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QA/QC Coordinator-logo
QA/QC Coordinator
E2 OpticsNew Albany, Ohio
Join Our Team as a QA/QC Coordinator at E2 Optics! CLICK HERE to learn more! E2 Optics is a rapidly growing, award-winning, woman-owned technology integrator that specializes in low voltage solutions. We're looking for a Quality Assurance/Quality Control Coordinator to ensure that all our projects are executed in compliance with industry and customer standards. If you have a passion for quality management, experience in cabling or data center installations, and a knack for problem-solving, we want you on our team! Why Join E2 Optics? Award-Winning & Woman-Owned: Be part of a company that’s transforming the technology integration industry. Career Growth: Develop your skills with opportunities for coaching and training. Dynamic Culture: Join a team that embraces innovation, continuous improvement, and a collaborative spirit. What You'll Do: Safety First: Comply with worksite safety standards and promote safety within the team. Quality Assurance: Develop and execute the E2 Optics Quality Management System (QMS) for every project. Collaboration: Partner with internal and external stakeholders to ensure adherence to quality standards. Inspections & Reporting: Conduct quality inspections, generate data analytics, and track nonconformance reports. Continuous Improvement: Drive Lean initiatives and contribute to the success of quality-driven projects. Training & Coaching: Train internal teams on quality standards and procedures. What We're Looking For: Education: High school diploma or GED required. Experience: 2+ years of field experience with structured cabling or data center cabling installations. Experience with fiber installation and testing. Skills: Strong communication and coaching abilities. Analytical, decision-making, and problem-solving skills. Proficient in Microsoft Office (Outlook, Word, Excel). Ability to work under pressure while maintaining a positive, detail-oriented approach. Experience with technical writing and developing QA/QC procedures is a plus. WHAT WE OFFER: - Competitive pay - Opportunities for professional development and career growth. - BICSI Training Facilities - A supportive and inclusive work environment. - Health, dental, and vision insurance. - Paid time off and holidays. WORK ENVIRONMENT & PHYSICAL DEMANDS: The standard work environment for this position is an indoors business office and construction environment. Ability to use a computer and/or hand tools while sitting or standing for extended periods of time. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is regularly required to sit, talk or hear, use hands, stoop, kneel, bend, rotate, push, pull, reach with hands and arms on intermittent to regular basis daily. The employee is frequently required to stand and walk. The employee must regularly lift and/or move up to 50 pounds and frequently lift and/or move up to 25 pounds. The employee must regularly carry and climb ladders to 20 feet. The employee may be required to work in tight, confided spaces. The employee must demonstrate regular and on-time attendance. There could be a requirement of occasional travel by conventional means including aircraft, motor vehicle and the like within the region and to other locations as required. The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. DISCLAIMER: The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions. An Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Actively recruits qualified women, minorities, disabled and veterans for all positions for which they are qualified. TEXTING TERMS OF SERVICE: We may send text messages you have consented to receive. Message frequency may vary. You can cancel text messages at any time by texting "STOP". After you send "STOP", we may send you an additional text message to confirm that you have been unsubscribed. You will no longer receive text messages from that phone number, or from any member of our team. If at any time you have questions about the text messages, text "HELP". After you send "HELP" we will respond with instructions on how to use our service as well as how to unsubscribe. Message and data rates may apply.

Posted 1 day ago

Lead QA Architect-logo
Lead QA Architect
NICE SystemsAtlanta, GA
At NiCE, we don't limit our challenges. We challenge our limits. Always. We're ambitious. We're game changers. And we play to win. We set the highest standards and execute beyond them. And if you're like us, we can offer you the ultimate career opportunity that will light a fire within you. So, what's the role all about? As the Lead QA Engineer, you will play a pivotal role in shaping the quality vision across NICE's flagship product suite. You will define strategic quality goals, align them with business objectives, and lead cross-functional initiatives that drive measurable improvements in product reliability, customer satisfaction, and engineering efficiency. How will you make an impact? Serve as the quality leader for an entire domain and be accountable for the product quality Actively track the domain's quality tasks, analyze the testing needs, and define QA activities and ownership Continuously analyze and challenge existing testing coverage Plan, develop, and oversee execution of test strategy across domain Lead Quality assurance efforts that align with product objectives to ship products rapidly and with confidence Define and communicate strategic quality KPIs; monitor and act on insights to drive continuous improvement. Ensure quality is embedded throughout the SDLC, from planning and requirements to deployment, through clear acceptance criteria, regression impact analysis, and automated testing practices. Standardize, implement and evolve QA processes to get effective test coverage and scale testing efforts across our products Partner with product, engineering and DevOps teams to leverage automation for scalable solutions to prevent regression defects and ensure reliability of product Plan and lead NFR testing Define guidelines and quality led best practices for our engineering groups Coordinate cross-organization/cross-region testing activities Mentor and guide QA leaders and engineering managers to foster a culture of ownership, accountability, and continuous improvement in quality. Have you got what it takes? Education: BSc in Computer Science/Software Engineering or equivalent Requirements Minimum 3 years QA leadership experience: Team leader/Manager Minimum 5 years of Experience as a QA engineer with at least 4 years of automation experience Extensive experience designing tests for an enterprise SW solution Leadership, coordination abilities and the ability to influence without authority Ability to define QA processes across development groups Hands on experience with CI/CD and Test-Driven Development Excellent communication skills (written and verbal) and interpersonal skills Experience with full software development lifecycle using Agile Development methodology Superior analytical and problem-solving abilities Strong self-motivation; Excellent work ethic, dependable and responsible What's in it for you? This is a high-impact leadership role for someone passionate about driving quality at scale, influencing engineering culture, and delivering exceptional customer experiences. Join an ever-growing, market disrupting, global company where the teams - comprised of the best of the best - work in a fast-paced, collaborative, and creative environment! As the market leader, every day at NICE is a chance to learn and grow, and there are endless internal career opportunities across multiple roles, disciplines, domains, and locations. If you are passionate, innovative, and excited to constantly raise the bar, you may just be our next NICEr! About NiCE NICE Ltd. (NASDAQ: NICE) software products are used by 25,000+ global businesses, including 85 of the Fortune 100 corporations, to deliver extraordinary customer experiences, fight financial crime and ensure public safety. Every day, NiCE software manages more than 120 million customer interactions and monitors 3+ billion financial transactions. Known as an innovation powerhouse that excels in AI, cloud and digital, NiCE is consistently recognized as the market leader in its domains, with over 8,500 employees across 30+ countries. NiCE is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, age, sex, marital status, ancestry, neurotype, physical or mental disability, veteran status, gender identity, sexual orientation or any other category protected by law.

Posted 2 weeks ago

AI QA & Infrastructure Engineer-logo
AI QA & Infrastructure Engineer
AidalySan Francisco, California
Description About Aidaly At Aidaly, we believe family caregivers are the future of healthcare and the backbone of a thriving economy. In-home care is the fastest-growing part of healthcare, but demand is outpacing supply. We are pioneering a new model for delivering care at home by training and paying family caregivers to meet the needs of an evolving population and changing workforce. We are scaling rapidly across the United States. Join us! What You'll Do Design and execute manual and automated test plans across Aidaly’s web, mobile, and AI-driven products. Develop test cases, regression tests, and bug tracking workflows to proactively catch issues before launch. Test AI-assisted features (e.g., dynamic caregiver communications, automated documentation flows) for accuracy, relevance, and experience quality. Create and maintain testing environments that simulate real-world caregiver and ops team behaviors. Identify root causes of issues quickly and collaborate with Product and Engineering to drive resolutions. Define and track quality metrics , creating a feedback loop to improve system reliability and caregiver experience. Participate actively in sprint planning and product reviews , serving as a champion for testing, quality, and user empathy. Continuously improve QA processes by recommending and implementing new tools, frameworks, and automation methods. Requirements Who You Are 3–5 years experience in software quality assurance, QA engineering, or equivalent roles. Strong manual testing skills with a demonstrated interest in growing automated test coverage. Familiar with QA tools and frameworks such as Selenium, Cypress, Playwright, or equivalent. Deep understanding of AI/ML systems or experience testing non-deterministic outputs (bonus if you’ve worked with LLMs, AI APIs, or recommendation systems). Analytical, detail-oriented, and passionate about building seamless user experiences. Exceptional communicator — able to write clear bug reports, escalate effectively, and advocate for users internally. Comfortable in fast-paced, ambiguous startup environments where priorities evolve rapidly. Mission-driven: excited to build tools that improve lives for families and caregivers. If you're the type of person people naturally depend on for support; honest, consistent, calm under pressure, and solution-focused - WE WANT YOU! Benefits What We Offer Competitive salary + performance bonuses based on KPIs. Health, dental, and vision insurance. Paid time off and holidays. 401K (starting Q3 2025) High-autonomy, high-impact role — true domain ownership. Quarterly off-sites, trainings, and team building experiences. Opportunity to build something transformative for millions of American families.

Posted 3 weeks ago

QA Automation Team Lead-logo
QA Automation Team Lead
UlinePleasant Prairie, Wisconsin
QA Automation Team Lead Pay from $121,000 to $150,000 per year Corporate Headquarters 12575 Uline Drive, Pleasant Prairie, WI 53158 Drive quality and innovation as Uline’s Quality Assurance Automation Team Lead. Guide and support your team to implement automated testing solutions and deliver top-tier applications for our growing company! Careers Packed with Potential. Backed by 45+ years of success, Uline offers opportunities to grow your career with stability you can count on. Position Responsibilities Manage a team of QA analysts, fostering strong collaboration and driving high performance. Represent Test Automation to QA and IT leadership, ensuring alignment with organizational goals. Prioritize and assign QA work and assignments. Balance strategic oversight with hands-on testing to ensure quality and efficiency. Implement best practices, policies and procedures to optimize QA processes. Track and report quality metrics, ensuring continuous improvement and accountability. Minimum Requirements Bachelor's Degree in Information Technology, Computer Science or a related field. 8+ years of experience in QA automation, with 3+ years in a leadership or mentoring capacity. Strong expertise in automated test frameworks such as Playwright, Cypress, Selenium, REST-assured, etc. Experience programming with a modern language such as JavaScript, Typescript or Python. Strong understanding of SQL, API testing and Agile. Benefits Complete health insurance coverage and 401(k) with 6% employer match that starts day one ! Multiple bonus programs. Paid holidays and generous paid time off. Tuition Assistance Program that covers professional continuing education. Employee Perks On-site café and first-class fitness center with complimentary personal trainers. Over four miles of beautifully maintained walking trails. About Uline Uline, a family-owned company, is North America’s leading distributor of shipping, industrial, and packaging materials with over 9,000 employees across 14 locations. Uline is a drug-free workplace . All positions are on-site. EEO/AA Employer/Vet/Disabled #LI-MT1 #CORP (#IN-PPITL1) Our employees make the difference and we are committed to offering exceptional benefits and perks! Explore Uline.jobs to learn more!

Posted 1 day ago

QA/Scrum Master-logo
QA/Scrum Master
AHU TechnologiesWashington, District of Columbia
6-10 yrs. Software Development Lifecycle experience 6-10 yrs. MS Office/PowerPoint experience Experience communicating effectively in a professional setting both written and verbally (including presentations) Bachelor’s degree in IT or related field or equivalent experience Overall QA Experience Overall Training Experience Requirements gathering and documentation Scrum Product Owner Accredited Certification International Institute SAFe Scrum Master 5.0 Scaled Agile Experience acting as Scrum Master Experience acting as QA lead or Manger Tableau Server Administration and Report Development experience PL/SQL Work remote temporarily due to COVID-19. Compensation: $42.00 - $52.00 per hour About Us AHU Technologies INC. is an IT consulting and permanent staffing firm that meets and exceeds the evolving IT service needs of leading corporations within the United States. We have been providing IT solutions to customers from different industry sectors, helping them control costs and release internal resources to focus on strategic issues. AHU Technologies INC. was co-founded by visionary young techno-commercial entrepreneurs who remain as our principal consultants. Maintaining working relationships with a cadre of other highly skilled independent consultants, we have a growing number of resources available for development projects. We are currently working on Various projects such as media entertainment, ERP Solutions, data warehousing, Web Applications, Telecommunications and medical to our clients all over the world.

Posted 4 days ago

QA Operations Manager (FULLY ONSITE)-logo
QA Operations Manager (FULLY ONSITE)
Thermo Fisher ScientificHigh Point, North Carolina
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Excellent Benefits Package Review our company’s Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 6% Tuition Reimbursement – eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Location Information: High Point, NC Click here for site video: High Point Softgels Responsibilities Aide in the release of products by resolving CAPA, Change Management, and deviation/OOS compliance issues. Support the plant during regulatory inspections. Ensure the Quality Management System (QMS) is followed at High Point through SOP operational adherence. Leads and manages the DEA program for the site. Lead cross-functional teams in quality/compliance improvement activities. Serve as the primary technical subject matter expert for troubleshooting, problem-solving, and operational quality assurance. Ability to apply sophisticated technical and organizational problem-solving methodologies. Identify negative quality/compliance trends and determine root causes for correction. Assist in assigning appropriate corrective and preventative actions. Maintain up-to-date knowledge of global regulations and quality standards. Review and approve various operational documentation requiring QA oversight. Drive the implementation and improvement of global and regulatory policies and procedures to meet regulatory and customer expectations. Establish collaborative relationships with operations and support group leaders. Manage and develop Quality Assurance Engineers and Data Review teams. Qualifications BS degree with 6-8 years of GMP experience within the pharmaceutical or medical device industries. Proven ability to independently prioritize multiple projects. Excellent communication skills for presenting information to senior management and public groups. Advanced proficiency in statistical analysis and problem-solving tools. Ability to meet DEA security clearance requirements. We value your experience and perspective, and together we will successfully implement strategies that maintain our competitive edge. Apply your skills and be part of our mission to make the world healthier, cleaner, and safer!

Posted 2 days ago

QA Inspector-logo
QA Inspector
CatalentPhiladelphia, Pennsylvania
Quality Assurance Inspector 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. This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities. Catalent Pharma Solutions in Philadelphia is hiring a Quality Assurance Inspector. The Quality Assurance Inspector reports to the Quality Supervisor. The Quality Inspector is responsible for process monitoring and auditing of packaging operations, the duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, and supporting actions (if required) for resolution of deviations and investigations. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time’ performance of the operation and will manage those opportunities to implementation and improvement, in partnership with Production personnel. This is a full-time role position: Monday-Friday: 7:45am-4:15pm. Hourly, Onsite 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 ensuring that Standard Operating Procedures are consistently followed, and that cGMP’s are observed, in the course of incoming inspection, distribution, label control, destruction and returns. This may require simultaneous auditing and/or monitoring of one or more processes. This role can support both Commercial and Clinical Operations Verifies and inspects incoming materials and works accordingly with Quality and Project Management to handle any possible discrepancies Perform inspection and release of all clinical and commercial drug products and components received from customer or vendor as per customer specifications protocols and/or Catalent SOPs, includes review of all inventory labels applied to the containers and paperwork generated from JDE with receipt paperwork Perform inspection and release of all shipping and distribution materials to clinical sites or clients by reviewing all associated paperwork and picked material, including verification of each individual randomized container and compliance with customer specific distribution protocols Perform inspection and release of materials slated for destruction, by reviewing the associated paperwork and picked materials. Inspect and release of clinical open, randomized, single panel booklet and multi language labels produced by external vendors and Clinical Supply Services by comparison to approved label proof or label copy request Reviews BMS system printouts and chart recorder printouts for out of specification temperatures, humidity and pressures. Inspect retain samples, as required. Maintains & provides departmental metrics. Assists in walk through audits of the Supply Chain facility, Label control room, Refrigerator/Freezer and associated areas to ensure cGMPs and SOPs are being followed Reviews Supply Chain Facility logbooks, Label Room logbooks, Pest Control logbooks and Sampling Room logbooks for GMP compliance and revises SOPs as needed Partners with other departments in resolving unplanned deviations, investigations, in troubleshooting, and in process improvements. Performs additional sampling/testing protocols on clinical trial materials as requested by the customer. Participate in customer audits when required. Complete & maintain documentation Performs other duties or tasks as requested or required by QA Management. All other duties as assigned; The Candidate Requires a Bachelor’s Degree or a minimum of five years of Production/ Quality Assurance experience. Proven track record of monitoring/auditing for quality assurance and/or identifying potential efficiencies in a production environment preferred. Experience in a regulated field preferred – pharma, food, automotive, etc. Good Computer Skills. Knowledge of MS Office and Inventory Management system are a plus. Basic knowledge of Lean Six Sigma methodologies an advantage Good knowledge of the application of FDA cGMP’s. Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds Occasional requirement to work in cold environment to fill orders (walk-in refrigerator/freezer) Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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 1 day ago

Electrical QA Supervisor (On-site) - Indianapolis, Indiana-logo
Electrical QA Supervisor (On-site) - Indianapolis, Indiana
Decima InternationalIndianapolis, Indiana
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. 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 Electrical QA Manager to support the development of multiple hyperscale data center projects for one of our top technology clients. This is a client-facing role that requires strong interpersonal, communication, and organizational skills; the ability to self-direct; effective client representation; and a strong foundation in project management fundamentals. The ideal candidate must be able to manage multiple projects concurrently. A strong background in data center development, design, engineering, controls, and operational requirements is a significant plus. You will play an integral role in developing and implementing the Quality Management System (QMS), as well as coordinating, performing, and completing all construction audits and commissioning services related to the project. The Electrical QA Manager is accountable for the quality of work performed, compliance with building codes and safety regulations, and for meeting the project’s contractual requirements as set forth by the client. We’re seeking dedicated individuals with a passion for innovation and the ability to multitask 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 Understand project scope and requirements Ensure compliance with quality standards, building codes, safety regulations, and environmental guidelines Review and verify material submittals for A/E and client approval Confirm that delivered materials match approved submittals Manage and review submittals, RFI logs, maintenance logs, and other project documentation in a timely manner Update QC punch lists and coordinate with general contractors (GCs) and subcontractors for completion Conduct internal quality audits and on-site inspections Adhere to Quality, Health, Safety & Environment (HSE) standards Provide technical support to address operational challenges and client concerns Plan and inspect Definable Features of Work (DFWs) Develop and implement audit and test plans for quality inspections and testing Maintain and update quality manuals, checklists, and forms Collaborate with third-party QA/QC firms as needed Participate in Quality Management System (QMS) audits Build and maintain relationships with project partners, consulting engineering firms, public agencies, and clients Ensure document control compliance and maintain project submittal logs and quality control reports Verify and document material compliance with approved submittals Compile and submit project closeout documents, including O&M manuals, as-builts, and warranties Investigate and resolve non-conformance issues promptly Ensure timely calibration of inspection, measurement, and test equipment Liaise with the General Contractor, Client, and Project Management team to resolve quality issues Prepare and present reports on progress, findings, and recommendations to management Review subcontractor submittals for compliance Coordinate and monitor subcontractors, suppliers, direct labor, and materials Collaborate with utility suppliers for final service connections Coordinate activities with inspection agencies Complete required MEPS and electromechanical inspections Assist in preparing periodic QA/inspection progress reports Review and approve subcontractor work completion percentages Oversee commissioning processes Manage MEP project closeout to ensure all requirements are met QUALIFICATIONS Required Qualifications: 12+ years of construction and quality management experience Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a related field Prior experience with hyperscale data center development and construction Experience managing field engineering, inspection, and NDE for QA/QC functions Proficient in reading and interpreting plans, specifications, drawings, contracts, and documents related to MEP scopes Ability to develop and manage non-conformance and defect tracking programs, including root cause analysis Deep understanding of codes, standards, job specifications, project procedures, and applicable regulations Ability to thrive in high-production environments and under tight deadlines Strong technical knowledge of materials and construction practices Experience as an Electrical QA/QC Supervisor for large commercial, industrial, or mission-critical construction projects Excellent knowledge of construction Quality Management Systems (QMS) Familiarity with punch list and project closeout procedures Excellent attention to detail and strong analytical skills In-depth knowledge of high-, medium-, and low-voltage systems, HVAC, control systems, commissioning, LEED/green building standards, and general ground-up construction as they relate to MEPS Preferred Qualifications: Project Management Professional (PMP) certification Construction Quality Manager Certification (CQMC) U.S. Army Corps of Engineers (USACE) QA experience Certified Quality Auditor (CQA) Member of the American Society for Quality (ASQ) Six Sigma certification ISO 9001 experience Green Business Certification (LEED) POSITION DETAILS Location (On-site): Indianapolis, Indiana Position: Electrical QA Manager Classification: Salary-based, full-time, regular hours Current U.S. work permit required. This position does not offer employment sponsorship (e.g., H-1B visa sponsorship or transfer is not offered). PRODUCTIVITY TOOLS Microsoft Office Microsoft 365 CxAlloy Job Type: Full-time Schedule: 8-hour shift Work Location: (On-site) Indianapolis, Indiana 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 weeks ago

QA Technician (Nights)-logo
QA Technician (Nights)
Nature's BakerySalt Lake, Utah
Shift: 2-2-3 rotating schedule Nights 6am-6pm Quality Assurance Food Technician SUMMARY Monitors all quality assurance/food safety activities and makes recommendations and carries out corrections for improving Quality departmental functions. Knowledge of food quality standards and procedures is vital and good attention to detail, strong communication skills & logical thinking. Tests and inspects products at various stages of production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products by performing the following duties. ESSENTIAL DUTIES AND RESPONSIBILITIES Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Perform related duties and provides support to the Quality Assurance Management. Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change. Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. Performs tests at specified stages in the production process, and tests products for a variety of qualities such as temperature, defects, code dates, etc., records results, reviews records, and reports for accuracy and completion. Evaluates data and writes reports to validate or indicate deviations from existing standards. Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability. Completes special projects assigned, work with the project team; help to resolve problems by examining and evaluating data; selecting corrective steps. Quality analysis of incoming dry goods for production. Verification of specifications before startup and throughout production processes. Problem solving on quality issues with production and other teams. Documentation of key metrics for data analysis. Maintenance of calibration and logs of all laboratory instruments. Preparation of laboratory equipment and solutions. Direct communication with operators and production personnel. General analysis and sampling of production samples. Collection of retention samples on shiftily basis. QUALIFICATIONS: - 1 year + Experience in a Quality Assurance or food Safety role within a manufacturing facility LANGUAGE SKILLS Ability to read and interpret quality documents, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups. MATHEMATICAL SKILLS Ability to apply mathematical operations and concepts to solving quality process-related problems.. 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. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; sit; use hands, handle, or feel; and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, outside weather conditions, and energized equipment. The noise level in the work environment varies depending on tasks. OTHER DUTIES Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. EEO We are committed to an inclusive workplace where diversity in all its forms is championed. We are proud to be an equal opportunity workplace and we are an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Privacy Policy Mars and its family of brands is committed to transparency and responsibility in how we handle the personal data entrusted to us by our customers and consumers. To learn more about our privacy policy please follow this link .

Posted 30+ days ago

QA Manager, Quality on the Floor-logo
QA Manager, Quality on the Floor
Thermo Fisher ScientificGreenville, North Carolina
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description How will you make an impact? With a strong dedication to customer happiness, you’ll provide technical leadership and Quality oversight for our Solid Dose/Animal Health Manufacturing and Sterile Manufacturing Environments in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. You will responsible for driving strong Customer Happiness by ensuring compliance. What you will do: Manage the quality on the floor team supporting quality oversight of the operational areas within Thermo Fisher Scientific. Review and approve quality records such as investigations, protocols, and procedures. Handle the functions and staff, to assure the products, processes, and records align with company specifications, legal agreements, and applicable regulations as a requirement for release to license holder and/or market. Provide tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules. Provide direct supervision and may assist with the work as demands dictate. Provide leadership to assigned staff by performing the following: • Leading organizational change. • Developing and empowering staff. • Encouraging relationships. • Putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals. • Building effective teams that apply their diverse skills and perspectives to achieve common goals. • Driving engagement and crafting a climate where staff is motivated to do their best. Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. Ensure quality of methods, processes, and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes. Follow all job-related safety and other training requirements in a timely manner. Support systems and new product introduction as a technical resource by providing assessment technical expertise, problem solving, and strategies for problem prevention. Develop strategies and priorities to assure future success of the Company. Conduct quality risk assessments, and takes appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety, and business risks. Manage resources by budgeting for and assuring availability of staff to meet business needs. Maintain current knowledge of emerging trends and technologies. Ensure staff has performance plans with metrics in place. Review are conducted twice a year (mid-year and annually). Identify and manage performance/team issues. Provide training and/or opportunities for career development of staff. How you will get here: Education: Bachelor's Degree in a scientific or related field highly preferred or an equivalent combination of education, training, and relevant work experience may be considered. Experience: 7 years of experience in the pharmaceutical industry that includes 5 years supervisory experience. Project Management skills desired. Superior cGMP experience and leadership required. Deep knowledge of cGMPs and pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs. Advanced problem-solving skills and comfortable working directly with our valued customers to identify solutions. Strong communication, persuasion, and presentation skills. Advanced change management skills are vital. Must be able to interact with and influence the most senior levels of the organization. PHYSICAL REQUIREMENTS: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. 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 global organization of 120,000+ 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 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.

Posted 1 week ago

QA Manager-logo
QA Manager
Eastern Shipbuilding GroupPanama City, Florida
This job description is a general description of the essential job functions and is not intended to be an employment contract. Eastern Shipbuilding Group, Inc. maintains its status as an at-will employer. Position requirements, skills, and abilities included in this job description have been determined to be the minimal standards required to successfully perform the position. Eastern Shipbuilding Group Inc. reserves the right to increase, waive or reduce these minimal standards. In no instance, however, should the duties, responsibilities, and requirements described be interpreted as all-inclusive. All employees of Eastern Shipbuilding Group, Inc. are expected to perform the duties as assigned by Eastern Shipbuilding Group, Inc., supervisory/management personnel, regardless of job title or routine job duties. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. To perform this job successfully, an individual is expected to be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability expected. In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. However, no accommodation will be made which may pose serious health or safety risks to the employee or others or which imposes undue hardship on Eastern Shipbuilding. POSITION SUMMARY Supervise the activities of the Quality Assurance Dept. Has overall responsibility for the processes needed for the Quality Management System (QMS) to function and ensure they are established, implemented and maintained. ESSENTIAL DUTIES AND RESPONSIBILITIES MAY INCLUDE THE FOLLOWING: Because Eastern Shipbuilding is continually growing to meet the needs of our customers; your duties and responsibilities may be different than described. Regular attendance at work and the ability to work flexible hours, including overtime, weekends, and holidays. Comply with Company, federal, state, and local safety, ethics, and environmental rules, regulations and policies while performing duties. Reports to top management on the performance of the QMS and any need for improvement. Ensure the QMS conforms to customer requirements. Promotes the awareness of customer requirements throughout the organization. Ensure the quality records are established and maintained to provide evidence that the QMS is being followed. Oversee inspection teams to ensure high productivity and technical integrity. Coordinate production building managers and customer inspection teams. Provide technical assistance and expertise to QA Inspectors. Create, document and implement inspection criteria and procedures. Maintain an active role in internal continuous improvement. Investigate and correct deficiencies related to customer requirements, specifications, and Company standards. Coordinate production activities to meet the quality standards. Ensure all inspections and tests are complete and meet customer requirements. Maintain welder performance qualification records. Develop, implement and maintain welding procedures specifications. Perform additional duties as assigned. SUPERVISORY RESPONSIBILITIES Directly and/or indirectly supervise employees assigned to the QA Dept. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work. Travel is primarily local during the business day, although some out-of-area and overnight travel may be required. REQUIREMENTS Education/Experience : Bachelor’s degree in marine engineering, Quality Assurance or a related field plus eight to ten years’ experience in ship construction. Three to five years supervisory experience desired. An equivalent combination of education and experience may be considered. Must be able to manage a team of highly skilled inspectors efficiently, effectively, and safely. Requires knowledge of shipbuilding terminology, Occupational Safety and Health Administration (OSHA) standards, U.S. Coast Guard classification rules and shipbuilding standards. Extensive knowledge of shipbuilding production processes and methods preferred. Skills : Intermediate level Microsoft Word, Excel, and Outlook Express. Ability to read and comprehend written technical specifications, drawings, blueprints and schematics. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to effectively present information and respond to questions from supervisors and employees. Ability to establish and maintain effective working relationships and preserve interdepartmental relationships. Ability to add, subtract, multiply, and divide in all units of measure. Behavioral Attributes : Integrity, ethics, flexibility/adaptability, initiative, interpersonal skills, attention to detail, safety conscious, and multi-tasking. Maintain the confidential integrity of details pertaining to Eastern Shipbuilding Group. Certificates, Licenses, Registrations: Ability to obtain and maintain a valid drivers’ license . PHYSICAL DEMANDS While performing the duties of this job, the employee is regularly required to communicate. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing throughout the workday. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The employee must be physically and medically qualified to wear all required personal protective equipment, as prescribed under Occupational Safety and Health Administration (OSHA) standards. The employee must be able to work above ground at heights of a minimum of 50 feet aloft and/or working from scaffolding and/or man-lifts while working with machinery; in confined spaces and withstand extreme heat and cold in an outside climate or confined space. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee may be exposed to the risk of electrical shock, moving mechanical parts, vibration, fumes, airborne particles, toxic or caustic chemicals, continual loud noise, and other hazards found in a heavy industrial shipyard environment. Rigorous compliance with safety procedures, policies, and personal safety equipment requirements is therefore mandatory. We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

Posted 3 days ago

QA Supervisor, Quality on the Floor (12-hour days)-logo
QA Supervisor, Quality on the Floor (12-hour days)
Thermo Fisher ScientificGreenville, North Carolina
Work Schedule 12 hr 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 POSITION SUMMARY This QA Supervisor is responsible for quality assurance of sterile operations with respect to manufacturing, filling, packaging and inspection, and associated non batch specific activities in the Sterile facility for both commercial and product development services products. Oversight by the Quality "On the Floor" team provides quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours would be 6a - 6p on a 2-2-3 rotation. Key Responsibilities: Supervise a small team of QA professionals. Lead self and others with respect to: (1) job performance and employee development planning and execution, (2) QA standard work execution and collaboration with other departments to meet quality system objectives, (3) quality system decision making and risk mitigation, and (4) follow procedures while providing sound QA decisions and/or recommendations. Perform daily assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs. Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique. Champions quality culture by aiding personnel in understanding application of policies and controls. Participate in rapid response and provides quality guidance and decision making for RAPID events. Advance deviation events to the appropriate area and quality management Perform quality review and approval of procedures, training documents, and forms, as well as deviation and change control. Participate as QA representative in root cause analysis to support deviation investigations. Perform batch record review. Qualifications: Associate’s degree in science, technology, engineering, mathematics (STEM) or business is minimally required. A Bachelor's degree in those fields is highly preferred 3+ years of experience in Quality Assurance, Quality control or Operations/Manufacturing 1+ years of experience in a leadership function Previous experience in pharmaceutical industry or cGMP environment required, preferably in aseptic or sterile processes. Knowledge, Skills, Abilities: Ability to make decisions while taking into account level of risks in regard to compliance and product quality. Ability to gather data, analyze & troubleshoot process issues, equipment problems along with production leadership. Outstanding attention to detail and organizational skills. Hard-Working, demonstrated ownership & responsibility; Ability to lead, support & motivate a team. Ability to work in a fast-paced environment, able to multi-task and results oriented. Effective time management and prioritization skills. Requires discretion and independent judgment. Technical writing skills knowledge. Excellent interpersonal skills, including tact to handle sensitive matters. Highly effective verbal and written communication skills. Professional certifications (ex: CQA) and training (Six Sigma) are a plus. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally. What We Offer 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! Compensation Competitive Pay Annual performance-based bonus Annual merit performance-based increase Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays 401K Tuition Reimbursement Employee Referral Bonus Career Advancement Opportunities 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

Posted 1 week ago

QA Engineer-logo
QA Engineer
WaystarLouisville, Kentucky
ABOUT THIS POSITION Waystar is looking for a strong team member who is passionate about delivering quality products to our clients. As a QA Engineer, you will develop, implement, and execute test cases to ensure our software functionality meets the highest standards of quality before going to production. We work in a fast-paced, collaborative, and fun environment, and are seeking a QA Engineer who can not only bring experience to the team but can also explore and learn new and interesting ways for us to efficiently test our products. WHAT YOU'LL DO Define, develop, and implement quality assurance best practices and procedures, test plans and other QA assessments Design and execute manual and automated testing systems using commercial tools, scripts, and data sets Assist in maintaining and updating the current library of automated tests Assist with test automation efforts by writing automated tests and analyzing results of automated tests Enforce processes that improve the quality of Waystar software solutions Maintain production quality by measuring and monitoring key performance indicators Work in cross-functional teams to deliver quality test plans that meet defined requirements Execute test cases and document defects Review test results to assure quality of existing and new functionality Certify code deployments meet Waystar requirements WHAT YOU'LL NEED Strong troubleshooting and logic skills Attention to detail with a strong commitment to quality Strong communication skills Comfortable with cross-functional collaboration Ability to learn complex subjects quickly 2+ years of experience in a QA Engineering role Experience working with C#, or similar programming language and comfort with extensive XML/JSON work (Playwright) Experience testing Web applications built around web services Strong database design and query writing skills – using SQL Server required Bachelor's degree in computer science or similar technical/quantitative field preferred Familiarity with ADO, Jenkins, Github Actions, etc ABOUT WAYSTAR Through a smart platform and better experience, Waystar helps providers simplify healthcare payments and yield powerful results throughout the complete revenue cycle. Waystar’s healthcare payments platform combines innovative, cloud-based technology, robust data, and unparalleled client support to streamline workflows and improve financials so providers can focus on what matters most: their patients and communities. Waystar is trusted by 1M+ providers, 1K+ hospitals and health systems, and is connected to over 5K commercial and Medicaid/Medicare payers. We are deeply committed to living out our organizational values: honesty; kindness; passion; curiosity; fanatical focus; best work, always; making it happen; and joyful, optimistic & fun. Waystar products have won multiple Best in KLAS® or Category Leader awards since 2010 and earned multiple #1 rankings from Black Book™ surveys since 2012. The Waystar platform supports more than 500,000 providers, 1,000 health systems and hospitals, and 5,000 payers and health plans. For more information, visit waystar.com or follow @Waystar on Twitter. WAYSTAR PERKS Competitive total rewards (base salary + bonus, if applicable) Customizable benefits package (3 medical plans with Health Saving Account company match) We offer generous paid time off for our non-exempt team members, starting with 3 weeks + 13 paid holidays, including 2 personal floating holidays. We also offer flexible time off for our exempt team members + 13 paid holidays Paid parental leave (including maternity + paternity leave) Education assistance opportunities and free LinkedIn Learning access Free mental health and family planning programs, including adoption assistance and fertility support 401(K) program with company match Pet insurance Employee resource groups Waystar is proud to be an equal opportunity workplace. We celebrate, value, and support diversity and inclusion. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, marital status, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Posted 2 weeks ago

QA Specialist-logo
QA Specialist
Globus MedicalSan Antonio, Texas
Bone Bank Allografts, a subsidiary of Globus Medical Inc., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus’ renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution. The Position Summary: The Quality Assurance Specialist works within the Quality Department to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the QA Specialist is to provide review and release of product records to ensure compliance to company procedure and applicable federal, state, local, and accreditation standards. Essential Functions: Perform data entry review and release ensuring entry of finished goods coincides with the Distribution software Perform secondary review of Donor Processing Records for terminally sterilized and aseptic lines Coordinate with the QA Systems Team Lead or Management to prioritize product release Perform release functions to finished goods Review test reports as part of release criteria Review technical and performance specifications Review irradiation shipment documents for acceptability Verify domestic or international requirements for product release Investigate and track status of records pending release Assist in onboarding new private label clients by verifying label requirements prior to use Assist Distribution department with the review and release of re-designated products as requested Perform Quality review of assigned records or logs and verify procedure requirements were met for approval and closure of the records Maintain error spreadsheets and create graphs/trending reports as needed Assist with performing the monthly inventory of QA product Report non-conformances and discrepancies. Participate in continuous improvement initiatives and implementations. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications: Bachelor’s degree preferred. Experience performing file reviews and/or audits. QA or QC experience within the biotech/tissue banking industry preferred. Knowledge of GMP regulations preferred Must be knowledgeable with Microsoft Word and Excel programs. Strong typing skills, analytical skills, and problem solving techniques. Excellent communication and writing skills. Physical Demands : The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Required to sit; climb or balance; and stoop, kneel, crouch or crawl Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus Our Values : Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven. Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate about our role in improving the lives of patients by continuously developing better solutions. Customer Focused : We listen to our customers’ needs and respond with a sense of urgency. Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger. Driven : We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. Equal Employment Opportunity : Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. Other Duties : Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Posted 3 weeks ago

QA Inspector (11pm-7:30am)-logo
QA Inspector (11pm-7:30am)
American RegentShirley, New York
Nature and Scope This position is responsible for providing Quality oversight in manufacturing areas including, but not limited to Formulation, Filling, Inspection, Equipment Prep and Packaging through the execution of site policies and procedures, programs, and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. The QA Inspector maintains compliance with quality programs. Essential Duties and Responsibilities All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134) Drug product inspection. Achieve and maintain Aseptic Processing Area (APA) gown qualification. Adhere to all SOP related to working in an aseptic environment, including volume/weight checks of product filled in vials and ampoules; s well as the monitoring of personnel Aseptic Technique. Checks product lot number information, documents in the batch record where applicable, and reviews Master Batch Records for accuracy at all stages in the manufacturing process - Formulation, Filling, Inspection, and Packaging. Conducts product in-process inspections at designated intervals. Determines the Acceptable Quality Limits (AQL) by using the (American Nation Standards Institute) ANSI Z1.4 Standard Inspectors Rule, the ruler assists with the calculation of sample size and Accept/Reject (A/R) numbers. Conducts inspection of formulation equipment (e.g. tanks) for cleanliness, imperfections, and acceptable operating condition. Documents verification of task performed (where applicable). Conducts visual inspection of filled vials and ampoules after manual or automated inspection for defined critical major and minor defects, as well as particulate matter. Conducts inspection of printed materials (e.g. labels), inserts, finished units, unit packs, and shipping containers for critical major and minor defects. Perform monthly inspection of the retentions samples to ensure quality of finished products until expiration. Assist in the management of the sample retention room (removing samples for monthly inspections, putting away samples from monthly inspections, adding new samples to the room, and removing samples from the room that have expired). Reports all non-conformances to supervision. Education Requirements and Qualifications High School Diploma or GED equivalent, required. 1 year of related experience in Quality Assurance and/or manufacturing within a cGMP environment, preferred. Experience in a pharmaceutical, biotech, food, or related manufacturing environment, preferred. Working knowledge of good manufacturing systems, familiarity with regulatory and manufacturing SOPs and cGMPs, preferred. Ability to perform accurate mathematical calculations, required. Basic computer skills including Microsoft Outlook, Word, Excel, required. Strong attention to detail, adherence to SOPs, and a desire for ensuring a high-quality product. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to meet and maintain sterile gowning requirements. Ability to work overtime as needed, including weekends when required. Physical Environment and Requirements Employee must be able to occasionally lift and/or move up to 25 pounds. Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Expected Hourly Rate: $23.61-$25.00 The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal ( eeoc.gov ) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com .

Posted 3 weeks ago

RN QA homecare and or hospice must have experience-logo
RN QA homecare and or hospice must have experience
University Home CareLivonia, Michigan
University Home Care is looking for a skilled Registered Nurse with Quality Assurance experience in the homecare and/or hospice setting to join our team in Livonia, MI. Conduct quality assurance checks on patient care plans and documentation. Ensure compliance with all regulatory requirements. Develop and implement quality improvement initiatives. Provide training to staff on quality assurance measures. Active RN license in the state of Michigan. Prior experience in Quality Assurance in homecare and/or hospice. Strong knowledge of regulatory requirements in homecare/hospice. Excellent communication and organizational skills. Competitive salary. Health and dental insurance. Paid time off. 401(k) retirement plan. University Home Care is a leading provider of homecare services in the Livonia, MI area. We are committed to providing high-quality care to our patients and ensuring a positive work environment for our employees. We have 2 positions available.One position that is full-time.Salary requires you to visit patients in the field for home care.Ann hospice in Wayne, Oakland and mccombnaughey's.The other position is for part time contractor

Posted 30+ days ago

I
Senior QA Validation Specialist
Immatics USHouston, Texas
J oin Immatics and shape the future of cancer immunotherapy ; one patient at a time! Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Senior Quality Assurance Validation Specialist to support our Quality Assurance Validation team. The Senior Quality Assurance Validation Specialist will be a Subject Matter Expert in quality matters in the biopharmaceutical industry: this role serves as on-site QA representative in the U.S. based QA Validation team to handle commissioning, qualification and validation (CQV) activities. Specialist support covers multiple aspects in the Validation Lifecycle Management System (VLMS) from clinical phase toward commercialization including but not limited to quality oversight in equipment validation, analytical method validation and manufacturing process validation. FLSA Classification : Salary/ Exempt Schedule : 8:00 AM – 5:00 PM; Monday to Friday; On-site (Overtime hours on a business need basis) Reports to : Manager, QA Validation Location : 13203 Murphy Road Suite 100 Stafford, TX 77477 What You’ll Do: As a Senior Quality Assurance Validation Specialist, you will play a key role in supporting our validation operations: QA Review of validation documents including User Requirement Specifications, Design Verifications, Risk Assessments, Validation Plans, Qualification Protocols, Validation Reports. Quickly recognize, implement, and enforce compliance with applicable regulations, Propose best practices based on industry standards & guidance as well as state-of-the-art in the field of Cell Therapy (e.g. Adoptive Cell Therapy). Facilitate cross-functional teamwork with workstream’s stakeholders including harmonization and alignment of own QA Validation deliverables with U.S. QA Validation Management, Global Quality Operations and cross-functional Leadership. QA review representative for pre- and post-execution deliverables of validation related documents which may focus on company’s assets such as computerized systems, production process equipment, laboratory method studies, facilities and IT infrastructure in scope for GxP matters. Review Procedures such as Operational, Maintenance Cleaning documents (OMC) with focus on quality requirements and good documentation practices. Review deliverables from Quality Management Systems under VLMS, Change Control and Audits. Supports Project Management with Quality focus, Data Management, Digitalization initiatives, Business Continuity and Archival Business Processes. Secondary Functions: Secondary functions, ad-hoc or in case of need as directed by line manager, QA Validation: Support the Operational Quality Assurance Systems organization. Support Quality initiatives. Support Operational Excellence and Lean concepts Required Experience and Education: At least 4 + years' experience in a related role Batchelor's degree in Computer Science, Life Sciences, or Engineering Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility). Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines. Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point. Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings. Advanced understanding of CQV and Lifecycle Pillars, which may include equipment/asset lifecycle management, equipment qualification execution, equipment operation, equipment maintenance, workflows incl. GxP Computerized System Validation (CSV), Qualification phases such as IQ, OQ, PQ, process validation, method validation and facility’s commissioning & qualification. Intermediate to Advanced regulatory and auditing understandin g. Intermediate to Advanced r egulatory filing understanding with U.S. FDA such as Biologics License Application (BLA) . Intermediate to Advanced project management or peer coaching/training experience showing organizational and interpersonal skills. E xperience with cell-based production processes, cell-based and molecular-based analytical testing in the field of Cell and Gene Therapy including cell production, cell handling & maintenance, cell quantification, viral vector and nucleic acid quantitation or detection ( e.g. based on Real Time PCR system). Preferred Experience and Education: Experience in a wide variety of documents creation/contribution supporting qualification, validation, and release of pieces of equipment for quality control, or production (clinical and/or GMP commercial) within biopharma regulated settings. Experience in audit and inspections within regulated settings. Experience in Quality Assurance Release responsibilities within regulated settings. Experienced in Software application deployments and administration. Experience in analytical method validation. Experience in manufacturing process validation. Experience with IT infrastructure, computer/digital systems, and software solution deployments for biopharmaceutical business operations. Contributed to manufacturing site deployment activities in the biopharmaceutical ind ustry. Experience in project management for operational excellence and lean concepts in the regulated pharmaceutical industry. Competencies: Shows can-do attitude, analytical and effective problem-solving skills (e.g. root cause analysis), attention to detail, high level of accuracy, flexible reasoning, ability to prioritize, critical thinker, high performing individual under tight timelines. Shows strong verbal and written communication and excellent technical writing including proficient use of Microsoft Excel, Word, and Power Point. Work Environment: This position works in a typical office and/or lab and/or manufacturing clean room environment and/or other supporting facility areas with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Travel required: Able to work on-site: work includes traveling between different local collaborating U.S. sites and able to work in different working environments incl. office space, controlled rooms (laboratory, production facility). Physical demands: Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder. Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Pushing - Exerting force upon an object so that the object moves away from the object. Pulling - Exerting force upon an object so that the object moves toward the force. Sitting – remaining in a sitting position for at least 50% of the time. Standing/Walking - remain on one's feet in an upright position at a workstation. Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Work authorization/security clearance requirements : Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment Affirmative Action/EEO statement : Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. What do we offer? At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics Comprehensive Benefits : Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off – 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K (club together) 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverage including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth : Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.

Posted 3 weeks ago

Endpoint QA Automation-logo
Endpoint QA Automation
ForcepointCampbell, California
Who is Forcepoint? Forcepoint simplifies security for global businesses and governments. Forcepoint’s all-in-one, truly cloud-native platform makes it easy to adopt Zero Trust and prevent the theft or loss of sensitive data and intellectual property no matter where people are working. 20+ years in business. 2.7k employees. 150 countries. 11k+ customers. 300+ patents. If our mission excites you, you’re in the right place; we want you to bring your own energy to help us create a safer world. All we’re missing is you! Forcepoint is looking for a highly experienced Automation Engineer to join our QA team in the Campbell, CA office . In this role, you will work testing and automation for the endpoint . The role requires both manual QA as well as the ability to automate the test cases to reduce the manual QA efforts and achieve higher efficiency. We are not looking for a standard manual QA tester, we are looking for an engineer with a strong System and IT background, that is capable of writing scripts using python or mac Automator or other macOS endpoint automation tools . The nature of the role requires an innovative mind that will be looking for ways to overcome the protection that we develop and to think and simulate how users work in different environments with many different products and means to send or copy data outside of the organization. Specific Responsibilities/Functions Understand customer environment/ behavior and create a detailed test plan Create a detailed Test design for new product features Create a detailed Test cases and test scenarios Understand the product/module requirement s and write detailed test plans . Write automation scripts for new features in python or power shell. Review product documentation and provide feedback Work and investigate new products and new versions of products (like Dropbox, WeChat, Syncplicity) to identify all new capabilities of products that DLP should protect. Investigate and learn new Operating system features and limitations like macOS BigSur to educate about new options for data theft that the product needs to protect Working on a tight schedule to meet customer needs on time. Work from the Campbell site up to four times a week as needed. Requirements : At least 5+ years’ experience in QA Automation Perl script development experience is a must have Automated testing experience by using VMWare based virtual environments Scripting Abilities – using Python , bash or another script/shall knowledge. Background in security technologies and products Experience working with one or more of the following AD Virtualization security servers Setup an Azure Information Protection Citrix XenApp | XenDesktop VMWare Horizon Forcepoint is committed to fair and equitable compensation practices. The salary range for this role is $116,100.00 - $134,500. 00 and represents the low and high end of compensation for this position. Actual salaries are determined by various factors including, but not limited to, location, experience, and performance. The range listed is just one component of Forcepoint’s total compensation package for employees. Other rewards may include bonuses, paid time off policy, and many region-specific benefits. Don’t meet every single qualification? Studies show people are hesitant to apply if they don’t meet all requirements listed in a job posting. Forcepoint is focused on building an inclusive and diverse workplace – so if there is something slightly different about your previous experience, but it otherwise aligns and you’re excited about this role, we encourage you to apply. You could be a great candidate for this or other roles on our team. The policy of Forcepoint is to provide equal employment opportunities to all applicants and employees without regard to race, color, creed, religion, sex, sexual orientation, gender identity, marital status, citizenship status, age, national origin, ancestry, disability, veteran status, or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity. Forcepoint is committed to being an Equal Opportunity Employer and offers opportunities to all job seekers, including job seekers with disabilities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access the Company’s career webpage as a result of your disability. You may request reasonable accommodations by sending an email to recruiting@forcepoint.com . Forcepoint is a Federal Contractor. Certain positions with Forcepoint require access to controlled goods and technologies subject to the International Traffic in Arms Regulations or the Export Administration Regulations. Applicants for these positions may need to be "U.S. Persons," as defined in these regulations. Generally, a "U.S. Person" is a U.S. citizen, lawful permanent resident, or an individual who has been admitted as a refugee or granted asylum. Applicants must have the right to work in the location to which you have applied.

Posted 30+ days ago

Manager, QA Systems-logo
Manager, QA Systems
CatalentHarmans, Maryland
Job Title: Manager, Computer Systems Validation City: Harmans State : MD JOB DESCRIPTION : Serve as the QA-CSV liaison with the Engineering, Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to Apprentice Tempo Electronic Batch Records (eBR) and Manufacturing Execution System (MES) module along with other systems integrations, Lab vantage LIMS and LES modules, Electronic Laboratory Notebook (ELN), OpenText Documentum Electronic Document Management System (EDMS), MODA Software, JDE Edwards etc. Design and Software Development Life Cycle (SDLC) of the site automated systems including bioreactors, SCADA, OSISoft PI Data historian, Environmental Monitoring Systems, chromatography systems, AST Genesys Filling semi-automated machines, autoclaves and critical utilities. Review and approve equipment/software specifications including Configuration Specification (CS), User Requirement Specification (URS), Design and Functional Requirements (DS/FRS), qualification protocols including IQ/OQ/PQ and summary reports. Provide QA oversight for the site on global implementation of CSV policy and review System Impact Assessment (SIA), Data Integrity Assessments to ensure computer systems compliance with 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity. Support GMP manufacturing Computer System Validation including Pall iCELLis, Cytiva, Sartorius, Thermo Fischer bioreactors, Beckam Cell counters and Repligen Tangential Flow Filtration and Sartorius Filter Integrity Testers, Wave and AKTA (Ready/Pilot) with unicon central networking systems, Sartorious Gen II/III bioreactors for use. Review and Approve lab computer systems validation documents to induct in the quality control laboratories includes PH meters, Total Organic Carbon, Double droplet PCR, Chemidoc, qPCR systems, Osmometers, Cell counters Vicell XR and Vicell Blue, Solo VPE, Bruker MALDI-TOF with Charles River database integration, Endo safe units etc., Provide QA oversight for Data Integrity Assessment for new systems as well as existing systems and its gap remediation like security, data management and disaster recovery. Provide QA support for the Infrastructure qualifications that include Files Share, Networks, switches, VLAN and applications like MOveIT. Support and maintain the validation status of the Backup, Restore, Archive Retrieval process, experience on the NAS Synology, Netback and Unitrends applications. Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives; Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements while identifying data integrity risks and propose improvement plans Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities; Provide QA support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Perform Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA) from the Deviations investigations. Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools. Serve as the QA-CSV resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines Review and approve Standard Operating Procedures (SOPs) for the computers systems operation and administration and participate in site and corporate quality continuous process improvement initiatives; Support client and regulatory audits. EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Master’s degree in Pharmaceutical Chemistry and 3 years of experience in job offered or 3 years of experience in the Related Occupation RELATED OCCUPATION: Senior Validation Engineer or any other job title performing the following job duties: Design and Software Development Life Cycle (SDLC) of the site automated systems including bioreactors, Building Managesment, Environmental Monitoring Systems, chromatography systems, and critical utilities. Review and approve equipment/software specifications including Configuration Specification (CS), User Requirement Specification (URS), Design and Functional Requirements (DS/FRS), qualification protocols including IQ/OQ/PQ and summary reports. Author, Review and Approval of System Impact Assessment (SIA), Data Integrity Assessments to ensure computer systems compliance with 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity. Support GMP manufacturing System Validation. Author and Review Data Integrity Assessment for new systems as well as existing systems and its gap remediation like security, data management and disaster recovery. Author review and approval of the infrastructure support systems. Support validation and maintain the validation status of the Backup, Restore, Archive Retrieval backup tools used in the disaster recovery management. Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives; Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements while identifying data integrity risks and propose improvement plans. Serve as SME supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities; Provide SME support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Perform Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA) from the Deviations investigations. Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools. Lead and managed commissioning and qualification of capital projects for expansion projects of cleanroom and utilities like such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines. Review and approve Standard Operating Procedures (SOPs) for the computers systems operation and administration and participate in site and corporate quality continuous process improvement initiatives; Support client and regulatory audits. SALARY RANGE : $122,075.00.00 to $163,240.00/year JOB TIME : Full Time 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 2 weeks ago

Construction QA Supervisor (On-site) - Multiple Sites (AZ, GA, OH)-logo
Construction QA Supervisor (On-site) - Multiple Sites (AZ, GA, OH)
Decima InternationalPhoenix, Georgia
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. 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 inspection 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 of 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: Multiple Sites (On-site) Conesville, Ohio Atlanta, Georgia 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: Multiple Sites (On-site) Conesville, Ohio Atlanta, Georgia 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 3 weeks ago

E2 Optics logo
QA/QC Coordinator
E2 OpticsNew Albany, Ohio

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Job Description

Join Our Team as a QA/QC Coordinator at E2 Optics!

CLICK HERE to learn more!

E2 Optics is a rapidly growing, award-winning, woman-owned technology integrator that specializes in low voltage solutions. We're looking for a Quality Assurance/Quality Control Coordinator to ensure that all our projects are executed in compliance with industry and customer standards. If you have a passion for quality management, experience in cabling or data center installations, and a knack for problem-solving, we want you on our team!

Why Join E2 Optics?

    • Award-Winning & Woman-Owned: Be part of a company that’s transforming the technology integration industry.
    • Career Growth: Develop your skills with opportunities for coaching and training.
    • Dynamic Culture: Join a team that embraces innovation, continuous improvement, and a collaborative spirit.

What You'll Do:

    • Safety First: Comply with worksite safety standards and promote safety within the team.
    • Quality Assurance: Develop and execute the E2 Optics Quality Management System (QMS) for every project.
    • Collaboration: Partner with internal and external stakeholders to ensure adherence to quality standards.
    • Inspections & Reporting: Conduct quality inspections, generate data analytics, and track nonconformance reports.
    • Continuous Improvement: Drive Lean initiatives and contribute to the success of quality-driven projects.
    • Training & Coaching: Train internal teams on quality standards and procedures.

What We're Looking For:

    • Education:
    • High school diploma or GED required.
    • Experience:
    • 2+ years of field experience with structured cabling or data center cabling installations.
    • Experience with fiber installation and testing.
    • Skills:
    • Strong communication and coaching abilities.
    • Analytical, decision-making, and problem-solving skills.
    • Proficient in Microsoft Office (Outlook, Word, Excel).
    • Ability to work under pressure while maintaining a positive, detail-oriented approach.
    • Experience with technical writing and developing QA/QC procedures is a plus.
WHAT WE OFFER:
- Competitive pay
- Opportunities for professional development and career growth.
- BICSI Training Facilities
- A supportive and inclusive work environment.
- Health, dental, and vision insurance.
- Paid time off and holidays.

WORK ENVIRONMENT & PHYSICAL DEMANDS: The standard work environment for this position is an indoors business office and construction environment. Ability to use a computer and/or hand tools while sitting or standing for extended periods of time. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is regularly required to sit, talk or hear, use hands, stoop, kneel, bend, rotate, push, pull, reach with hands and arms on intermittent to regular basis daily. The employee is frequently required to stand and walk. The employee must regularly lift and/or move up to 50 pounds and frequently lift and/or move up to 25 pounds. The employee must regularly carry and climb ladders to 20 feet. The employee may be required to work in tight, confided spaces. The employee must demonstrate regular and on-time attendance. There could be a requirement of occasional travel by conventional means including aircraft, motor vehicle and the like within the region and to other locations as required. The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job.

DISCLAIMER: The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions. 
An Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Actively recruits qualified women, minorities, disabled and veterans for all positions for which they are qualified.

TEXTING TERMS OF SERVICE: We may send text messages you have consented to receive. Message frequency may vary. You can cancel text messages at any time by texting "STOP". After you send "STOP", we may send you an additional text message to confirm that you have been unsubscribed. You will no longer receive text messages from that phone number, or from any member of our team. If at any time you have questions about the text messages, text "HELP". After you send "HELP" we will respond with instructions on how to use our service as well as how to unsubscribe. Message and data rates may apply.

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