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Construction QA Supervisor (On-site) - Phoenix, Arizona-logo
Construction QA Supervisor (On-site) - Phoenix, Arizona
Decima InternationalPhoenix, Arizona
Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula: Approach each client engagement as a partnership , create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards. DESCRIPTION Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula: Approach each client engagement as a partnership , create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards. If you are interested in a long and rewarding career working with high-profile clients on some of the most challenging projects in the world, then Decima is where you belong. At Decima, you will be able to explore incredible growth and professional development opportunities. We are looking for a driven and capable Civil Structure Architecture QA Supervisor to support us with the development of multiple data center projects for one of the top technology clients in the world. This is a client-facing role that requires strong interpersonal, communication, and organizational skills, the ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently and across multiple regions. A strong background in data center development, design, engineering, controls, and operations requirements is a big plus. You will play an integral role in ensuring the implementation and management of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction inspection and testing services of a project. The Civil Structure Architecture QA Supervisor is accountable for the guarantee of the work performed, as well as meeting the project’s contractual requirements set forth by the client. We are looking to bring in dedicated individuals with a passion for innovation and talent for multitasking in a fast-paced environment. We will help you grow, pursue, and fulfill what inspires you so we can make big impacts on the world, together. RESPONSIBILITIES Develop a sound knowledge of the project scope and requirements. Ensure compliance with stringent contract and owner quality requirements. Prepare comprehensive, project-specific QC plans. Review and verify material submittals for A/E and Client review. Verify delivered materials comply with approved submittals. Provide and review submittals, RFI logs, maintenance logs, and other project-related materials in a timely manner. Review and update QC punch lists and coordinate punch list completion with GC and subcontractors. Verify the implementation and operation of the quality assurance and control systems by planning and conducting internal quality audits and inspections of activities on site. Ensure implementation and continuous improvement in overall Quality Systems. Ensure that all contractual / company and local authority requirements for Quality, Health, Safety & Environment (HSE) requirements are complied with. Review, update, and verify the distribution of the Quality Management Procedure, Quality Manual, and related procedures for Infrastructure, MEP, Civil, and other subcontractors and divisions by the GC. Verify that GC implements adequate training/awareness of company personnel for Quality systems. Ensure that all non-conformance issues are promptly investigated, corrective and preventive actions are proposed/implemented, and are quickly closed out. Ensure that the contractual quality requirements of a project are fully communicated to all key personnel, so that their roles in fulfilling these requirements are fully understood. Ensure that all GC and subcontractors' quality systems and plans are acceptable to the company as applicable to the "Project Contract". Ensure that Subcontractors'/Suppliers' quality systems are implemented and effective. Ensure that the calibration of all inspection, measurement, and test equipment is conducted according to the defined schedule. Conduct reviews of the approved suppliers and subcontractors' list. Liaise with the General Contractor, Client, and Project Management team to ensure that all potential and actual quality issues are fully resolved. Establish a strong relationship with the GC and Client, and communicate with both technical and management-level personnel. Prepare PowerPoint decks and present to management on progress, findings, and recommendations. Review project plans, requirements, and specifications. Perform other related duties as required and assigned. QUALIFICATIONS Required Qualifications : 15+ years of construction quality management experience. Bachelor's degree in Civil, Structural, Architectural Engineering, or a related field. Experience with managing field engineering, inspection, and NDE related to all QA/QC functions. Ability to develop and manage non-conformance, deficiencies, and reporting programs, including root cause analysis. Experience in developing and monitoring project QA/QC budgets. Ability to ensure that correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded. Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor. Experience working as a QA/QC Manager for large Commercial, Industrial, or Mission-Critical Facilities construction projects. An excellent understanding of construction Quality Management Systems (QMS). Experience developing various types of reports, targeting different audiences. Experience in client-facing positions. Demonstrated ability to understand technical and complicated construction programs and the ability to communicate progress to both technical and management-level personnel. Strong communication skills, including the ability to communicate with any audience clearly and accurately. Proficient in Microsoft Office programs. Preferred Qualifications: Project Management Professional (PMP) certification. Certified Construction Manager (CCM) certification. Strong background in data center development and construction. POSITION DETAILS: Primary Location (On-site): Phoenix, Arizona Position: CSA QA Supervisor Position Classification: Salary-based full-time regular hours Current US work permit required. This position does not offer sponsorship for employment (e.g., H-1B visa sponsorship or transfer not offered) PRODUCTIVITY TOOLS: ​ Microsoft Office Microsoft 365 Job Type: Full-time Schedule: 8-hour shift Work Location: (On-site) Phoenix, Arizona Decima International is an Equal Opportunity Employer who is committed to the safety and wellbeing of all. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. At Decima International, we offer a competitive salary package, including paid time off and performance-based bonuses. We also provide excellent medical, vision and dental insurance for our employees.

Posted 2 days ago

Web QA Engineer-logo
Web QA Engineer
GeneracReno, Nevada
We are Generac, a leading energy technology company committed to powering a smarter world. Over the 60 plus years of Generac’s history, we’ve been dedicated to energy innovation. From creating the home standby generator market category, to our current evolution into an energy technology solutions company, we continue to push new boundaries. Primary Purpose As a Web QA Engineer, you will work closely with Product Stakeholders, UX Designers, Developers, and fellow QA Engineers in an Agile, cross-functional environment. You'll gain hands-on experience with cutting-edge tools, gadgets, frameworks, and technologies, while shaping the future of IoT. Major Responsibilities / Job Duties Advocate for quality throughout the development process. Perform comprehensive testing to verify, validate, and reduce risk, ensuring the delivery of top-quality products. Automate tests, contributing to building scalable, reliable systems. Provide valuable insights from planning through deployment, ensuring testing is integrated early in the process. Engage in a variety of challenges, whether it's testing monolithic applications, microservices, or creating and executing unit, integration, and end-to-end tests for applications. Minimum Job Requirements / Job Duties Education: Bachelor’s degree Work Experience: 2 years of experience in QA Knowledge / Skills / Abilities We've built the following list as a guideline for some of the skills and interests we've seen in QA Engineers - but we strive to build our team with members from a diverse background and skill set, so if any combination of these apply to you, we’d love to chat! A critical thinker with a passion for quality and software testing. Curiosity and resourcefulness that help you identify problems and devise creative solutions. Extensive experience with software testing techniques, methodologies, and tools. Strong representation of the QA team in cross-functional meetings, advocating for quality at every decision-making stage. A hands-on tinkerer who loves creating apps and robots in your spare time. Enjoyment of collaborative work in an agile, fast-paced development environment. Diligence in documenting test plans, cases, bug reports, and research findings. Experience writing test automation scripts using Playwright and Java Comfort with testing web, APIs, integration, exploratory, performance/load/stress, usability, accessibility, and security. Familiarity with CI/CD pipelines, using tools like Jenkins, CircleCI, or similar. Physical Demands : While performing the duties of this job, the employee is regularly required to talk and hear; and use hands to manipulate objects or controls. The employee is regularly required to stand and walk. On occasion the incumbent may be required to stoop, bend or reach above the shoulders. The employee must occasionally lift up to 25 - 50 pounds. Specific conditions of this job are typical of frequent and continuous computer-based work requiring periods of sitting, close vision and ability to adjust focus. Occasional travel. “We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.”

Posted 2 days ago

QA/QC Aircraft Inspector - Up to $25K Hiring Bonus / Relocation Incentive DOE-logo
QA/QC Aircraft Inspector - Up to $25K Hiring Bonus / Relocation Incentive DOE
Western AircraftBoise, Idaho
Job Summary Perform in-progress and final inspections on articles under assembly, repair, and/or alteration. Ensure all maintenance performed is in accordance with FAA regulations, the RSM (Repair Station Manual), and the OEM (original Equipment Manufacturer) maintenance manuals for approval of any article for Return to Service (RTS). This will be accomplished by physical inspection and paperwork review. SCHEDULE Monday-Friday 7am-4pm (minimum 40 hours per week) SIGN-ON BONUS Up to $25,000 sign-on bonus / relocation incentive available depending on experience. Duties & Responsibilities Perform visual inspections for quality and workmanship Monitor service department adherence to the Western Safety Manual Service is performed IAW the Repair Station Manual and FAA regulations Ensure that Western Aircraft Policy and Procedures are followed Make decisions to determine airworthiness Determine part approvals Determine major/minor repair or alterations Ensure Certificated 135 Operator’s AAIP or CAMP programs are adhered to during maintenance Ensure proper tooling is used to determine airworthiness and is currently calibrated when applicable Communicate with the leads and the assigned Service Managers regarding assigned work orders Ensure all maintenance performed is of such quality that the condition of the aircraft, airframe, engine, propeller or appliance worked or will be at least equal to its original or properly altered condition RTS Authority Technician duties may be required at times Qualifications & Job Requirements Minimum five (5) years’ experience in general aviation maintenance required Airframe & Powerplant Certifications required Previous QA/QC Aircraft Inspector experience preferred Experience with Gulfstream, Dassault Falcon, King Air, Cessna, Piper and Pilatus preferred Strong knowledge of FARs Strong proficiency with MS Word and Excel Other Prerequisites Pass pre-employment drug screen and background check Ability to obtain Airport Issued security badge Work Environment & Physical Requirements Work is primarily performed in an aircraft hangar environment with moderate noise level, inside environmental conditions, which provide protection from weather conditions but not necessarily from temperature changes. Working around equipment with moving parts, ability to lift and carry 50 pounds, frequent standing sitting, walking balancing and stooping. Available Benefits Medical, dental, vision Short term & Long term Disability - paid 100% by Company Life & Accidental Death and Dismemberment - paid 100% by Company Paid vacation, holidays, sick leave, jury duty, bereavement Health Savings Account or Health Reimbursement Account (employer contributions tied to participation in wellness program) 401K & Roth 401k with employer match Flexible Spending programs Western Aircraft Inc. has a Drug Free Workplace Policy which includes applicants passing pre-employment testing in accordance with 14 CFR 120. Applicants testing positive for the presence of prohibited drugs are ineligible for employment. DOT applicants who become employees of Western Aircraft Inc. will also be subject to random, reasonable cause, reasonable suspicion, and post-accident testing. Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Posted 1 week ago

QA Tech 1 - 1st Shift-logo
QA Tech 1 - 1st Shift
ExternalIrwindale, California
Title: QA Tech I -1 st shift Department: Quality Location: Irwindale, CA Shift: 1st shift Pay rate: $20.50 an hour Reports to: QA Lead Position Summary: The QA Tech 1 is a key Quality Assurance role within the plant and supports QA team leads in safeguarding compliance with food safety and quality requirements. As a QA Tech 1 at Bonduelle Fresh Americas (“BFA”), you will embrace our vision of Giving People the Freedom to Eat HealthierTM through excellence and daily performance of essential quality assurance functions, including finished goods checks and sampling for PCT testing (Hold & Release products). What if your job had a real impact? By joining Bonduelle, the world leader in ready-to-use plant-based food, you are deciding to make a positive and sustainable impact on yourself, others and the planet. You will play an active part in our mission: "inspire the transition toward a plant-based diet to contribute to people's well being and planet health". Bonduelle is a family-run company of 14,600 people which provides over 100 countries with vegetables. Well established in the United States, our business unit includes 4 production facilities with more than 3,200 associates. We process fresh vegetables, salads and meal solutions with our own brands: Ready Pac Foods® and Bistro®. Join us at Bonduelle to start an adventure where people come first and contribute to a better future through plant-based food! Bonduelle Fresh Americas is a Certified B Corp for a better life. Bonduelle chose B Corporation because of its comprehensive and rigorous standards and its ability to measure a company’s governance as well as worker, community, and environmental impact.We aim to make a positive impact on People, Planet and Food, as seen in our global B!Pact objectives. B Corp certification validates our positive impact and tells the world we are part of a community using business as a force for good. Key Responsibilities: Ensure compliance with and maintain all GMP/PPE/Safety, HACCP & Sanitation guidelines and processes. Understand and implement requirements for product sampling and sample product following PCT sampling procedures established by the customer and corporate QA. Sample finished product for Hold & Release PCT sampling as required by customers; prepares logs and submits samples for Hold & Release tests. Conduct seal integrity tests on finished products and ensure PMOs/SMOs perform equipment adjustments as needed to ensure 100% compliance with seal integrity. Identify any and all non-conformances, document and report it to the PMO/SMO and production leads for immediate follow-up; correct abnormalities and restore functioning where needed. Clean and/or fill-up the Haug tank at the start of every shift and maintain tank water level and cleanliness throughout the shift. Log leaks, non-conformances and sample submissions in the QA database. Perform other duties as assigned. Minimum Qualifications: Strong attention to detail. Ability to read, write and speak English; comprehension of basic math. Basic computer skills and ability to multitask. Willingness and flexibility to work in a cold, wet, fast-paced, 24 hour plant environment. Ability to lift up to 50 pounds, ability to climb stairs numerous times a day. Ability to work independently and in a team environment. GED/High School Diploma. Physical Work Environment: While performing the duties of this job, this position entails use of ladders and catwalks to reach production equipment, regularly works near moving mechanical parts and is regularly exposed to extreme cold for extended periods of time. The associate frequently works in high, precarious places. The associate is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually loud.

Posted 30+ days ago

QA/QC Specialist – Journeyman-logo
QA/QC Specialist – Journeyman
CACIDoral, Florida
QA/QC Specialist – Journeyman Job Category: Project and Program Management Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: Up to 10% Type of Travel: Local * * * CACI is seeking an experienced QA/QC Specialist to support our customer, U.S. Southern Command (USSOUTHCOM), in Doral, Florida. This position is contingent upon award of the USSOUTHCOM Cyber Information Technology Enterprise Services (SCITES). Key Responsibilities QA/QC Specialist - Journeyman : Assists in ensuring the quality control and timely production of program deliverables Identifies and implements quality control approaches that align with task order requirements Participates in development and facilitation of project Kick-Off Meetings Contributes to the development, delivery, and maintenance of the PMP, including management approaches, organizational structure, work breakdown structure (WBS), risk assessment/mitigation strategies, operating procedures, and Standard Operating Procedures (SOPs) Coordinates and participates in monthly PMRs Tracks and retains all trip reports and related information Assists in development and ongoing maintenance of the Quality Management Plan (QMP), documenting approved approaches for quality assurance, quality control, and continuous improvement Conducts periodic quality control and assurance audits of contract deliverables and processes Monitors and controls quality activities as outlined in the QMP Measures and tracks contract performance objectives , maintaining a comprehensive repository of metrics Gathers and prepares performance feedback for subcontractors to be input into the CACI Procure to Pay (P2P) system and Subcontractor Performance Scorecard Suggests improvements to enhance overall quality Collaborates with the CACI Operational Excellence Team to coordinate and support Excellence+ reviews, contributing to the continuous improvement of program operations Supports technical working groups and program deliverables (such as the PMP) as needed Possesses and applies expertise on multiple complex work assignments Operates with appreciable latitude in developing methodology and presenting solutions to problems Required Skills : Current Secret Clearance with eligibility to obtain TS is Requires expert knowledge of and ability to apply advanced technical principles, theories, and concepts Demonstrated ability for oral and written communication with the highest levels of management and delivery of required reports in accordance with formal contractual agreements. Experience executing process improvement for large scale programs. BS degree and 8-12 years of relevant experience or Masters with 6-10 years relevant experience. - ________________________________________________________________________________________ What You Can Expect: A culture of integrity. At CACI, we place character and innovation at the center of everything we do. As a valued team member, you’ll be part of a high-performing group dedicated to our customer’s missions and driven by a higher purpose – to ensure the safety of our nation. An environment of trust. CACI values the unique contributions that every employee brings to our company and our customers - every day. You’ll have the autonomy to take the time you need through a unique flexible time off benefit and have access to robust learning resources to make your ambitions a reality. A focus on continuous growth. Together, we will advance our nation's most critical missions, build on our lengthy track record of business success, and find opportunities to break new ground — in your career and in our legacy. Your potential is limitless. So is ours. Learn more about CACI here. ________________________________________________________________________________________ Pay Range : There are a host of factors that can influence final salary including, but not limited to, geographic location, Federal Government contract labor categories and contract wage rates, relevant prior work experience, specific skills and competencies, education, and certifications. Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives. We offer competitive compensation, benefits and learning and development opportunities. Our broad and competitive mix of benefits options is designed to support and protect employees and their families. At CACI, you will receive comprehensive benefits such as; healthcare, wellness, financial, retirement, family support, continuing education, and time off benefits. Learn more here . The proposed salary range for this position is: $62,200-$130,600 CACI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, age, national origin, disability, status as a protected veteran, or any other protected characteristic.

Posted 30+ days ago

Engineer I, QA-logo
Engineer I, QA
Thermo Fisher ScientificMarietta, Ohio
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. Location/Division Specific Information Located in Marietta, OH, at 401 Millcreek Road. Join the Laboratory Products Division, aiding life sciences research and global quality of life. Discover Impactful Work: Join Thermo Fisher Scientific’s Quality Assurance team and make a difference in a global, dynamic organization. Your role will be important in ensuring flawless quality and compliance, supporting our mission to drive growth and innovation. A day in the Life: Knowledge of Regulatory and Quality system requirements (ISO 13485:2016, 21 CFR Part 820) Partnership with other site areas to drive a culture of continuous education of the Quality Management System Participate in Customer / Internal audits Apply problem-solving skills related to quality issues to ensure timely resolution with minimal impact Embrace site PPI initiatives and adopt this methodology in day-to-day tasks Participate in plant-wide efforts in corrective and preventive actions, focusing on customer returns and root cause solutions. Provide Quality support for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs Keys to Success: Ability to communicate effectively with multiple levels of leadership. Proficiency in technical writing and experience with various software applications, including Excel Possess organizational to manage and prioritize multiple tasks Ability to achieve deadlines in a fast-paced environment Capability to work independently and collaboratively Education Minimum Bachelor's degree; 0-3 years' equivalent experience preferred; applicable experience will be considered Experience Three years’ experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred Three years’ experience in a manufacturing environment required Knowledge and experience working in the manufacturing of medical devices preferred Knowledge, Skills, Abilities Strong analytical and problem-solving skills Effective interpersonal skills across all organizational levels Strong technical writing abilities and familiarity with software applications like MS Office or similar, SAP, Salesforce. Capable to prioritize in a fast-paced manufacturing organization. Model the principles of the quality culture. Experienced in investigations and root cause analysis, non-conforming product and CAPAs. Physical Requirements / Work Environment This role requires the ability to work standing, walking, and occasionally lifting up to 25 pounds. Adherence to safety protocols is required. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Posted 30+ days ago

QA Tech 1st Shift-logo
QA Tech 1st Shift
OSI CareersOakland, Iowa
Perform a variety of line audits and tests during production to ensure that product is being made within specification and that proper production and sanitary procedures are being followed. Job Responsibilities • Audit line internal temperature of cooked products; record. • Audit metal detectors with the use of standards; if detector is faulty, retain product and re-test product made since last successful test. • Perform line audits, recording speed, temperature, weights. • Perform weekly swabs of equipment/gloves and plates of air; package with instructions and send to lab. • Once per shift, gather cooked and raw product samples to send to lab with testing instructions. • Maintain and test shelf life samples; perform organoleptic duties. • Inspect code dates on bags, boxes, and cases based on product specification and production schedule. • Inspect and record cooler and freezer temperatures. • Cook samples 2-3 times per shift from all lines. • Perform hourly piece count of packed box. • Calibrate scales and thermometers daily. • Complete paperwork on employee sanitation compliance. • Follow all safety rules. • Use Personal Protective Equipment (PPE); recognize and practice Good Manufacturing Procedures (GMP). • Keep assigned area clean. • Perform other duties as assigned. Experience & Skills • 3 months of on the job training.

Posted 30+ days ago

Senior/Principal QA Specialist (Contamination Control, Aseptic Operations and Microbiology)-logo
Senior/Principal QA Specialist (Contamination Control, Aseptic Operations and Microbiology)
GenentechHillsboro, Oregon
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 manufacturing units, which combine to produce millions of units of life-saving medicine every year to patients around the world. The Opportunity: In this exciting role, you will be part of a highly engaged team that is committed to delivering high quality medicines to patients. You will provide Quality oversight for the contamination control strategy, aseptic operations and microbiology. You will serve as a subject matter expert (SME) and resource for the site on aseptic principles including disinfection, environmental control / monitoring. You will provide guidance to internal and external customers on best practices for executing consistent, reproducible, and compliant contamination control strategies and contamination remediations. You will support validation activities for new facilities and utilities. You will provide technical assessment and approval for changes to the contamination control strategy. You will provide Quality authorization for facility and utility restarts following construction or facility wide maintenance to ensure the environmental control and monitoring.. You will provide input to investigations and deviations involving suspect equipment, utility or facility failures. You will support the development and preparation of regulatory submissions related to the contamination control strategy and environmental monitoring of Genentech manufacturing facilities and processes. You will support training of Manufacturing and Quality on aseptic practices, aseptic processing and aseptic media fills You will collaborate with departments to ensure that environmental control and monitoring activities are executed efficiently for nonroutine activities. Who you are: You hold a B.A. or B.S. degree (preferably in a life science) For the Senior QA Specialist level, you have a minimum of 8 years' experience in the pharmaceutical or biopharmaceutical industry. For the Principal QA Specialist level, you have a minimum of 11 years’ experience in the pharmaceutical or biopharmaceutical industry; or an equivalent combination of education and experience. You have an ability to interpret and relate quality standards for implementation and review. You have the ability to make sound decisions about Quality and technical subjects. You exhibit sound knowledge of cGMPs or equivalent regulations You have flexibility in problem solving and work hours to meet business objectives You have strong technical knowledge of aseptic practices, aseptic processing, cleanroom behaviors and contamination control strategies. You are able to quickly and consistently establish rapport and collaborate effectively with clients, team members and partners.​ The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $94,000- $174,000 (Senior level) or $114,000- $211,900 (Principal level). Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Link to Benefits Relocation benefits are provided #gnehtoquality Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

Posted 1 week ago

QA Specialist I/II-logo
QA Specialist I/II
KBI BiopharmaDurham, North Carolina
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. Specialists routinely collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities during a 12-hour 2-2-3 schedule, including but not limited to: Executed Batch record review and approval Logbook review and approval Deviation guidance and generation Routine facility walkthroughs Facility response for work compromising clean environment. SOP review Bulk Fill Label reconciliation Alarm response and acknowledgement Support external client review and resolution of comments. Creation and Release of electronic Batch Records, electronic Solution Records, electronic Equipment Preparation Records, etc. in MODA-ES Admin Client MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. Review written procedures for accuracy and provide feedback as needed MQA Specialist II Associate degree / Bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-6 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Demonstrated ability to become qualified trainers. Ability to track and trend department metrics. Review written procedures for accuracy and provide feedback as needed Salary Range: MQA Specialist I: $55,000 - $75,900 MQA Specialist II: $63,000 - $86,900 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com . KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 3 days ago

QA Analyst-logo
QA Analyst
Slide InsuranceTampa, Florida
Slide Insurance - Fun. Innovation Driven. Fueled by Passion, Purpose and Technology. At Slide, you will not only be part of a successful team, but you will also be a part of our Slide Vibe/award winning culture where collaboration and innovation are expected, recognized and awarded! Duties and Responsibilities Creates and executes clear, concise, and detail-oriented test plans for functional testing, regression testing and user-acceptance testing. Understands and creates test plans from business requirements, specifications, or verbal communications. Maintains test cases to ensure they reflect the current system behavior and to reduce the need to clarifications with the development team or business partners. Evaluates, improves and documents testing processes and procedures. Help create standardized quality processes including test plan development, test documentation, test metrics, best practices and reporting and visibility for overall quality of our systems. Assists business partners by supplying test coverage and results information, facilitating demonstrations of the updated functionality. Perform other duties, as assigned. Requirements Bachelor's degree in computer science or related field, or High School diploma and equivalent relevant work experience required. 2+ years QA experience required. Experience in P&C insurance required Qualifications/Skills and Competencies: Knowledge of quality assurance methodologies, tools, and best practices. Familiarity with software development life cycles (SDLC) and agile methodologies. Strong analytical and problem-solving skills to identify and address quality issues effectively. Excellent communication and interpersonal skills to collaborate with cross-functional teams. Experience in implementing test automation and familiarity with testing tools and frameworks. A passion for delivering high-quality software products and exceptional customer experiences. Strong interpersonal skills. Excellent verbal and written communication skills and the ability to make presentations to internal and external groups. Ability to work independently as needed and use general office equipment. Ability to prioritize effectively. Passion for nurturing ideas and solutions to deliver exceptional customer experiences and outcomes. Demonstrate strong organizational skills. Strong interpersonal skills. Excellent verbal and written communication skills. Ability to work independently and prioritize effectively. Ability to think critically and objectively. Proficient in MSO/365 applications such as Microsoft Teams, SharePoint, Word, Excel, PowerPoint and Outlook. Desire to live Slide's Core Values. What Slide offers to you: The Slide Vibe - An opportunity to be a part of a fun and innovation-driven culture fueled by Passion, Purpose and Technology! Slide offers many opportunities to collaborate and innovate across the company and departments, as well as get to know other Sliders. From coffee chats, to clubs, to social events - we plan it, so all Sliders feel included and Enjoy their Journey. Benefits - Created using Slider feedback, Slide offers a comprehensive and affordable benefits package to cover all aspects of health...Physical, Emotional, Financial, Social and Professional. A Lifestyle Spending Account is set up for each Slider and Slide contributes to it monthly for use on any benefit that individually suits you - Health Your Way! 2023, 2024 & 2025 BEST PLACE TO WORK - Tampa Bay Business Journal 2024 & 2025 TOP WORKPLACE - Tampa Bay Times (Local) & 2024 TOP WORKPLACE - USA Today (National)

Posted 30+ days ago

QA Inspector I-logo
QA Inspector I
Envista DentistryMadison, Wisconsin
Job Description: The QA Inspector I is responsible for receiving and performing quality inspection of incoming material, in-process, and finished devices to ensure compliance with established specifications. Essential Duties and Responsibilities Perform quality inspection and tests on incoming material, in-process, and finished devices to ensure compliance with established specifications Document inspection results according to Good Documentation Practices (GDP) Identify nonconforming material and escalate to the Material Review Board (MRB) Perform Complaint Handling activities (MDR Review and Complaint Closure) according to prescribed timeframe requirements Interact with various cross-functional departments including engineering, manufacturing, and R&D in a collaborative team environment Follow departmental Standard Operating Procedures and Work Instructions Other duties may be assigned by QA Supervisor Incidental Duties The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Job Requirements: Education : High School diploma or equivalent Language Ability : Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to communicate effectively with groups of employees within the organization. Ability to perform these functions in English. Preferred Skills: Experience: One to three years’ related experience and/or training, preferably in the Medical Device or Pharmaceutical industry or technical field. Computer Skills : Experience working with electronic processes (e.g. Word, Excel, Oracle, SAP) Math Ability: Ability to add, subtract, multiply and divide in all units of measure, using whole numbers and decimals. Technical Skills : Experience with basic inspection techniques and tools (use of micrometers, calipers, lensometers, etc.). Able to understand product applications, specifications, functionality, structure, assembly and test methods/processes. Reasoning Ability : Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving multiple variables in standardized situations. Abilities : Detail orientation, precise work, excellent verbal and written communication skills, ability to collaborate effectively across multifunctional teams. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employee is required to sit at a desk for long periods of time Frequently uses hands and fingers, o ccasionally reaches up/down with arms Position requires occasional standing and walking Position requires occasional bending and stooping The noise level in the environment is moderate PPE- Safety glasses required worn by all personnel in production areas or as indicated #LI-TP1 IND123 Target Market Salary Range: Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans. $17.90 - $24.20 per hour Operating Company: Orascoptic Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf. Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Posted 3 days ago

QA & QC Engineer-logo
QA & QC Engineer
Air LiquideSanta Ana, California
Air Liquide Global E&C Solutions is a technology partner of choice for the design, engineering and construction of leading-edge processing facilities and related infrastructures worldwide. We enable our customers to optimize the use of the planet's natural resources in order to provide clean and sustainable energy thanks to our people and their capability to innovate constantly. Through cutting edge innovation applied to our proprietary technology we contribute to the transformation of the energy industry and help to preserve & protect the atmosphere of our planet. Looking back on decades of operational expertise within the world leader in gases for industry, health and the environment, we develop creative, safe, reliable and competitive solutions for our customers, proposing a sustainable worldwide offer of best-in-class plants in a dynamically changing marketplace. Air Liquide’s ambition is to be a leader in its industry, deliver long term performance and contribute to sustainability - with a strong commitment to climate change and energy transition at the heart of its strategy. Candidates must have valid employment authorization in the U.S. and must not require visa sponsorship now or in the future. This position is not open for non-immigrant visa sponsorship . How will you CONTRIBUTE and GROW? QA/QC Engineer to monitor and improve the quality of our operational processes and outputs. A successful quality engineer should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards. In this highly visible role, you will have the opportunity to make a significant impact on our production floor and leave a footprint for years to come. We have an opportunity for an accomplished quality engineer to join our team that is ready to take on the role in stride and support our goals and objectives within our organization. Monitoring and analyzing quality performance through tracking of KPI (rejection rates, cycle times, cost of quality). Document all CARs, SCARs, FMEAs, FTR (Field Service Reports) s to improve the quality of our organization. Complete root cause analysis and capture all non-conformances within our organization. Act as lead auditor that supports our QMS, creating action plans to ensure sustainment. Prepare internal audit plan and coordinate with respective dept. Work with internal teams to increase customer satisfaction by improving the quality of our products. Preparing reports by collecting, analyzing and summarizing data. Implement advanced product quality planning activities to support new product development, processes, designs, and systems. Collect and maintain vendor certificates and generate MDR (material data reports) for customers. Report VDDRs and assess impact to the production schedule and QMS. Cross train department in QMS procedures. Develops, documents, and improves policies, procedures, and work instructions to support the enhancement of the Quality Management System. Analyzes scrap, rework, and customer complaint data to identify trends and suggests improvement methods to prevent future occurrences. Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. Final inspection and PDI (pre-delivery inspection) Proficient in interpretation and usage of ASME Y14.5 (Geometric Dimensioning and Tolerance). Be able to set up, maintain, and use varieties of inspection hand tools (caliper, mic, bore gages, rings & plug gages, profilometer, coating thickness gauge, comparator, sine bar…etc.) Programing and work knowledge on Romer arm NDE (liquid penetrant) certified level II (by ASNT or equivalent) desired. Note: NDE level 1 and 100 hours plus working hours (under Level II supervision) are considerable. Travels to suppliers’ sites for purpose of inspections / audits Red tag creation for rejected parts at receiving inspection Coordination and support to supplier quality engineer (Cryolor, India) and NCR-MRB (Material review board) Train supplier on repeated NCR / defects Perform RCA in collaboration with supplier to identify the root causes Frequently visit new suppliers for NPD and qualify new suppliers based on the request Data analysis and appropriate communication with supplier and internal ALT team Strong knowledge to reduce CoPQ, FTR and NCR Strong knowledge on data analysis, lean and six sigma Are you a MATCH? Education & Experience Bachelor degree in quality, industrial, electrical, or mechanical engineering required A master degree in a related field is preferred. Certified quality ISO 9001:2015 auditor preferred, but not required. Lean six sigma green belt, added advantage 3 to 5 years experience in quality engineering, quality control role Understand ISO 9001:2015 and all of its requirements. Strong communication and interpersonal skills. Strong analytical and problem-solving skills. Excellent attention to detail and in-depth understanding of technical documentation. Computer software such as Google Docs, Google Sheets, and Google Slides. Understanding of lean manufacturing and continually improving methodologies. Knowledge of the statistical methodologies used in quality assurance. Knowledge of continuous improvement methodologies used in quality assurance. Knowledge of machining, welding, non-destructive examination and shop tools, equipment and health and safety requirements. Knowledge of mechanical inspection techniques and the ability to train others to effectively complete inspection Verbal communication skills: speaks clearly and persuasively and responds well to questions; communicates effectively to management and staff. Written communication skills: writes clearly and informatively and presents numerical data effectively in order to produce standard operating procedures, manuals, reports, and quality documentation necessary for regulatory submission and inspections. Analytical skills: Collects, researches, analyzes and synthesizes complex data and makes appropriate decisions based on analysis, sound judgment, and available information. Organizational skills: Works independently and meets commitments and established deadlines for assigned responsibilities and develops strategies to achieve quality goals and objectives. Interpersonal/leadership skills: Engages fellow employees in a respectful and professional manner to build positive team spirit, morale and group commitments; motivates and effectively influences the actions of others and is open to ideas and suggestions provided by others to achieve quality goals and objectives. Computer skills: Proficiency in Microsoft Office software and modern ERP system applications. Ability to accept and perform a variety of work assignments, take on new responsibilities, adjust plans under changing circumstances and provide timely response to department needs, staff and management issues and requests for input from other departments. The annual base salary range for this position in California is $78,000 - $95,000. Please note that the salary information is a general guideline only. Air Liquide considers factors such as (but not limited to) scope and responsibilities of the position, candidate’s work experience, education/ training, key skills as well as market and business considerations when extending an offer. Benefits offered: Medical, Dental, Vision, Life Insurance, Short-Term Disability, Long-Term Disability, 401(k) match, Flexible Spending Accounts, EAP, Education Assistance, Parental Leave, Paid time off, and Holidays. Our Differences make our Performance At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.

Posted today

Specialist QA- US Remote-logo
Specialist QA- US Remote
AmgenThousand Oaks, California
Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist QA What you will do Let’s do this. Let’s change the world. In this vital role you will provide quality assurance support to the Product Quality organization as a subject matter expert of quality systems and records. In this team-based role you will directly add to the success of the Product Quality team by collaborating within PQ and with diverse levels in functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations. The QA Specialist will use technical abilities and knowledge of QMS processes, procedures, and regulations to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures. Additionally, this role will approve commercial variation records (GDCR), and may provide training to other staff. Responsibilities: As a team member you will use your technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits, as needed. The QA specialist may also support managing products in the annual product review cycles at Amgen. Provide QA Systems expertise and QA support to the Product Quality organization (PQ and Stability) by working within a team environment. Provide Product Quality QA support to one or more of Amgen's clinical and commercial products by working directly with Product Quality Leaders and Principal Product Quality Leaders on QA tasks. Responsible for QA tasks in support of both clinical and commercial Product Quality Leaders, including ownership, QA review and approval of documents (Protocols, Reports, Specifications, IPC’s, Annual Product Review, etc.), and execution of transactions (Owner and/or QA Contact) in relevant GMP systems (VEEVA CDOCS, Change Control, Deviation/CAPA, etc.) and may include additional business process support. Support of audits/inspections, APR management, and other processes as required. Supporting/facilitating continuous improvement initiatives intended to increase Quality systems efficiencies within and outside of the PQ organization. Interact with other functional areas within Amgen such as Corporate Quality, International Quality, Quality Control, Regulatory, Process Development, Site Quality Assurance, Supply Chain, Manufacturing, etc. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications. Basic Qualifications: Doctorate degree Or Master’s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience Or Bachelor’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience Or Associate’s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience Or High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience Preferred Qualifications: Understanding of pharmaceutical sciences, quality, compliance and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or commercial products. General understanding of biopharmaceutical bulk and drug product development and manufacturing and general knowledge of cGMP’s. Previous experience using VEEVA, Trackwise and other Amgen quality systems. Quality Assurance experience reviewing and approving cGMP documentation (Protocols, Reports, Specifications, SOP’s, etc.). Strong Investigation skills (related to Deviations/CAPAs/EVs) and/or experience owning change control records. Experience with Amgen variation management processes and systems. Experience working on a cross-functional team in a matrix environment and strong project management skills. Excellent written and verbal communication skills, including facilitation and presentation skills. Competency in interacting with Senior Management. Strong organizational skills and the ability to manage and prioritize multiple/competing tasks and deliverables. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 109,307.00 USD - 129,509.00 USD

Posted 1 week ago

QA Supervisor-logo
QA Supervisor
Kindeva Drug Delivery/Summit BiosciencesLexington, Kentucky
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: Responsibilities: Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures Leads the day-to-day activities of the QA group with respect to the writing, review and approval of GMP documentation. Participate in all plant activities and leads continuous improvement objectives to ensure cGMP compliance. Advises management on findings and recommendations related to internal and external auditing and implements changes Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents. Oversee the deviation and events management system. Develop and implement training qualification programs for QA team members. Develops and maintains metrics and trending reports for Compliance-related activities. Reviews and approves product complaint investigations and assists with investigations. Leads activities associated with various one-time or on-going projects (from participation level to project manager). Collaborates with departments and external suppliers regarding quality concerns. Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.). Leads regulatory inspections and customer audits. Assist Manager with daily and project activities as needed. Maintain current knowledge of new regulatory developments. Other duties as assigned. Qualifications: Basic Qualifications: Bachelor’s degree in a scientific discipline preferred At least 6 years Pharmaceutical/Medical Device cGMP quality experience Excels in organizational and leadership skills and attention to detail Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization Familiar with the necessary components of facility qualification and validation activities. Extensive knowledge of cGMP regulations and ICH guidelines. Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners Ability to work in a lean, action oriented organization and demonstrate a strong work ethic Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team Qualified to work with controlled substances Physical Requirements: Regular use of hands for documentation, equipment operation, and material handling Extended periods of standing and walking Ability to lift/move Full range of vision capabilities (close, distance, color, peripheral, depth) Must wear required PPE and follow cGMP/safety procedures Lift heavy equipment up to 60 pounds occasionally, climb ladders, and work in confined spaces. # LI-Onsite

Posted 5 days ago

Director, QA - Activision-logo
Director, QA - Activision
Activision PublishingMinneapolis, Minnesota
Job Title: Director, QA - Activision Requisition ID: R025272 Job Description: Your Platform Founded in 1979, Activision has continuously disrupted the world of entertainment as a leader in the videogame industry. With a history of delivering iconic game changers -- like Pitfall® , Tony Hawk®, Guitar Hero®, Crash Bandicoot™, Skylanders ™ and Call of Duty ® -- our obsession is delighting our players around the globe. Focused and committed to innovation, we consistently deliver the most beloved, engaging and successful entertainment. And while we have world-class franchises, infrastructure and resources, our success comes from a passionate, talented and diverse team of people producing greatness together. So, if you’re interested in our biggest priority, it’s our people. We’re currently driving the next era for our company and community by creating amazing experiences for fans and continuing to make Activision an inclusive place where everyone can thrive. Join us, make history. To learn more, check us out at www.activision.com , www.activisiongamesblog.com or @Activision on Instagram, X, Facebook and LinkedIn. Your Mission The QA Director is responsible for overseeing multiple projects and teams through the Quality Assurance test process. The QA Director at Activision is the primary point of contact for all QA matters on multiple concurrent projects. Additionally, the QA Director is responsible leading the performance management process; ensuring that both the testing population and management team are held accountable to the standards set by the department’s senior leadership Reporting to the Senior Director, the QA Director works closely with the various Studio leaders as well as the internal QA management team to create test plans, refine testing procedures using our internal tools while also championing innovation where possible, improve QA efficiency and help drive the success of the QA team. This involves assigning and managing test leads and test teams, planning and managing the QA budget and test plan, coordinating with the Studio management team as well as first parties, and overseeing the entire test effort from beginning to end. The QA Director works to ensure that each project is tested in line with best company practices, and participates in overall department planning, process improvement, performance management, leadership development, and policy making. Priorities can often change in a fast-paced environment like ours, so this role includes, but is not limited to, the following responsibilities: With the support of QA Managers and in conjunction with the Project Lead teams, oversee the entire internal QA effort at the Bloomington, MN office. Coordinate and oversee all Activision QA efforts. Work directly with QA management and Studio teams, assisting on projects to ensure all testing areas are covered, that test plans are being followed, and that the collective effort of all QA for the title is working in concert. Ensure that Activision games ship at the highest possible quality by putting processes in place to test all areas of the game, and by highlighting issues to the Studio Leaders. Push back against the Studios when you feel that they may be choosing not to address an issue in error. Work with Senior Project Leads, Project Leads, and Associate Project Leads to ensure QA provides work in progress dev testing where needed to Studio leadership. Ensure that first party technical requirements are properly tested and bugged. Identify areas of opportunities within the QA department that could be streamlined or improved upon via various process improvement methodologies, utilizing AI where applicable. Work with QA management to maintain the highest level of Jira cleanliness. Organize frequent regressions to clear out stale issues. Actively cull orphaned components and fields. Partner with the various management teams within QA, from Senior Project Leads to the Associate Project Lead levels, to identify better ways to report bugs found during testing and report back to the larger testing team so that they can be reproduced and logged. Create a streamlined process for allowing developers to make testing requests and a method by which those requests or tickets can be tracked in a queue. Provide accurate and timely test plans and workforce estimates to all stakeholders to inform decision making and budgeting. Work with QA management to determine the best ways that the department can support all the Studios. Determine types of testing coverage, tools that can be implemented, etc., to allow QA to meet the needs of all Studios. Proactively identifies and solves productivity and personnel issues, partnering with Human Resources and Employee Relations regularly to ensure policies and practices are upheld consistently. Leads by example. Supports and mentors site leads, to help them grow and own their own areas. Build a culture of performance management through every level of the QA department, emphasizing accountability, development, and building a talent bench of future managers. Prepare qualitative assessments and data driven tracking reports Help develop and evolve new and existing Quality Assurance methodologies at Activision. Act as the liaison between QA and the various Studios that produce our titles. Work directly with the Studios to improve build delivery times and efficiency. Work closely with the automation team to drive testing initiatives and incorporate tools into the testing process. Must excel at communication with the various groups within the organization, such as Development teams, Central Tech, Automation and QA Leadership. Partner with our external test teams to ensure quality output and best practices are maintained Identify and anticipate risks. Present solutions. Provide regular reports of key actions and risks at various levels of detail. Player Profile Minimum Requirements: 12+ years of applicable experience in the video game industry and at least 4 years leading a large-scale departmental team. Comprehensive understanding of testing methodologies, test plan organization, and technical requirements. Leadership and the ability to teach and impart their experience and knowledge unto others. This includes having demonstrated experience in people and leadership development. Analyzing a combination of performance metrics and documented feedback to champion a culture of performance management within a large population of individual contributors and leaders. Track record of comprehensive test plans being successfully executed leading to the timely delivery of quality projects. Strong time-management skills with the ability to focus on priorities, manage change and be flexible to changing requests, delegate responsibilities, and deliver against agreed deadlines. Proficiency in MS Office Proficiency in use of database and defect tracking tools, e.g. Hansoft, Jira, DevTrack. Testrail Exemplary written and verbal communication skills. Proven ability to work under rapid development cycles. Very organized. Open-minded personality and team-player mentality. Knowledgeable of our games and experience with all facets of first person shooters (Single Player, Multi-Player, Co-Op). Our World Activision Blizzard, Inc is one of the world's largest and most successful interactive entertainment companies and is at the intersection of media, technology and entertainment. We are home to some of the most beloved entertainment franchises including Call of Duty ®, World of Warcraft® , Overwatch ®, Diablo ®, Candy Crush ™ and Bubble Witch ™. Our combined entertainment network delights hundreds of millions of monthly active users in 196 countries, making us the largest gaming network on the planet! Our ability to build immersive and innovate worlds is only enhanced by diverse teams working in an inclusive environment. We aspire to have a culture where everyone can thrive in order to connect and engage the world through epic entertainment. We provide a suite of benefits that promote physical, emotional and financial well-being for ‘Every World’ - we’ve got our employees covered! The videogame industry and therefore our business is fast-paced and will continue to evolve. As such, the duties and responsibilities of this role may be changed as directed by the Company at any time to promote and support our business and relationships with industry partners. Activision is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, or any other basis protected by applicable law and will not be discriminated against on the basis of disability. Rewards We provide a suite of benefits that promote physical, emotional and financial well-being for ‘Every World’ - we’ve got our employees covered! Subject to eligibility requirements, the Company offers comprehensive benefits including: Medical, dental, vision, health savings account or health reimbursement account, healthcare spending accounts, dependent care spending accounts, life and AD&D insurance, disability insurance; 401(k) with Company match, tuition reimbursement, charitable donation matching; Paid holidays and vacation, paid sick time, floating holidays, compassion and bereavement leaves, parental leave; Mental health & wellbeing programs, fitness programs, free and discounted games, and a variety of other voluntary benefit programs like supplemental life & disability, legal service, ID protection, rental insurance, and others; If the Company requires that you move geographic locations for the job, then you may also be eligible for relocation assistance. Eligibility to participate in these benefits may vary for part time and temporary full-time employees and interns with the Company. You can learn more by visiting https://www.benefitsforeveryworld.com/ . In the U.S., the standard base pay range for this role is $107,200.00 - $198,320.00 Annual. These values reflect the expected base pay range of new hires across all U.S. locations. Ultimately, your specific range and offer will be based on several factors, including relevant experience, performance, and work location. Your Talent Professional can share this role’s range details for your local geography during the hiring process. In addition to a competitive base pay, employees in this role may be eligible for incentive compensation. Incentive compensation is not guaranteed. While we strive to provide competitive offers to successful candidates, new hire compensation is negotiable.

Posted 30+ days ago

Quality Assurance & Quality Control (QA/QC) Specialist-logo
Quality Assurance & Quality Control (QA/QC) Specialist
FerrovialCharlotte, North Carolina
About us: I-77 Mobility Partners LLC is financing, developing, designing, constructing, operating and maintaining the 26-mile I-77 Express project as part of a public-private partnership with the North Carolina Department of Transportation. The tolled express lanes run adjacent to the general-purpose lanes on I-77 between uptown Charlotte and Mooresville. I-77 Mobility Partners is responsible for operations and maintenance of all lanes, both express and general purpose, and right of way within the designated project corridor limits. What makes us different? Our people come first. We want every single employee to develop both professionally and personally. With a strong focus on growth potential, we look to our internal employees as potential candidates for both national and international opportunities. We aim to achieve greatness by promoting from within every chance we get. We work hard and play hard and strive every day for success and achievement. With a diverse group of professionals working in a fast-paced environment, we achieve milestones constantly. And if that weren’t enough, we also offer our employees highly competitive insurance benefits, Paid Time Off, and a matching 401(k) program. Job Description: Summary: The Quality Assurance & Quality Control (QA/QC) Specialist is responsible for assisting to ensure company policies are followed, monitoring compliance with applicable regulations, identifying potential hazards in the workplace, and assisting with incident investigation and corrective action implementation to eliminate nonconformities and hazards; they typically conduct regular inspections and internal audits, prepare reports for HSEQ management, and support risk identification and mitigation through proactive measures. Essential Duties and Responsibilities: Conducts HSEQ related audits, inspections and gap assessments Coordinate and attend any Quality Management review process in order to assess effectiveness of the Quality Management System making adjustments as deemed necessary Implement, review and maintain quality procedures including audit procedures for all other departments Proactively identify and assess potential workplace hazards and risks (including ergonomic, chemical, and physical risks) and recommend and support mitigation strategies. Support with implementation of facility waste reduction initiatives. Manage document control and repository activities. Provide back-up support to night shift Safety Specialist as needed. Assist HSE Manager with implementation of safety initiatives. May assist with planning employee events related to HSEQ. Assist with tracking and assigning training in KPA Creates or assist with creation of employee training presentations. Assist with monthly reporting requirements. Work closely with supervisors and employees to promote a safety-first culture, addressing concerns and providing safety guidance May perform other duties as assigned. Qualifications (Knowledge, Skills & Abilities): 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 to fulfill those duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education & Experience: Associate’s degree or equivalent work experience 3+ years of experience in a HSEQ role with internal auditing experience Experience with ISO 9001 standards is preferred Professional Qualities: Highly motivated Strong critical thinking skills Superior organizational and self-management skills, including the ability to proactively manage tasks with strict deadlines Ability to interact with colleagues in a self-managed team structure Must be able to multitask, problem-solve, and implement innovative processes within a fast-paced environment Superior quantitative skills Superior written and verbal communication skills, particularly technical report writing skills Computer Skills: Proficiency with Microsoft Office Products including Word, Excel and PowerPoint as well as Outlook. Experience with Power BI a plus Work Environment & Physical Demands: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet Some travel required, may include air travel The employee must occasionally lift and/or move up to 10 pounds Specific vision abilities required by this job include ability to adjust focus, as necessary to use a computer While performing the duties of this job, the employee is regularly required to talk or hear

Posted 1 week ago

Quality Assurance (QA) Lead for Chemical Standards Manufacturing-logo
Quality Assurance (QA) Lead for Chemical Standards Manufacturing
Agilent TechnologiesNorth Kingstown, Rhode Island
Job Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek – so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. The Chemistries & Supplies Division develops, manufactures, procures, and supports state-of-the-art consumables including liquid- and gas-phase separation columns, sample preparation, chemical standards, performance chemicals, glycobiology and bioanalytical proteins, and a full portfolio of supplies for life science instrumentation. Our Global Quality & Regulatory Affairs organization owns and maintains a robust ISO 9001 Quality Management System (QMS) for use by all functions in the division. The organization is also responsible for maintaining hardware and chemical/biological regulatory compliance, where applicable. Our Product Support organization assists customer and field service as well as providing customer feedback insights to the division. Our organization leads and supports continuous improvements to ensure compliance and efficiency. The manufacturing site for this position produces chemical standards, including reference materials certified to ISO 17034 and validated under ISO 17025, controlled substances registered with the Drug Enforcement Agency (DEA). This position offers a hybrid working location requiring at least three (3) days per week on site. The Quality Assurance Lead for the site is responsible for: Owning and improving the division and local ISO 9001 QMS including alignment to Agilent- and group-level QMS. Ensuring the QMS meets the following additional needs: ISO 17034 for the site as a Reference Material (RM) Producer, and ISO 17025 for the site as a Testing and Calibration Laboratory, and Manufacturer of DEA controlled substances. Monitoring customer feedback, non-conformance, and operational performance metrics to identify trends and driving corrective actions and continuous improvements, as appropriate. Representing Quality Assurance on cross-functional teams for the Product Lifecycle and Design Control. Creating and conducting quality training with proper effectiveness verification and traceability. Collaborating with cross-functional division and site leads to ensuring the organization is sufficiently trained. Leading Corrective and Preventative Action (CAPA) program at the division and site level. Preparing and communicating division and local quality reviews including customer complaints (defects on arrival, warranty, product safety events, customer surveys, etc.), achievements and customer satisfiers, and proactive change notification. Leading external (registrar and customer) and internal audits as well as regular site-evaluation assessments. Tracking audit findings and collaborating with site management to develop corrective action plans and drive to closure. Upon request, managing customer quality and change control agreements, questionnaires, and Supplier Corrective Action Reports (SCAR). Leading customer communication to ensure quality and contractual compliance. Partnering with Regulatory Affairs to understand and implement requirements such as Safety, Electromagnetic Compatibility (EMC), Materials of Concern (MoC), Environmental Health and Safety (EHS), Safety Data Sheet (SDS), etc. Partnering with Product Support to gather and analyze customer feedback to identify and implement corrective actions, corrections, and continuous improvement. Qualifications University degree, or equivalent, in Chemistry, Life Sciences, Engineering, or related field. 4+ years' experience with Quality Assurance, ISO Compliance, and/or Quality Management Systems. Experience with ISO 9001:2015, or similar, required. Experience with ISO 17034:2016, or similar, required. Experience with ISO 17025:2017, or similar, required. Knowledge of DEA controlled substances preferred. Familiarity with the Corrective and Preventive Action process (CAPA) required. Analytical skills (Root Cause Analysis (RCA), Six Sigma, MSA, Failure Modes and Effects Analysis (FMEA)) knowledge preferred. Experience and practical application of Continuous Improvement tools and mindset preferred. Effective communication skills and ability to work independently and collaborate with cross-functional and global teams. Additional Details This job has a full time weekly schedule. Applications for this job will be accepted until at least May 22, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $97,920.00 - $153,000.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility. Travel Required: No Shift: Day Duration: No End Date Job Function: Quality/Regulatory

Posted 1 week ago

Sr. Director Operational QA-logo
Sr. Director Operational QA
AldevronFargo, North Dakota
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences. Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This position is part of the Quality department located in Fargo, ND and will be On-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Assurance Department and report to the VP of Quality responsible for creating and executing on the Quality Assurance Strategy. Job Responsibilities: The creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic direction and vision as well as the tactical leadership necessary to consistently improve. Supports the company in assuring it is operating in accordance with applicable regulations, standards and guidance related to clinical and commercial activities and helps maintains positive audit results. Serve as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality Agreements Develop and enhance phase appropriate QMS programs that comply with industry standards for development through commercialization GMPs including but not limited to establishment of quality agreements, management of lot review audit programs, Implementation of QA review for Master and Executed Batch Records, development and oversight of processes supporting inspection and release of incoming raw materials, and implementation of in-process quality assurance review Oversee and manage all aspects of quality functions for quality systems Product Complaints, Product Quality Review, Lot Disposition (raw materials to finished Product release) Establishes and implements metrics (process capability, control charts, measurement quality, etc.) for monitoring system effectiveness to enable sound quality decisions and to improve quality. Provide leadership and management to direct reports including day-to-day supervision, performance management, training, and planning while leveraging team member skills and abilities to ensure goals are achieved. Qualifications: 10+ years of relevant experience in a quality position, required with a minimum of 3 years in a managerial position. Experience with final drug product manufacturing with incoming Quality Management Systems, Quality Assurance and regulatory audits required. Bachelor of Science required; life science related field, preferred. Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, required Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and EudraLex Vol. 4), including regulatory inspection or support experience, preferred Ability to manage priorities, track progress of key projects, and provide updates to leadership as required. It would be a plus if you also possess previous experience in: Experience working in a matrix environment. Experience implementing and executing on cGMP Quality Strategy #LI-GC1 At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

Posted 30+ days ago

Product Engineer II- QA Automation-logo
Product Engineer II- QA Automation
EsriRedlands, California
Overview Be a part of advancing the next generations of ArcGIS Business Analyst. Our team is building user centric analytical tools and spatial content to help organizations make data-driven decisions globally. We are looking for professionals with a passion for improving software products through QA and automated testing. This is a position where you will constantly find ways to improve our operations, identify issues and their cause, automate new ways to improve productivity and apply your problem solving skills to improve the quality of our development cycles. Responsibilities Create, extend, and automate the execution of high-performance and comprehensive test automation Develop structured test plans for each phase and component of the release cycle to reduce errors and isolate problems, including code changes and bug fixes Apply your knowledge of the latest innovative test technologies and techniques to improve product stability and QA environments Maintain and monitor daily test harnesses and strategies, including benchmarking and OKRs problems Automate tests for multiple software, data, and operating environments, both online and on-premise Actively work with developers to evolve testing processes in coordination with advancing software implementation systems Document and enforce workflow patterns to advocate for a consistent and reliable user experience, including becoming an expert in Accessibility requirements and testing Work closely with product engineers to organize and manage goal-focused releases that expand the existing user base Requirements 2+ years of experience with QA processes, test frameworks, writing cases, and automating tests Experience with one of the following languages: Python, Java, C#, or other high-level languages Demonstrable experience in working independently as well as fast fast-moving teams Detail-oriented person with a passion for finding issues, bugs, and organizing solutions Strong analytical problem-solving and communication skills Experience and understanding of ArcGIS Business Analyst system and ArcGIS products Bachelor's in GIS, computer/data science, or related STEM field Recommended Qualifications Understanding of the Agile software development life cycle Experience Jenkins or other automation tools Git and Github processes and techniques Understand statistical concepts Masters in GIS, computer/data science, STEM or related field #LI-AL1 #LI-Hybrid

Posted 2 days ago

Director, QA Clinical Operations-logo
Director, QA Clinical Operations
CatalentHarmans, Maryland
Director, Quality Assurance Clinical Operations Position Summary Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. The Director, Quality Assurance Clinical Operations is responsible for leading and managing quality assurance functions supporting clinical operational activities, ensuring timely and compliant delivery of products while maintaining high-quality standards. The incumbent will oversee real-time batch record review, QA-OTF support, client-facing QA activities, and deviations management. The Director works closely with senior management to meet operational and quality goals and will also be instrumental in ensuring the execution of key deliverables and maintaining the "Patient First" culture. This is a full-time on-site position. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Role Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews. Outlines and executes department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success. Directs the real-time batch record review activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines. Provides investigation direction, support, and department approvals. Ensures investigation CAPA actions are clearly defined, effective in resolving the root causes and are implemented timely. Oversees Client facing personal supporting clinical operations in the roles of Client QA. Directs QA-OTF activities supporting clinical activities including central services and manufacturing operations. Facilitates QA support and works closely with other Catalent functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured. Other duties as assigned. The Candidate Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology preferred). 10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role. 8+ years of leadership experience including performance management. Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish. Exposure to contract manufacturing a plus. Ability to quickly learn new and novel manufacturing processes supporting new clients. Ability to self-direct and adapt to changing priorities. Excellent communication and interpersonal skills required. Strong attention to detail and organization skills required. Why You Should Join Catalent Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .

Posted 3 days ago

Decima International logo
Construction QA Supervisor (On-site) - Phoenix, Arizona
Decima InternationalPhoenix, Arizona
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Job Description

Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula:

Approach each client engagement as a partnership, create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards.

DESCRIPTION

Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula:

Approach each client engagement as a partnership, create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards.

If you are interested in a long and rewarding career working with high-profile clients on some of the most challenging projects in the world, then Decima is where you belong. At Decima, you will be able to explore incredible growth and professional development opportunities.

We are looking for a driven and capable Civil Structure Architecture QA Supervisor to support us with the development of multiple data center projects for one of the top technology clients in the world. This is a client-facing role that requires strong interpersonal, communication, and organizational skills, the ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently and across multiple regions. A strong background in data center development, design, engineering, controls, and operations requirements is a big plus.

You will play an integral role in ensuring the implementation and management of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction inspection and testing services of a project. The Civil Structure Architecture QA Supervisor is accountable for the guarantee of the work performed, as well as meeting the project’s contractual requirements set forth by the client.

We are looking to bring in dedicated individuals with a passion for innovation and talent for multitasking in a fast-paced environment. We will help you grow, pursue, and fulfill what inspires you so we can make big impacts on the world, together.

RESPONSIBILITIES

  • Develop a sound knowledge of the project scope and requirements.
  • Ensure compliance with stringent contract and owner quality requirements.
  • Prepare comprehensive, project-specific QC plans.
  • Review and verify material submittals for A/E and Client review.
  • Verify delivered materials comply with approved submittals.
  • Provide and review submittals, RFI logs, maintenance logs, and other project-related materials in a timely manner.
  • Review and update QC punch lists and coordinate punch list completion with GC and subcontractors.
  • Verify the implementation and operation of the quality assurance and control systems by planning and conducting internal quality audits and inspections of activities on site.
  • Ensure implementation and continuous improvement in overall Quality Systems.
  • Ensure that all contractual / company and local authority requirements for Quality, Health, Safety & Environment (HSE) requirements are complied with.
  • Review, update, and verify the distribution of the Quality Management Procedure, Quality Manual, and related procedures for Infrastructure, MEP, Civil, and other subcontractors and divisions by the GC.
  • Verify that GC implements adequate training/awareness of company personnel for Quality systems.
  • Ensure that all non-conformance issues are promptly investigated, corrective and preventive actions are proposed/implemented, and are quickly closed out.
  • Ensure that the contractual quality requirements of a project are fully communicated to all key personnel, so that their roles in fulfilling these requirements are fully understood.
  • Ensure that all GC and subcontractors' quality systems and plans are acceptable to the company as applicable to the "Project Contract".
  • Ensure that Subcontractors'/Suppliers' quality systems are implemented and effective.
  • Ensure that the calibration of all inspection, measurement, and test equipment is conducted according to the defined schedule.
  • Conduct reviews of the approved suppliers and subcontractors' list.
  • Liaise with the General Contractor, Client, and Project Management team to ensure that all potential and actual quality issues are fully resolved.
  • Establish a strong relationship with the GC and Client, and communicate with both technical and management-level personnel.
  • Prepare PowerPoint decks and present to management on progress, findings, and recommendations.
  • Review project plans, requirements, and specifications.
  • Perform other related duties as required and assigned.

QUALIFICATIONS

Required Qualifications:

  • 15+ years of construction quality management experience.
  • Bachelor's degree in Civil, Structural, Architectural Engineering, or a related field.
  • Experience with managing field engineering, inspection, and NDE related to all QA/QC functions.
  • Ability to develop and manage non-conformance, deficiencies, and reporting programs, including root cause analysis.
  • Experience in developing and monitoring project QA/QC budgets.
  • Ability to ensure that correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded.
  • Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor.
  • Experience working as a QA/QC Manager for large Commercial, Industrial, or Mission-Critical Facilities construction projects.
  • An excellent understanding of construction Quality Management Systems (QMS).
  • Experience developing various types of reports, targeting different audiences.
  • Experience in client-facing positions.
  • Demonstrated ability to understand technical and complicated construction programs and the ability to communicate progress to both technical and management-level personnel.
  • Strong communication skills, including the ability to communicate with any audience clearly and accurately.
  • Proficient in Microsoft Office programs.

Preferred Qualifications:

  • Project Management Professional (PMP) certification.
  • Certified Construction Manager (CCM) certification.
  • Strong background in data center development and construction.

 

POSITION DETAILS:

 

  • Primary Location (On-site): Phoenix, Arizona
  • Position: CSA QA Supervisor 
  • Position Classification: Salary-based full-time regular hours
  • Current US work permit required. This position does not offer sponsorship for employment (e.g., H-1B visa sponsorship or transfer not offered)

 

PRODUCTIVITY TOOLS:

  • Microsoft Office
  • Microsoft 365

 

Job Type: Full-time

Schedule: 8-hour shift

Work Location: (On-site)

  • Phoenix, Arizona

Decima International is an Equal Opportunity Employer who is committed to the safety and wellbeing of all. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law.

At Decima International, we offer a competitive salary package, including paid time off and performance-based bonuses. We also provide excellent medical, vision and dental insurance for our employees.