Illinois Tool Works logo
Illinois Tool WorksHebron, IL

$18 - $23 / hour

Job Description: Duties & Responsibilities: Audit and monitor quality requirements in accordance with company quality assurance policies, documents, and customer specifications. Conduct inspections at First Article, In-Process, Incoming and completes Final Inspections per inspection plans. Perform routine visual/functional/dimensional testing per required specifications and procedures for the Quality and Assembly departments Identify nonconforming material and initiate nonconforming reports per established procedures. Communicate effectively with management, operators, process technicians and other inspectors about quality related concerns required. Utilize inspection tools such as calipers, micrometers, smart scope, scales, fixtures, gages, and microscopes to measure or inspect parts for compliance. Read and interpret blueprints and specifications, Process Flow Diagrams, Potential Failure Mode and Effects Analysis and Process Control Plans. Provide input on inspection methods related to continuous improvement initiatives related to the job. Conduct Layered Process Audits. Conduct Process Control Plan Audits Assist quality, engineering and production personnel with investigations of part defects or any quality related issues. Complete accurate and legible reports on the in-process inspection plans. Organize work and storage areas for efficient workflow. Perform basic mathematical operations and perform measured conversions. Understand and comply with the company's quality management system based on ISO 13485. Understand and comply with the company's environmental management system based on ISO 14001. Understand and comply with the company's safety policies and procedures. Perform additional duties to comply with departmental objectives as required Complete appropriate documentation, including release/hold paperwork/ databases Qualifications and Skills: High school diploma or equivalent 1 or more years of job-related experience Injection Molding experience (desired) Basic math skills to use scales and measure weights Basic knowledge of Microsoft Office Good verbal and written communication skills Ability to read and write English Attention to detail, organization, and strong multitasking abilities Ability to work in a team setting Excellent decision making and time management skills Ability to read and interpret blueprints and specifications Knowledge or ability to understand and use various test methods Commitment to continuous improvement Good Manufacturing practices To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, follow work instructions and job training requirements. Individual must be able to stand for full manufacturing shift, have ability to complete hand assembly process. Ability to reach with arms extended and/or overhead, excellent hand dexterity, ability to bend, stoop, stretch and similar activities and able to lift up to 35-50 pounds frequently. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. This job description should not be construed to contain every function/responsibility that may be required to be performed by an incumbent in this position. Incumbents are required to perform other related functions as assigned. Compensation Information: Pay Transparency This compensation range is provided as a reasonable estimate of the current salary range for this role. Compensation depends on relevant experience and/or education, specific skills, market level, other job-related factors, geographic location, and other factors as applicable by law. As applicable this role will also receive overtime compensation and may be eligible for shift premium compensation. Pay Range: $18.00 - $23.00 Benefits Benefits for this role can be seen by clicking on the following link: ITW Benefits for Life Your Way. In addition, employees can qualify for vacation, sick, and holiday compensation benefits. Vacation - up to 80 hours of time within first year Sick - up to 40 hours of time within first year Floating Holiday - up to 8 hours of time within first year Holiday - 10 paid holidays per year, these holidays are selected by the Division ITW is an equal opportunity employer. We value our colleagues' unique perspectives, experiences and ideas and create workplaces where everyone can develop their careers and perform to their full potential. As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship. All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws.

Posted 30+ days ago

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ADMA Biologics IncSouth Burlington, VT
Job Description Header: ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Specialist QA II Manufacturing Oversight in Boca Raton, FL! Job Title: Specialist QA II Manufacturing Oversight Job Description: Position Summary The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor. Essential Functions (ES) and Responsibilities Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}). Perform Quality Assurance review and approval of Deviation Reports. Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600. Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies. Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required. Review and release of Plasma pools to manufacturing. Review all manufacturing support documentation (logbooks, log sheets, charts, etc.) Review and release of raw materials in LIMS/SAP. Perform audits of Nitrogen receipt process. Perform notification and disposition of associated Lookback units. Assist with quarantining and release of critical systems, equipment, and controlled environments.\ Write, review, and revise QA SOPs. Review SOPs and documents from other departments and provide feedback as necessary. Work with other departments to assess if Deviations, CAPAs, and Change Controls are required. Assist with training of new employees. Coordinate and perform any additional activities or projects assigned by QA Management. Experience with LIMS and SAP preferred. Job Responsibilities or Job Requirements Competencies Exceptional organizational and communication skills required Must have excellent writing and oral skills Experience Requirements EDUCATION REQUIREMENTS: Bachelor's Degree preferred but can be offset by experience. EXPERIENCE REQUIREMENTS: 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry. Preferred Experience Compliance Requirements (ES) As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue. Job Description Footer: In addition to competitive compensation, we offer a comprehensive benefits package including: 401K plan with employer match and immediate vesting Medical, Vision, Life and Dental Insurance Pet Insurance Company paid STD and LTD Company Paid Holidays 3 Weeks' Paid Time Off (within the first year) Tuition Assistance (after the first year) Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. ADMA Biologics is an Equal Opportunity Employer. Apply now

Posted 30+ days ago

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American Regent LaboratoriesShirley, NY

$70,100 - $85,000 / year

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under supervision, assist with documentation for the closure of investigations. Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and 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. High School or GED diploma required. Associate's degree or equivalent years of experience preferred. Experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. PC Skills Required (MS Word, Excel). Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. Our recruiting process includes multiple in person and/or video interviews and assessments. If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

Posted 3 weeks ago

U logo
Umb Financial CorporationKansas City, MO

$83,200 - $178,800 / year

UMB Information Technology organization is comprised of IT leaders, project managers, architects, software engineers, and analysts coming from diverse background and experiences. We share a strong commitment to ensure our enterprise-level systems are performing at peak capacity and we believe in fully supporting each other to achieve this goal. As the QA Project Coordinator, you will serve as a key leadership liaison to the vendor QA team and coordinate the integration activities between UMB and the vendor partner. You will lead and delegate projects and project work to internal QA Analysts and the vendor QA teams. You will also assure key stakeholders are identified across the organization for assigned projects to facilitate appropriate interaction with the QA vendor partner. This is a subset of the overall responsibilities which involves other initiatives as assigned by IT leadership. This role is hybrid (Mon through Thu on-site / Fri remote) at the UMB Tech Center located in downtown Kansas City, MO. How you'll spend your time: Serve as leadership liaison to vendor QA team and manage the integration activities between UMB and the vendor partner. This includes serving as a strong liaison between testing teams, project managers, and stakeholders. Lead and delegate project work and testing activities to vendor QA team members. Ensure key issues and dependencies have ETA's from owning organizations and clarify owners for dependency items that need to be planned and closed. Work with vendor QA leads to ensure appropriate QA allocation and capacity. Understand status of testing activities and work with project managers, developers, and QA in communicating and updating status. This includes collaborating with project managers and development teams to determine the scope of the testing effort and testing resource requirement resulting in plans, schedules, and implementation of small to large scale testing projects. Participate in identifying testing roadmap items on overall project plan. Responsible for improving the quality of all software products through the development of testing standards, processes, test tools, test scripts, and test automation that will produce robust and reliable software in a timely manner. Analyze and provide input into the need for Load and Performance testing as well as Automated testing to stated requirements and company standards. Identifies testing requirements and scenarios and perform some manual testing. This includes creating and coordinating testing schedule for projects. We're excited to talk with you if you have: You have a Bachelor's Degree and at least 8 years of experience in Quality Assurance and software application testing (manual and automation) and testing management OR equivalent combination of education and work experience. You have experience in managing QA projects across methodologies. You have experience within Waterfall and Agile/Scrum methodologies. Bonus Points if: You have IT project management or business analysis experience. You have experience within the banking or payments industry. Applicants must have legal authority to work in the United States. Work Visa sponsorship is not available for this position. Compensation Range: $83,200.00 - $178,800.00 The posted compensation range on this listing represents UMB's standard for this role, but the actual compensation may vary by geographic location, experience level, and other job-related factors. In addition, this range does not encompass the full earning potential for this role. Please see the description of benefits included with this job posting for additional information UMB offers competitive and varied benefits to eligible associates, such as Paid Time Off; a 401(k) matching program; annual incentive pay; paid holidays; a comprehensive company sponsored benefit plan including medical, dental, vision, and other insurance coverage; health savings, flexible spending, and dependent care accounts; adoption assistance; an employee assistance program; fitness reimbursement; tuition reimbursement; an associate wellbeing program; an associate emergency fund; and various associate banking benefits. Benefit offerings and eligibility requirements vary. Are you ready to be part of something more? You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people who care about their work, one another, and their community. Expect more than the status quo. At UMB, you can expect more heart. You'll be valued for exactly who you are and encouraged to support causes you care about. Expect more trust. We want you to do the right thing, no matter what. And, expect more opportunities. UMBers are known for having multiple careers here and having their voices heard. UMB and its affiliates are committed to inclusion and diversity and provide employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including gender, pregnancy, sexual orientation, and gender identity), national origin, age, disability, military service, veteran status, genetic information, or any other status protected by applicable federal, state, or local law. If you need accommodation for any part of the employment process because of a disability, please send an e-mail to talentacquisition@umb.com to let us know the nature of your request. If you are a California resident, please visit our Privacy Notice for California Job Candidates to understand how we collect and use your personal information when you apply for employment with UMB.

Posted 30+ days ago

Osmo logo
OsmoElizabeth, NJ

$135,000 - $160,000 / year

Who we are at Osmo: Osmo is a digital olfaction company, on a mission to give computers a sense of smell to improve the health and wellbeing of human life. Why? Our sense of smell both enriches and saves lives, and has a deep and direct connection to our emotions and memory. Olfactory Intelligence has applications across industries including fragrance, manufacturing, security, medicine, and more. We believe in the power of automation and thoughtfully applied AI/ML to solve problems beyond the reach of human intuition alone. Osmo is headquartered in New York, NY, with a new facility in New Jersey, and offices in Somerville, MA. Osmo is seeking a QA Manager who will be responsible for overseeing all aspects of quality assurance within our fragrance manufacturing facility, ensuring that all products meet stringent internal and external quality standards, regulatory requirements, and customer expectations. This role will be pivotal in maintaining and enhancing our ISO9001 certified quality management system, implementing robust GMP (Good Manufacturing Practices) across all processes, and developing and enforcing effective sampling protocols. The ideal candidate will be a proven leader with solid quality control experienced in a manufacturing environment, preferably within the fragrance, flavors, cosmetics, or personal care industries. Key Responsibilities Quality Management System (QMS) Leadership: Maintain and continuously improve the company's ISO9001 certified Quality Management System. Develop, implement, and monitor quality policies, procedures, and standards in alignment with regulatory requirements and industry best practices. Lead internal and external audits, ensuring compliance and driving corrective and preventive actions (CAPAs). Manage document control and record-keeping systems for all quality-related activities. Quality Control Oversight: Oversee all quality control experienced activities, including incoming raw material inspection, in-process quality checks, and finished product testing. Develop and implement robust sampling protocols for raw materials, bulk products, and finished goods to ensure representative and accurate testing. Manage and optimize laboratory operations, including equipment calibration, method validation, and data analysis. Investigate and resolve quality issues, customer complaints, and non-conforming products, implementing effective root cause analysis and corrective actions. Team Leadership & Development: Lead and develop a QA program, which fosters a culture of quality, accountability, and continuous improvement. Provide guidance and support to production teams on quality-related matters. Conduct performance reviews and identify training needs for direct reports. Supplier Quality Management: Collaborate with procurement to establish and maintain supplier quality agreements. Conduct supplier audits and evaluations to ensure the quality of incoming materials. Continuous Improvement: Identify opportunities for process improvement and efficiency gains within the quality department and across manufacturing operations. Utilize quality metrics and data analysis to drive data-driven decision-making. GMP Implementation and Compliance: Ensure strict adherence to GMP principles throughout all stages of fragrance manufacturing, including raw material receiving, compounding, filling, packaging, and warehousing. Develop and deliver comprehensive GMP training programs for all relevant personnel. Conduct regular GMP audits and inspections to identify and address potential non-conformances. Required Qualifications Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or a related scientific field. Minimum of 5 years of progressive quality control experienced in a manufacturing environment, with at least 3-5 years in a QA Manager or similar leadership role. Demonstrated expertise in implementing and maintaining ISO9001 certified quality management systems. In-depth knowledge of GMP regulations and guidelines within the cosmetic, personal care, or pharmaceutical industries. Proven experience in developing and implementing effective sampling protocols. Strong understanding of analytical testing methodologies and laboratory operations relevant to fragrance manufacturing. Excellent leadership, communication, and interpersonal skills. Strong problem-solving and decision-making abilities. Ways to stand out Proficiency in quality management software and statistical analysis tools is a plus. Salary Range: 135K - 160K annually Benefits: Medical, Dental, Vision, 401K, and more. If this role inspires you we'd encourage you to apply. We are committed to recruiting, developing, and retaining an incredible team optimized for a diversity of thought, background, and approaches. Base salary is just one component of Osmo's total rewards package, which is designed to support the well-being, growth, and long-term success of our team members. Our comprehensive package includes health, dental, and vision coverage; a 401(k) retirement savings plan with company match; flexible paid time off and company holidays; and equity or incentive compensation for eligible roles. Actual compensation will vary based on factors such as experience, skills, location, internal equity, and other relevant business considerations. Osmo regularly reviews pay ranges to ensure they remain competitive, equitable, and aligned with current market data. All employment decisions and responsibilities are determined based on current ability and your ability to grow, without regard to race, color, gender identity, sex, sexual orientation, religion, age, marital status, physical, mental, or sensory disability, or any other characteristic protected by applicable law. Recruitment & Staffing Agencies: Osmo does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Osmo or its employees is strictly prohibited unless contacted directly by the Osmo Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Osmo and Osmo will not owe any referral or other fees with respect thereto. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire

Posted 30+ days ago

FIGMA logo
FIGMASan Francisco, CA
We're looking for an Integration Engineer, QA to join our Business Systems team. In this role, you'll focus on ensuring the reliability, accuracy, and compliance of integrations that connect our core business systems, including NetSuite, Salesforce, Workday, and Snowflake. You'll own QA strategy and automation for critical financial workflows such as Quote-to-Cash (Q2C), Month-End Close (MEC), and Quarter-End Close (QEC), driving end-to-end testing coverage for the systems that power Figma's revenue and accounting operations. This is a full time role that can be held from one of our US hubs or remotely in the United States. What you'll do at Figma: Own quality assurance for financial workflows across Salesforce, NetSuite, Workday, and other enterprise systems-defining, executing, and maintaining test plans for Q2C, MEC, and QEC processes Design and implement automated testing frameworks and regression cycles to validate data synchronization, transformations, and mappings across systems Collaborate with Integration Engineers to test APIs, webhooks, and automation pipelines that support financial and operational processes Partner with Finance Systems, Revenue Operations, and Sales Operations teams to define acceptance criteria, ensure functional coverage, and maintain data integrity across systems Ensure compliance and audit readiness by maintaining structured QA documentation aligned with SOX, SOC2, and ITGC requirements Develop and drive continuous testing practices to support release validation and change management processes Identify opportunities for process improvement, automation, and enhanced visibility across integration workflows Contribute to building QA best practices that scale with Figma's financial systems as the company continues to grow globally We'd love to hear from you if you have: 5+ years of QA or systems testing experience in enterprise environments, ideally within Finance or Business Technology teams Hands-on experience testing Salesforce, NetSuite, Workday, or comparable ERP/CRM systems Deep understanding of financial workflows, including quote-to-cash, revenue recognition, and financial close cycles Experience testing API-based integrations and validating data pipelines across systems Familiarity with SOX and ITGC compliance frameworks, with a proven ability to maintain documentation and audit evidence Strong analytical, documentation, and communication skills-particularly when working with cross-functional business and engineering teams While not required, it's an added plus if you also have: Experience with test automation tools such as Cypress, Postman, or pytest Experience with SQL or scripting experience for data comparison and reconciliation testing Familiarity with Salesforce API automation (REST, Bulk, or Composite APIs; Platform Events) or continuous testing frameworks Exposure to AI-assisted QA, intelligent monitoring tools, or data-driven automation practices At Figma, one of our values is Grow as you go. We believe in hiring smart, curious people who are excited to learn and develop their skills. If you're excited about this role but your past experience doesn't align perfectly with the points outlined in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

Posted 3 weeks ago

Proofpoint Inc logo
Proofpoint IncPittsburgh, PA

$120,525 - $237,050 / year

About Us: Proofpoint is a global leader in human- and agent-centric cybersecurity. We protect how people, data, and AI agents connect across email, cloud, and collaboration tools. Over 80 of the Fortune 100, 10,000 large enterprises, and millions of smaller organizations trust Proofpoint to stop threats, prevent data loss, and build resilience across their people and AI workflows. Our mission is simple: safeguard the digital world and empower people to work securely and confidently. Join us in our pursuit to defend data and protect people. How We Work: At Proofpoint you'll be part of a global team that breaks barriers to redefine cybersecurity guided by our BRAVE core values: Bold in how we dream and innovate Responsive to feedback, challenges and opportunities Accountable for results and best in class outcomes Visionary in future focused problem-solving Exceptional in execution and impact Corporate Overview Proofpoint is a leading cybersecurity company protecting organizations' greatest assets and biggest risks: vulnerabilities in people. With an integrated suite of cloud-based solutions, Proofpoint helps companies around the world stop targeted threats, safeguard their data, and make their users more resilient against cyber-attacks. Leading organizations of all sizes, including more than half of the Fortune 1000, rely on Proofpoint for people-centric security and compliance solutions mitigating their most critical risks across email, the cloud, social media, and the web. We are singularly devoted to helping our customers protect their greatest assets and biggest security risk: their people. That's why we're a leader in next-generation cybersecurity. Protection Starts with People. Proofpoint's ZenGuide team is looking for Sr. QA Automation Engineer. The candidate will test all aspects of our various ZenGuide products. Candidates must be able to create, maintain and expand the existing automated regression suites to support ongoing Product Development for software releases. Additionally, they must be able to devise test cases from requirements, perform exploratory testing and write and execute automated regression tests. They must be able to work effectively within Agile teams, with developers and product owners, to decompose user stories/requirements and write automated tests at the Business logic, Contract, and User Interface levels. They must be able to handle multiple assignments and tasks simultaneously. They must be able to estimate the time and resources required for testing and demonstrate a proven ability to complete software testing effectively within the established schedules. Our Engineers are designing and developing our market-leading security training and assessment software. Our goal is to help organizations teach their employees to secure behavior through interactive web applications, received and managed by our customers on our proprietary SaaS platform. The ideal candidate is enthusiastic to work with cutting-edge technologies in a fast-paced environment supporting a global SaaS product. As a QA Automation Engineer you will lend your skill sets to help lead the testing of a key customer-facing component that has high visibility and value within the organization. Your day to day Analyze product requirements and develop test plans and test cases Design and develop test automation scenarios to validate system interfaces and system integrations Collaborate with developers to allocate testing between automated back-end, integration, and UI tests Perform manual exploratory testing on new requirements, prior to writing automated integration tests, and maintaining them as regression tests Work with developers to build quality in, and make sure new software goes out with the proper automated tests coverage Evaluate unit test coverage to determine QA automation tests on new and current features Identify and implement complex automation efforts, including refactoring of automation code where needed Provide automation tests for Ops team to use in CICD quality gates Utilize system tools to diagnose and fully document test failures, identifying the source of the failure and providing steps to reproduce Review and reproduce product defects that are reported by customers before corrections are delivered for testing Review and validate tests written by Developers and other QA members Coordinate the testing done by others or assist in that coordination Continuously identify process improvement opportunities Provide technical support and mentoring to junior team members Participate in Agile sprint planning, stand-ups, and retrospective meetings What you bring to the team Two or more years of experience in Software QA and Test Automation BS in Computer Sciences or Information Technology, or equivalent experience Must have strong Java skills, or very good skills and experience in another object-oriented language Experienced in advanced code development, code review, and construction of automation frameworks We are moving towards automated testing in an EKS/Docker environment and experience with these technologies is a plus Experience collaborating with teams during the design and implementation phases to develop the best test approach incorporating the appropriate level of testing while understanding test coverage Comprehensive knowledge of modern browsers, operating systems, and user interface testing techniques Demonstrated ability to develop new technical skills; our technologies are moving at a rapid pace and you will need to move with them Maintaining automated tests means debugging when they fail.You must be able to learn and understand the product architecture, and the test architecture Strong interpersonal skills and demonstrated experience working as part of a technical team Strong understanding of unit, integration, and API testing. Playwright is a plus Comprehensive knowledge of Microsoft Azure, Server platform, and email security Test Lead experience is a plus Excellent time management skills and strong attention to detail Why Proofpoint As a customer focused and driven-to-win organization with leading edge products, there are many exciting reasons to join the Proofpoint team. We believe in hiring the best the brightest and cultivating a culture of collaboration and appreciation. As we continue to grow and expand globally, we understand that hiring the right people and developing great teams is key to our success! We are a multi-national company with locations in many countries, with each location contributing to Proofpoint's amazing culture! #LI-AN1 Why Proofpoint? At Proofpoint, we believe that an exceptional career experience includes a comprehensive compensation and benefits package. Here are just a few reasons you'll love working with us: Competitive compensation Comprehensive benefits Career success on your terms Flexible work environment Annual wellness and community outreach days Always on recognition for your contributions Global collaboration and networking opportunities Our Culture: Our culture is rooted in values that inspire belonging, empower purpose and drive success-every day, for everyone. We encourage applications from individuals of all backgrounds, experiences, and perspectives. If you need accommodation during the application or interview process, please reach out to accessibility@proofpoint.com. How to Apply Interested? Submit your application along with any supporting information- we can't wait to hear from you! Consistent with Proofpoint values and applicable law, we provide the following information to promote pay transparency and equity. Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets as set out below. Pay within these ranges varies and depends on job-related knowledge, skills, and experience. The actual offer will be based on the individual candidate. The range provided may represent a candidate range and may not reflect the full range for an individual tenured employee. This role may be eligible for variable compensation and/or equity. We offer a competitive benefits package, including flexible time off, a comprehensive well-being program with two paid Wellbeing Days and two paid Volunteer Days per year, plus a three-week Work from Anywhere option. Base Pay Ranges: SF Bay Area, New York City Metro Area: Base Pay Range: 161,625.00 - 237,050.00 USD California (excludes SF Bay Area), Colorado, Connecticut, Illinois, Washington DC Metro, Maryland, Massachusetts, New Jersey, Texas, Washington, Virginia, and Alaska: Base Pay Range: 132,225.00 - 193,930.00 USD All other cities and states excluding those listed above: Base Pay Range: 120,525.00 - 176,770.00 USD

Posted 2 weeks ago

S logo
Silicon Laboratories Inc.Boston, MA

$118,650 - $220,350 / year

Silicon Labs (NASDAQ: SLAB) is the leading innovator in low-power wireless connectivity, building embedded technology that connects devices and improves lives. Merging cutting-edge technology into the world's most highly integrated SoCs, Silicon Labs provides device makers the solutions, support, and ecosystems needed to create advanced edge connectivity applications. Headquartered in Austin, Texas, Silicon Labs has operations in over 16 countries and is the trusted partner for innovative solutions in the smart home, industrial IoT, and smart cities markets. Learn more at www.silabs.com. Senior QA Software Engineer Boston, MA Our Boston office host various teams belonging to the IoT software division, including Platform, wireless tools and protocols, quality assurance, application specialists, and project management teams. We are proud of the work atmosphere we maintain by fostering excellent collaboration and good communication at all times. Meet the Team The IOT Software Quality Assurance (SQA) Team at Silicon Labs, which is spread across several different geographical locations, focuses on improving the overall quality of the Silicon Labs SiSDK Product. The SiSDK products contain all the wireless (Bluetooth Low Energy (BLE), Bluetooth Mesh, Zigbee, OpenThread, Matter, Wi-Sun, Z-Wave, and proprietary protocols) and 32 bit micro-controller (MCU) software required to build end products for the Internet of Things (IoT) Market. Silicon Lab's SQA Team works closely with the Software (SW) Development teams to ensure a deep understanding of the product, features and system functionality. Silicon Lab's SQA Team utilizes an internal test framework to automate all tests for repeatability and stability along with providing detailed test reports on each build of the product to provide our customers with quality assurance. The SQA team has decades of experience in providing high quality embedded SW products to our customers which include the largest names in the industry. Responsibilities Design and execute functional, negative, performance, and stress tests for Silicon Lab's embedded wireless and MCU products. Work closely with development team(s) to debug problems found during the test cycle Develop automation tests so they can be run regularly as part of a continuous integration infrastructure Assist in resolving customer issues by working closely with the customer support team to answer and reproduce customer-related issues Emulate customer environments by working closely with the sales team and field application engineers in supporting customer's needs and debug customer's problems Build, manage, and maintain a distributed test network Simplification and automation of product deployments and platform changes Productivity increase of the team through identifying opportunities to automate and script daily tasks and eliminate waste in existing processes Skills You Will Need Minimum Qualifications: Minimum of Bachelor of Science in Electrical Engineering or Computer Science with 5+ years industry experience as a software developer and/or test automation Knowledge of Python/Pytest in addition to C/C++ with GenAI Knowledge of Jenkins for CI, Docker and GIT as Source control are a must. Data communications and networking experience (TCP/IP, etc) Wireless protocols knowledge. Experience with continuous integration technique and test automation system. Able to create and review test plans based on requirements. Ability to plan CI processes. Experience in implementing test strategies and test plans. The following qualifications are considered a plus: Experience with continuous integration WiFi and Thread protocols knowledge Test Application development including standard API's (REST API) Experience with task management and bug tracking systems such as JIRA Team leading and-or coordinating experience IoT Domain knowledge Benefits & Perks You can look forward to the following benefits: Great medical (Choice of PPO or Consumer Driven Health Plan with HSA), dental and vision plans Highly competitive salary 401k plan with match and Roth plan option Equity rewards (RSUs) Employee Stock Purchase Plan (ESPP) Life/AD&D and disability coverage Flexible spending accounts Adoption assistance Back-Up childcare Additional benefit options (Commuter benefits, Legal benefits, Pet insurance) Flexible PTO schedule 3 paid volunteer days per year Charitable contribution match Tuition reimbursement Free downtown parking 2 weeks a month Onsite Gym and locker rooms coming in April 2026 Monthly wellness offerings Free snacks Monthly company updates with our CEO #LI-KB1 #LI-Hybrid The annualized base pay range for this role is expected to be between $118,650 - $220,350 USD. Actual base pay could vary based on factors including but not limited to experience, geographic location where work will be performed and applicant's skill set. The base pay is just one component of the total compensation package for employees. Other rewards may include an annual cash bonus, equity package and a comprehensive benefits package. Silicon Labs is an equal opportunity employer and values the diversity of our employees. Employment decisions are made on the basis of qualifications and job-related criteria without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristic protected by applicable law.

Posted 30+ days ago

Smithfield Foods, Inc. logo
Smithfield Foods, Inc.Des Moines, IA
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! THE VALUE YOU'LL BRING: The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section. As part of our Food Safety & Quality Assurance team, you will ensure our products meet the highest safety and quality standards. You will conduct sanitation checks, enforce HAACP and USDA regulations, and track products from start to finish, implementing corrective actions as needed. Overseeing FSQA programs in specific production areas, you will ensure compliance, train employees, and drive continuous improvement. With opportunities to step into FSQA Manager duties, you will play a vital role in delivering safe, high-quality products under brands like Smithfield, Eckrich, and Nathan's Famous. If you are passionate about food safety, quality and leadership, join us and make an impact! WHAT YOU'LL DO: The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Food Safety & Quality Assurance Leadership- You'll ensure that all Food Safety, Quality Assurance, SQF, and Regulatory programs are executed and documented accurately, maintaining compliance and product integrity. Your role will involve investigating and resolving product/process failures quickly, minimizing downtime, and ensuring safety and quality standards are consistently met. You will collaborate closely with plant management, production teams, and the USDA to drive continuous improvement in food safety, quality, and sanitation. Continuous Improvement & Compliance- You'll prevent failures by actively managing HACCP, SSOP, and product specifications. Leading efforts to improve product quality and processes in partnership with FSQA staff and Operations will be a key responsibility. Additionally, you will oversee and participate in plant committees and task forces, such as the Health and Safety Committee, to enhance safety and quality standards. Sanitation & SQF System Ownership- You will conduct operational and pre-operational sanitation inspections and micro sampling to ensure the effectiveness of sanitation practices. As the owner of the SQF system, you'll maintain and reassess the SQF Plan regularly, ensuring it remains compliant and up to date. You will also communicate key updates and ensure team-wide awareness for the effective implementation of the SQF system. Team Development- You'll manage the work assignments, training, and development of food safety and quality assurance staff, fostering a high-performance team that upholds the highest standards of food safety and quality. WHAT WE'RE SEEKING: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Bachelor's degree from an accredited four-year college or university and 2+ years' relevant experience in food safety or quality assurance; or equivalent combination of education and experience. Experience acting as a lead by providing training, coaching or mentoring to less experienced staff or through managing a process or project. Familiarity with meat processing, USDA, HACCP, SSOP, and SQF Ability to uphold regulatory, company, and customer standards and address inquiries or complaints. OTHER SKILLS THAT MAKE YOU STAND OUT: HACCP and SQF certifications preferred. Ability to uphold regulatory, company, and customer standards and address inquiries or complaints. Proficiency in database, inventory, manufacturing software, QMS systems, SAP, and MS Office. Strong written and oral communication, with excellent decision-making and problem-solving abilities. Strong planning, multitasking, and project management skills. Must complete forms in English; ability to travel up to 20% and work extended hours or weekends as needed. Ability to work effectively in a fast-paced environment, fostering positive relationships and a team-oriented atmosphere. PHYSICAL DEMANDS & WORK ENVIRONMENT: The physical demands described here are representative of those an employee should possess to successfully perform the essential functions of this job. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Occasionally lift and/or move up to 50 pounds Specific vision includes close vision, distance vision, and ability to adjust focus. Additionally ability to differentiate colors. Frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. Noise level in the work environment is usually moderate but can be loud when in the production area. IndSPR-Ops Relocation Package Available Yes EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 1 week ago

W logo
Windward IT SolutionsFairfax, VA
Windward Consulting is at the forefront of Service-Centric IT. With strategic consulting, unparalleled technical expertise and our proven Windward Service-Centric IT RoadMap, we help our clients align the core competencies of process, organization, information and technology to run the most sensitive and mission-critical IT environments in the world. If you are looking for an opportunity to be involved with a team of individuals who are working for one of our cutting-edge clients solving complex technical challenges, then we are looking for you. We are looking for people who are passionate about technology and have a "roll up their sleeves mentality." Here at Windward we offer numerous opportunities to expand your experience in various areas depending upon your aptitude and interests. Our employees are not only passionate and driven but strive to ensure customer quality is delivered consistently and effectively. Position Summary The Sponsor requires contractual support to perform business analyst functions, with some development and O&M activities for the Business Management Database (BMD) application. Job Description The Sponsor provides business operations support to identify, collect, store, and visualize business information needed for enterprise decision-making. The Contractor Team supports BMD by performing development and O&M, maintaining integrations, and enhancing system capabilities. Responsibilities include: Stakeholder coordination to solicit requirements or details for existing requirement requests, analyze said input and decompose into actual development stories/tasks (BA Role) Performing O&M activities and implementing development updates driven by changing Sponsor requirements and system changes. Testing new feature development, fixes, and updates to application infrastructure (VMIs, java versions, etc) Architecture of development solution to meet large requirements Maintaining system documentation, SOPs, guides, and FAQs. Streamlining workflow processes for an employee dashboard covering order management requirements. Ensuring adherence to security and data protection requirements. Supporting application development and system administration within an AWS multi-zone cloud environment. Managing and resolving infrastructure issues affecting performance or availability. Developing an API between BMD and ServiceNow (bi-directional flow of requirement numbers/statuses and other custom API needs). Maintaining AWS Cloud assets, executing build processes, and ingesting Sponsor design/development requirements. Location and Qualification Requirements Work to be performed on-site in Fairfax, VA Requires active DoD TS/SCI Clearance Skillset Requirements Mandatory Agile methodology DevOps practices (sprint planning, CI, testing) User acceptance testing Delivery of minimum viable increments Visualization/reporting tools (e.g., Tableau) Java development Full-stack experience across UI, business logic, and database layers AWS experience (SWF, Data Pipeline, RDS, CloudWatch, EC2, EBS, S3) AWS services (EC2, KMS, patching) Linux administration Data ETL or Perl scripting Apache HTTPD, Linux Shell, or PowerShell scripting DevOps tools (GitHub, Subversion, Jenkins, CruiseControl, Maven, Artifactory, Confluence) Desired Networking Technology knowledge, as well as network design concepts Familiarity with enterprise billing systems and accounting principles ServiceNow experience AngularJS experience Sponsor security requirements and data protection AWS and additional security tools Project management principles Integration with customer applications via web services Sponsor security/accreditation processes Windward strives to attract and retain the best individuals and provide an environment where they can all grow professionally and build a rewarding career. We continually strive to create an environment that balances work life and offers benefits that will enhance the compensation package. We offer Medical, Dental, Vision, Flexible Spending Accounts, Short Term Disability, Long Term Disability, Life Insurance and AD&D, as well as the option to purchase additional Life Insurance and AD&D, Paid Time Off, Personal Leave, Holidays, 401(k) plan with company match and work/life balance. Windward IT Solutions is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.

Posted 4 days ago

I logo

Incog Biopharma Services Careers - QA Specialist For IQC

INCOG BioPharmaFishers, IN

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Job Description

Quality Assurance Specialist, IQC Summary

Working closely with the QA Operations Supervisor and IQC Supervisor. QA Specialist will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Specialist, IQC will need to provide support with identifying operational and quality gaps.

The Quality Assurance Specialist, IQC will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Specialist, IQC will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Specialist, IQC will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

Essential Job Functions:

  • Maintain a Quality Assurance presence and provide verification of incoming pharmaceutical shipments and contents against purchase orders, materials specifications and receiving in line with INCOG SOP's. Review and approve documentation, including but not limited to logbooks, material packets, material specifications, packing lists, work orders, procedures, etc.
  • Collaborate with Supply Chain, IQC, and Operations team and lead or provide support with investigations to resolve inventory and material, consumables, and component related deviations.
  • Support other QA personnel from Operations as necessary with batch record reviews, corrections, floor operations, etc.
  • Inspect products for damage, discrepancies, or expired items and report any issues to the Warehouse Manager.
  • Prioritize and coordinate his/her time in balancing timelines with product quality assurances.
  • Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
  • Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
  • Provide Quality Assurance oversight into the picking of product Bill of Materials (BOM).
  • Assist Supply Chain Management with Critical Alarm reporting with freezer farm or incubator alarms.
  • Perform both provisional and full release of materials.
  • Dispose of Filled Inspected Product (FIP) rejects following batch disposition.
  • Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
  • Assist Operations with incoming and outgoing Material Transfer counts.
  • Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
  • Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
  • Provide Quality Assurance oversight with Supply Chain inventory cycle counts and investigate any discrepancy.
  • Ability to manage multiple projects in a fast-paced environment.
  • Assist in maintaining records for regulatory inspections and audits.

Special Job Requirements:

  • This position will support primarily first shift (7:00 am - 3:30 pm) with occasional weekend support, dependent on operations' needs.
  • Bachelor's Degree required or equivalent; degree preferred to be in Logistics, Supply Chain, Management, Biology or Chemistry
  • Minimum of 4 years with experience working as Quality in a GMP Manufacturing environment, Raw Material/ Component/Consumable release and/or as an Operator within a Pharmaceutical Supply Chain/Warehouse environment.
  • Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..
  • Understanding of Good Documentation Practices (GDPs) and its criticality.
  • Ability to obtain Powered Industrial Lift Certification.
  • Excellent written and verbal communication skills.
  • Ability to lift 50 lbs.
  • General computer skills evidenced by hands-on work with inventory management systems; and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Additional Preferences:

  • Hands-on experience with aseptic manufacturing, inspecting finished products, and supply chain or warehousing.
  • Experience with Continuous improvement, Six Sigma, and/or Lean principles.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

By submitting your resume and details, you are declaring that the information is correct and accurate.

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