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Quality assurance specialist jobs in Sammamish, WA

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  • Quality Assurance Manager: 1st shift; Monday-Friday 7am-3:30pm

    Skills Inc. 4.2company rating

    Quality assurance specialist job in Auburn, WA

    Skills Inc., one of Washington State's largest aerospace suppliers offers world-class, competitively-priced products and services which exceed customer's requirements for rigorous standards and excellence. We are a fully integrated, self-funded non-profit with a social mission to train, employ and serve persons with disabilities and our community. JOB SUMMARY As part of our recent growth, we are seeking an experienced Quality Assurance Manager to join our manufacturing team. The ideal candidate will be the primary point of contact for employee driven quality related issues, customer and supplier inquiries, audits, and quality/operational improvement activities. ESSENTIAL DUTIES AND RESPONSIBILITIES • Team oriented and able to develop constructive, cooperative, long-term working relationships to support a culture of inclusion consistent with Skills social mission. • Support and lead internal/external audits to ensure and verify compliance to all applicable requirements including FAA, AS9100, Nadcap, and Customer specific requirements. • Provide comprehensive, technical advice, support, and training to manufacturing and inspection personnel. • Develop, maintain, implement, and deliver training curriculums to support quality related and inspector competencies. • Forecast staffing requirements and work with leadership and HR to have sufficient staff identified and trained to meet production needs. • Assess quality performance trends and develop quality improvement initiatives. • Work closely with the Continuous Improvement Manager to refine and enhance products and processes by applying continuous improvement and lean manufacturing principles and techniques. • Modify and develop work instructions and inspection documents to ensure compliance with product, process, and system requirements. • Lead and complete timely Root Cause Corrective Action (RCCA), 5-Why Analysis, or similar systematic approach to investigate and solve product and process nonconformities. • Comply with all federal, state, company, and customer requirements. SUPERVISORY RESPONSIBILITIES This position is responsible for direct management and supervision of department employees, including Inspection Personnel, Quality Engineers and additional SME's. Carries out these responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. PREFERRED QUALIFICATIONS • Able to communicate and provide technical assistance with internal and external customers at all levels of our organization. • Team oriented. Excellent interpersonal skills and able to be effective in a wide variety of situations with a wide variety of personalities. • In-depth knowledge of aerospace drawings, specifications, and machine tools as well as manufacturing processes. • In-depth knowledge of manufacturing practices, including CNC machining, sheet metal disciplines, forming (hot and cold), assembly, and inspection. • In-depth knowledge of quality engineering theories and principles, inspection techniques, tools, and equipment. • Solution oriented, able to define problems, collect data, establish facts, and quickly draw conclusions to solve a wide range of difficult problems in practical and cost-effective ways. • Thorough knowledge of AS9100 quality system requirements and their application. • Expert in Root Cause Corrective Action (RCCA), 5-Why Analysis, or similar systematic approach to problem solving. • Proficient with Microsoft Outlook, Word, and Excel. • Ability to write clear, accurate, comprehensive, and concise communications and documents. LANGUAGE SKILLS • Ability to read, write, communicate, and/or follow written and verbal instructions in English. Use of American Sign Language or adaptive technology is acceptable in this position. CONFIDENTIALITY The responsibilities of this position may require an individual to access and hold in confidence certain information. This means that information and/or documentation acquired about employees, suppliers, customers, business practices, and all other related information remains confidential. PREFERRED EDUCATION/EXPERIENCE • Minimum of ten (10) years aerospace manufacturing and inspection experience or related work experience. • Minimum of Five (5) years of supervisory/management experience in an aerospace manufacturing role • Continuous/Lean Improvement - Six Sigma Green Belt • ASQ Certified Quality Engineer or Quality Manager ITAR - US PERSON STATUS Due to Skills Inc.'s participation in the defense industry, International Traffic in Arms Regulations (ITAR) requires that access to sensitive information and material pertaining to defense and military related technologies may only be accessed, viewed or shared by US Persons as defined by law. A "US Person" can be a US citizen; a lawful permanent legal resident or an individual who has been admitted as a refugee or asylee. PHYSICAL DEMANDS/WORK ENVIRONMENT The physical demands and work environment described here are representative of those that must be met by the 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. • Frequent periods of standing and/or movement. • Frequent periods of sitting at a work station. • Frequent repetitive motions. • Occasional exposure to loud noises. • Occasional ability to lift up to 35 pounds. • Occasional exposure to chemical smells. Definitions: Constant (5-8 hrs. /shift) Frequent (2-5 hrs. /shift) Occasional (Up to 2 hrs. /shift) SHIFT ASSIGNMENT 1st Shift; Monday-Friday 7am-3:30pm TOTAL REWARDS SUMMARY At Skills Inc., our most important partnership is the one we share with our employees. We are dedicated to supporting the health and well-being of our employees and their dependents, which is why we offer a comprehensive and valuable benefits package that includes medical, dental, vision, life and AD&D insurance, paid time off and a 401(k) savings plan to eligible employees. SALARY DESCRIPTION Please note that the salary information shown below is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations. Skills Inc. is a self-supporting Social Enterprise and is organized as a 501 (c) (3) non-profit. We have three lines of business; Aerospace Manufacturing, Aerospace Finishing, and Business Solutions, that operate in 2 locations. Skills Inc. employs over 250 people and our social mission is to train, employ and serve persons with disabilities. We accomplish our mission three ways; direct hire, vocational programs and services, and as a resource to the community. Salary Range: $125k-$150k BENEFITS SUMMARY Paid Vacation* Paid Sick 401(k) with a percentage company-match contribution* Paid holidays*- prorated based on shift Medical, dental, vision, and life insurance* Long-term disability* Employee Assistance Plan EEO and ADA STATEMENT Skills Inc. is committed to cultivating a culture of diversity, equity, and inclusion. We invite employees, participants in our services, vendors, and customers to bring their authentic selves to every interaction. We strive to represent the communities in which we serve. We aspire to see and value people across the spectrums of age, ability, gender, race, sexual orientation, perspectives, and other visible and invisible differences. Skills Inc. embraces equitable practices at the center of our daily work and, believe our organization is stronger for it. Skills Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. OTHER DUTIES This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required. New responsibilities, activities, and duties may be modified or added at any time by a member of the management team. 1st Shift; Monday-Friday 7am-3:30pm
    $125k-150k yearly Auto-Apply 58d ago
  • Sr Manager, Quality Assurance - Cell Therapy

    Sonoma Biotherapeutics 4.3company rating

    Quality assurance specialist job in Seattle, WA

    Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information, visit sonomabio.com and follow on X, formerly Twitter, and LinkedIn. Job Purpose/Summary: This role reports to the Director of Quality Assurance and works closely with Manufacturing, Quality Control, Supply Chain, Patient Operations, and CMC project teams. This role is based in Seattle, WA, with periodic travel within North America as required. Role and Responsibilities: * Perform all activities required to complete Final Drug Product Lot disposition * Oversee the generation of all disposition certification as applicable; CoA, Dose, etc. * Proactively coordinate internal and external functions to enable Final Drug Product Lot disposition within a standard number of calendar days * Actively work with internal and external partners to mitigate risks and identify solutions to lot disposition constraints/delays * Provide oversight to quality system records related to final drug product manufacturing lots and Quality control testing (CAPAs, Change Controls, deviations, OOS/OOT events) * Manage archival of Final Drug Product lot disposition documentation * Function as a lot disposition Subject Matter Expert * Provide general support as required for additional quality assurance functions, e.g., vendor qualifications and audits, document management, etc. * Identify and implement process improvements Qualifications and Education Requirements: * Bachelor's degree and 10+ years of pharmaceutical industry experience, at least two years of which must involve direct performance of disposition activities and or manufacturing for a cell therapy final drug product * Demonstrated knowledge of the application of cGMPs applicable to biologics and cell therapy manufacturing * Ability to anticipate operational constraints/issues and proactively take or recommend solutions * Demonstrated ability to act as an individual contributor capable of defining and driving work independently, while exercising strong judgement and decision-making Competencies Needed: * Advanced knowledge and experience with cGMP manufacturing, Quality, and compliance * Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve disposition objectives * Demonstrated leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk, and delivering value-added business results that meet high-quality requirements with tight deadlines * Ability and desire to effectively communicate simple and complex issues in written format or in person through face-to-face or virtual (MS Teams) environments Working Conditions: * Up to 25% travel within North America * Work is performed in a typical office environment with standard office equipment available and used * Work is generally performed seated but may require standing and walking up to 20% of the time Other duties: Please note this job description is not designed to cover or contain a comprehensive list 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. Equal Employment Opportunity At Sonoma Biotherapeutics, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees. Sonoma Biotherapeutics is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply. Please submit your resume along with a cover letter to ********************* - resumes may also be submitted without applying for a specific job. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us at *********************
    $106k-155k yearly est. Easy Apply 57d ago
  • QA Technical Manager

    Devselect

    Quality assurance specialist job in Seattle, WA

    Title: QA Technical Manager Openings: 1 Type: Full-time Hire Reporting into the Senior Manager of Game QA, the Technical Test Manager is responsible for building a team focusing on automation within QA and quality related topics surrounding the understanding and testing of GDK's, new OS's, SDK updates, performance testing and various other technical areas of the QA org across all platforms. The Technical Test Manager will work closely with Game Leads and technical testers in the QA org as well as SDETS, developers and engineers both inside and outside of Central Tech. Tasks and Duties Work with the QA Senior Manager to build an automation test team Define and build automation test strategies both short and long term Aid in the recruitment for technical QA positions and assist in the training, mentoring and development Manage an internal technical QA team, spanning automation, core tech, performance, security, database integrity and infrastructure Work closely with QA client leadership, core tech and business stakeholders to drive automated processes on a project-by-project basis Be responsible for driving the education and importance of automation within QA and throughout the business Assess and evaluate current manual processes and tools, highlighting bottlenecks and finding alternatives to aid in bolstering efficiency Assess and evaluate new tools/software for QA and automation Aid the business and development teams with difficult/technical investigations surrounding issues uncovered through negative KPI trends and/or Customer Support escalations Track and highlight the release of both new hardware and software, gaining early hands-on insight into betas where plausible Manage any device farm needs to support test efforts Understand our sister companies' automation journeys, sharing experiences and learning from one another while assessing where crossover efforts could benefit all parties Where required, support the client test efforts to meet business deadlines Regularly monitor the health of our portfolio of apps via monitoring tools Work with QA management and other Central Tech groups to create quality KPI reports Qualifications Proven experience with automation tools and how to use these to better the QA process Previous experience building QA teams, preferably QA automation teams A strong understanding between the communication of Client and Server Exceptional leadership and managerial skills with proven experience Strong verbal/written communication & an excellent attention to detail Strong time management, accountability, and organizational skills An ability to negotiate and ensure your team's message is heard Energetic, enthusiastic, and self-motivated Flexible and able to work in a fast paced, chaotic environment with changing deadlines The ability to multitask and manage coverage for multiple high-profile projects within deadlines A strong commercial awareness, with an understanding of business priorities and goals Exceptional reporting capabilities Technical understanding and experience of back-office tools Extensive experience in test suite creation and maintenance Extensive knowledge of JIRA and/or similar bug tracking tools
    $85k-137k yearly est. 60d+ ago
  • Landscape and Stormwater Quality Assurance Manager - BTB

    Aqualis

    Quality assurance specialist job in Edmonds, WA

    About Us AQUALIS is the nationwide leader of comprehensive water management services focused on maintaining, inspecting, and repairing post-construction storm water and lift station systems. From stormwater, to wastewater, to drinking water, environmental challenges are forecasted to grow exponentially in the coming years due to aging infrastructure, climate change and the intensity of storms, urbanization and lack of compliance commitments today. AQUALIS delivers comprehensive sustainable water management to the retail, commercial, industrial, municipal, healthcare and education industries as well as HOAs and multi-family properties. AQUALIS' expertise includes storm water and lift station inspections, maintenance, repair, consultations, and emergency response, hydro-excavation, industrial vacuumation, jetting services, CCTV pipe inspections and water quality testing. We provide our clients with environmental compliance while inspiring change by preserving and protecting our community's water systems. Why work with AQUALIS? AQUALIS provides sustainable water compliance and management solutions for the betterment of our nation's communities and corporations. Working at AQUALIS is a unique opportunity to be a part of an environmentally progressive, sustainable water management team that performs at the highest professional level. We pride ourselves on respect, loyalty, integrity and inclusion. Our Company's culture is supported by our core values: Personal Responsibility & Accountability, Exceptional Customer Experience, and Sustainable & Innovative Water Management. We are committed to providing personal and professional development through continuing education, investment in tools and technology, and position-related training. AQUALIS provides all full-time employees with competitive annual pay raise potential, paid vacation time, eligibility to enroll in a company sponsored group healthcare plan, 401(k) matching, as well as real flexibility and growth potential. Specific Duties: Supervise subcontracted sites Manage schedules with subcontractor maintenance to ensure proper quality control on properties. Manage closeouts of completed work by subcontractors through the CRM system. Manage asset tracking of sites in respective regions to ensure proper info is relayed to the subcontractor. Build scopes of work on issues relayed from subcontractors or found during quality control inspection. Manage subcontractor and in-house crew tasks on customer facilities to ensure compliance with safety and all customer protocol. Oversee the performance of general environmental maintenance activities Oversee the operations and maintenance of company equipment which includes company assigned vehicle and tools / equipment Complete maintenance & inspection reports and tracking expenses as needed Oversee the maintenance and improvements of storm drainage systems and ponds Oversee the operation of landscaping equipment including weed eaters, blowers, mowers, shovels, chainsaws, etc. Oversee the disposal of sediment, trash and debris from storm water systems Travel to job sites, in a variety of weather conditions, to ensure quality control, process improvement and completion of work at sites. Regional travel ~ 4-5 days / week (All travel expenses are covered by the Company, no reimbursement needed!) Completion of additional tasks as assigned by leadership.
    $85k-137k yearly est. 45d ago
  • Lab Sciences QA Manager

    Altasciences Co

    Quality assurance specialist job in Everett, WA

    Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. About The Role The QA Manager - Lab Sciences will be responsible for managing QA staff and resources to ensure efficiency across functions and sites in support of Lab Sciences operations. They will also be responsible for staff development and align with strategic plan needs. Their goal will be to integrate internal and external quality info inputs to quickly adapt and modulate QA activities. The QA Manager - Lab Sciences will also utilize the application of risk assessment approaches within QA operations. Their goal will be to insure QA operations consistently meet internal and external timelines. They will be expected to be the second level of quality issue escalation / conflict resolution. What You'll Do Here Maintain and monitor Key Performance Index related to QA pertinence and timelines. Manage the internal inspection program and ensure its completion on an annual basis. Identify and coordinate training within the group. Approval of audit plans to ensure they're adequate and reflective of the needs identified from risk assessment strategies and various quality input information. Participate in the coordination and logistics of sponsors and/or regulatory authorities inspections. Prepare annual staff development plans, provide resources towards their completion, and perform adequate follow-ups through regular 1:1 staff meetings. Integrate quality inputs to modulate QA activities strategies and focus. Provide quarterly quality reports to the director on initiatives, risk assessment approaches, and results. Participate in the review of regulatory agency and/or sponsor's deficiency letter to ensure they're adequate, complete, compliant, and with the required courtesy and tact. Lead identified quality initiatives/projects identified through QMS, sponsor audits, and/or regulatory inspection audits. What You'll Need to Succeed Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field with a minimum of five years experience, or equivalent combination of education and experience, in the pharmaceutical industry. Extensive knowledge of GLP and clinical sample analysis experience. Knowledge and understanding of the applicable US, Canadian, European, and ICH pharmaceutical regulations and guidelines. Detail oriented and ability to meet tight deadlines. Project management and coordination skills. Tactful, reliable, persuasive, dependable, consistent, flexible. Excellent written and oral communication skills. Software: Microsoft Office. What We Offer The pay range estimated for this position is $90,000 - $115,000 annually. Please note that hourly rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. Benefits Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences' Benefits Package Includes: Health/Dental/Vision Insurance Plans 401(k)/RRSP with Employer Match Paid Vacation and Holidays Paid Sick and Bereavement Leave Employee Assistance & Telehealth Programs Telework when applicable. Altasciences' Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program #LI-ES1 MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
    $90k-115k yearly Auto-Apply 45d ago
  • Supplier Quality Systems Specialist (Quality Multi-Function)

    Jeppesen 4.8company rating

    Quality assurance specialist job in Tukwila, WA

    Company: The Boeing Company Boeing Defense, Space and Security (BDS) has an exciting opportunity for a Supplier Quality Systems Specialist (Associate or Mid-Level) to join our team supporting the P-8 program in Tukwila, WA! Level 2 Assists in review of proposals, contracts, regulatory, program and customer requirements to prepare quality assurance plans and tests for hardware and software products, processes and services. Maintains Quality directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed using established procedures. Collects and verifies data to support the identification of root cause routine problems. Provides ideas and concepts for corrective action development. Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements. Assists with hardware, software and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements. Documents audit results in standard formats. Compiles data and provides recommendations for material review disposition. Works under general supervision. Level 3 Develops quality metrics, design and production certification plans for large programs to ensure compliance with contractual, Company and regulatory requirements. Develops Quality criteria to support supplier oversight activities. Provides interpretation of complex requirements. Leads various reviews to ensure quality attributes are incorporated into supplier product designs and verification methods Analyzes non-conformance trends to evaluate effectiveness of corrective actions. Develops and implements corrective actions. Performs benchmarking and other forms of advanced analysis to ensure specified processes capability levels are achieved. Works under general direction. Basic Qualifications (Required Skills/Experience): 1+ years of experience collecting data from multiple sources, performing analysis and presenting data 1+ years of experience performing statistical analysis 1+ years of experience working with data visualization 1+ years of experience with process or value stream mapping 1+ years of experience with root cause analysis and corrective action (RCCA) methods 1+ year of experience with Quality Inspection Preferred Qualifications (Desired Skills/Experience): Bachelor's Degree or higher in a related field Experience working with the Boeing Problem Solving Model 1+ years of experience in Aerospace or manufacturing 3+ years of experience collecting data from multiple sources, performing analysis and presenting data 3+ years of experience performing statistical analysis 3+ years of experience working with data visualization 3+ years of experience with process or value stream mapping 3+ years of experience with root cause analysis and corrective action (RCCA) methods 3+ years of experience with Quality Inspection Drug Free Workplace: Boeing is a Drug Free Workplace where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies . Travel: This position requires travel up to 10% of the time Shift: This role will be on 1st shift At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities. The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work. The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements. Pay is based upon candidate experience and qualifications, as well as market and business considerations. Summary pay range: Level 2 (Associate) USD $77,350 - $104,650 Level 3 (Mid-Level) USD $94,350 - $127,650 Language Requirements: Not Applicable Education: Not Applicable Relocation: Relocation assistance is not a negotiable benefit for this position. Export Control Requirement: This position must meet export control compliance requirements. To meet export control compliance requirements, a “U.S. Person” as defined by 22 C.F.R. §120.15 is required. “U.S. Person” includes U.S. Citizen, lawful permanent resident, refugee, or asylee. Safety Sensitive: This is not a Safety Sensitive Position. Security Clearance: This position requires the ability to obtain a U.S. Security Clearance for which the U.S. Government requires U.S. Citizenship. An interim and/or final U.S. Secret Clearance Post-Start is required. Visa Sponsorship: Employer will not sponsor applicants for employment visa status. Contingent Upon Award Program This position is not contingent upon program award Shift: Shift 1 (United States of America) Stay safe from recruitment fraud! The only way to apply for a position at Boeing is via our Careers website. Learn how to protect yourself from recruitment fraud - Recruitment Fraud Warning Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. EEO is the law Boeing EEO Policy Request an Accommodation Applicant Privacy Boeing Participates in E - Verify E-Verify (English) E-Verify (Spanish) Right to Work Statement Right to Work (English) Right to Work (Spanish)
    $94.4k-127.7k yearly Auto-Apply 4d ago
  • Quality Systems Specialist

    Insight Global

    Quality assurance specialist job in Everett, WA

    An employer is looking for a Quality Systems Specialist to work in a hybrid role in the Seattle, WA area. This individual will leading quality reviews of proposals, contractors, regulatory, program and customer requirements. They will lead multi-function groups to develop company directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed. They are also in charge of stakeholder engagement in the analysis of the process data. This individual will conduct research, compile and analyze performance reports and process control statistics to continuously improve process capability. It is important they will develop & apply AS9145 / Advanced Product Quality Planning (APQP) tools, training & processes in collaboration with business unit teams to improve safety, quality & operational performance. This is a special opportunity to work on some of the most cutting edge technology is defense and space today! If this sounds like you, apply today!! We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (****************************************** Og4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (*********************************************************************************************** . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: *************************************************** . Skills and Requirements Experience with Advanced Product Quality Planning Process 5 years of experience in an engineering/manufacturing environment Experience working in a manufacturing/production environment Experience with process improvement Strong analytical and problem solving skills Experience working with internal and external suppliers Strong communication and interpersonal skills BS Engineering Experience in Statistical Process Control (SPC) Design Engineering Six Sigma certification
    $79k-103k yearly est. 60d+ ago
  • Quality Assurance Coordinator (QAC)

    Supportive Living NW

    Quality assurance specialist job in Federal Way, WA

    The Quality Assurance Coordinator (“QAC”) is responsible for ensuring the effective implementation and oversight of client support planning and service delivery in alignment with Washington Administrative Code (WACs) and Supportive Living NW (“The Company”) policies and procedures. The QAC assists in the development of client support plans-including the Person-Centered Support Plan (PCSP), Individual Instruction Support Plan (IISP), Functional Assessment (FA), and Positive Behavior Support Plan (PBSP) and provides direct guidance to support staff to promote compliance, quality, and consistency in client care. PRIMARY DUTIES AND RESPONSIBILITIES Participate in client assessments and provide feedback during the development in individualized support plans. Serve as the first point of contact for DSPs in the field, providing direction, coaching, and feedback, and escalating concerns and performance issues to the Quality Assurance Manager. Complete monthly QA Tool evaluations for each client residence to ensure WAC compliance, safe living environments, and program consistency. Review client financial records monthly, including TrueLink card reports and client ledgers, and ensure all receipts are submitted, reconciled, and properly archived. Audit client records regularly, including EMAR, progress notes, tracking logs, and goal updates, to verify accuracy, timeliness, and compliance with client plans. Oversee the overall condition and maintenance of client homes, ensuring residences remain safe, orderly, and in good repair. Coordinate with the appropriate individuals or vendors to address issues as needed. Support clients in attending medical or mental health appointments, ensuring accurate communication between providers, clients, and the care team. Participate in the on-call schedule, providing after-hours support as assigned. Perform other responsibilities as directed, based on client and program needs. REQUIRED SKILLS AND ABILITIES Strong analytical, problem-solving, and critical-thinking skills Excellent oral and written communication skills Computer data entry skills Ability to follow through and complete tasks in a timely manner Ability to redirect, coach and mentor DSPs in implementing client support plans QUALIFICATIONS, EDUCATION, AND EXPERIENCE At least 1 year of experience working with Developmentally disabled adults. Background clearance by the authorized state agency Be eighteen years of age or older Have a reliable vehicle with auto insurance and a clean driving record Qualify for Nurse Assistant Registers (NAR) or Nurse Assistant Certified (NAC)
    $58k-85k yearly est. 56d ago
  • Quality Assurance Associate - Bothell, WA

    Msccn

    Quality assurance specialist job in Bothell, WA

    ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes. What You Will Achieve In this role, you will: Execute on defined and established procedures, work instructions and templates Process documents in electronic Document Management System Answer basic questions and send routine notifications Issue and reconcile batch records, forms, and logbooks Maintain and distribute documents to Controlled Document Locations Back-up the Records Management job function as required Responsible for receiving and logging GMP records, cataloging, physical or electronic filing, and retrieval as needed Works with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in a compliant manner and are readily retrievable. Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records. Supports GMP regulatory audits and inspections ensuring timely retrieval of both physical and electronic records. Scans and digitizes GMP records and verifies as true copies. Performed reconciliation of completed records issued for GMP activities. Collects and assists with reporting on relevant metrics. Works with off-site storage facilities to ensure compliant submission and retrieval of GMP records. Contribute to milestones related to specific projects. Participates in continual improvement activities within Document Control and GMP Records management. Additional Qualifications/Responsibilities Here Is What You Need (Minimum Requirements) Bachelor's degree with any years of experience, or an Associate's degree with 3 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience Experience in the pharmaceutical industry and Quality administered systems Sound knowledge of current Good Manufacturing Practices (part of GxP) Ability to work effectively in a team environment, both within one's own team and interdepartmental teams Effective written and oral communication skills Bonus Points If You Have (Preferred Requirements) Experience at a manufacturing site. Managing and writing deviations, Change Control and CAPA Experience in production batch record issuance, reconciliation, investigation of non-conformance, root cause analysis and change control management Strong problem-solving skills Ability to work independently and as part of a team Excellent time management and multitasking abilities PHYSICAL/MENTAL REQUIREMENTS N/A NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A Work Location Assignment: On Premise The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
    $66.5k-110.9k yearly 10d ago
  • Assurance Intern - Winter 2027

    Rsm 4.4company rating

    Quality assurance specialist job in Seattle, WA

    We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, culture and talent experience and our ability to be compelling to our clients. You'll find an environment that inspires and empowers you to thrive both personally and professionally. There's no one like you and that's why there's nowhere like RSM. At RSM, interns work with large and small companies in various industries. They develop strong working relationships with clients built on understanding their businesses and challenges. Interns work on multiple team engagements each year, including several pieces of any particular assignment - not just one part. Working in a mutually respectful team environment helps our associates perform at their best and integrate their career with their personal life. Responsibilities: Understanding clients' needs and expectations, their business and industry, accounting and control systems, employees, company values and industry-related GAAP and GAAS issues Developing an understanding of the RSM audit approach and tools Assessing risks and evaluating the client's internal control structure Performing substantive tests and tests of internal controls to identify and resolve accounting or reporting issues Drafting financial statements under prescribed formats Required Qualifications: 90 credit hours completed Working towards B.A. / B.S. degree or equivalent from accredited university Accounting Major Travel to assigned client locations is required. Must have access to and ability to arrange for use of reliable modes of transportation to those locations Preferred Qualifications: A minimum 3.0 GPA Excellent written and verbal communication skills Strong computer skills, including proficiency in Microsoft Excel Ability to work effectively on a team Ability to work and multitask in a fast-paced environment At RSM, we offer a competitive benefits and compensation package for all our people. We offer flexibility in your schedule, empowering you to balance life's demands, while also maintaining your ability to serve clients. Learn more about our total rewards at ************************************************** All applicants will receive consideration for employment as RSM does not tolerate discrimination and/or harassment based on race; color; creed; sincerely held religious beliefs, practices or observances; sex (including pregnancy or disabilities related to nursing); gender; sexual orientation; HIV Status; national origin; ancestry; familial or marital status; age; physical or mental disability; citizenship; political affiliation; medical condition (including family and medical leave); domestic violence victim status; past, current or prospective service in the US uniformed service; US Military/Veteran status; pre-disposing genetic characteristics or any other characteristic protected under applicable federal, state or local law. Accommodation for applicants with disabilities is available upon request in connection with the recruitment process and/or employment/partnership. RSM is committed to providing equal opportunity and reasonable accommodation for people with disabilities. If you require a reasonable accommodation to complete an application, interview, or otherwise participate in the recruiting process, please call us at ************ or send us an email at *****************. RSM does not intend to hire entry-level candidates who require sponsorship now or in the future. This includes individuals who will one day request or require RSM to file or complete immigration-related forms or prepare letters on their behalf in order for them to obtain or continue their work authorization. RSM will consider for employment qualified applicants with arrest or conviction records in accordance with the requirements of applicable law, including but not limited to, the California Fair Chance Act, the Los Angeles Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance. For additional information regarding RSM's background check process, including information about job duties that necessitate the use of one or more types of background checks, click here. At RSM, an employee's pay at any point in their career is intended to reflect their experiences, performance, and skills for their current role. The salary range (or starting rate for interns and associates) for this role represents numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, location, etc. As such, pay for the successful candidate(s) could fall anywhere within the stated range. Compensation Range: $36 - $43 per hour
    $36-43 hourly Auto-Apply 60d+ ago
  • Clinical Documentation Specialist

    Overlake Ob Gyn, Pc

    Quality assurance specialist job in Bellevue, WA

    Welcome to a medical center where you're the center of attention. Pay range: - Hourly$44.40 - $71.93The Clinical Documentation Specialist ensures the overall quality and completeness of clinical documentation in the patient medical record through concurrent interaction with appropriate individuals. Monitors the documentation process and facilitate modifications to documentation to ensure that appropriate reimbursement and clinical severity is captured for the level of service rendered to all inpatients. Ensures that the clinical information used for measuring and reporting physician and hospital outcomes is complete. Educates all members of the patient care team on documentation policies, procedures, and regulatory agency documentation requirements.Remote Hybrid - Requires Washington State ResidencyClinical Documentation Specialist Qualifications: Graduate from an accredited school of nursing required. Bachelor's degree preferred. Three years related clinical experience in an acute care setting required. Experience interacting with physicians required. ICD-10 coding and DRG experience preferred. Requires current licensure as a Registered Nurse in the state of Washington. Must obtain Certified Clinical Documentation Specialist (CCDS) certification within twelve months of hire date. Knowledge of care delivery documentation systems and related medical records documents required. Strong communication and critical thinking skills. Ability to work independently in a time oriented environment. Certified Clinical Documentation Specialist Qualifications: Associates degree required, Bachelor's degree preferred. Three years related clinical experience in an acute care setting required. Experience interacting with physicians required. ICD-10 coding and DRG experience also required. Requires current licensure as a Registered Nurse in the state of Washington. Requires certification by ACDIS as a Clinical Documentation Specialist (CCDS). Why join Overlake? We're proud to offer benefits that support you in every stage of your career and life. But it's our inspirational culture that has made us one of America's Top 150 places to work in healthcare for several years in a row. Local, visible leaders who care about you. A values-based work environment. Medical insurance premiums as low as $0 per month. Many Overlake services covered at 100%. Tuition reimbursement up to $10,000 per year. Generous retirement plan matching starting at 5% and increasing to 7% after five years with immediate vesting. Pre-tax and Roth after tax retirement savings plans. An expanded Employee Assistance Program. A caregiver support program to help with everything from childcare to eldercare. Free parking and Orca transit passes. If this sounds like an environment where you'll thrive, we'd love to hear from you. How much will this job pay? Posted pay ranges represent the entire pay scale, from minimum to maximum. For jobs with more than one level, the posted range reflects the minimum of the lowest level and the maximum of the highest level. Some positions also offer additional pay based on shift, certification or level of education. Job offers are determined based on a candidate's years of relevant experience and internal equity. If you have questions about Overlake's pay practices, employee benefits or the pay for a specific position, please contact ***********************
    $34k-49k yearly est. Auto-Apply 42d ago
  • Quality Systems Specialist 2

    Lancesoft 4.5company rating

    Quality assurance specialist job in McChord Air Force Base, WA

    This job is with Encode, Inc a fully owned subsidiary of Lancesoft Job Description: The Company is currently seeking a Quality Systems Specialist 2 (Quality Multi-Function) to staff the Modification team in support of C-17 Modification. •Reviews and validates product nonconformance and disposition type, quality procedures and engineering requirements. •Performs analysis to identify and evaluate the quality of products, operations and processes to verify or validate compliance with Quality Management System requirements, applicable company procedures, contract requirements or government regulations. •Reviews production plans to ensure quality requirements are imbedded into the production plans. •Some positions may also be rotating shifts •Must be able to pass Ground Operations Personnel (GOP) and air respirator medical physicals and maintain qualification/certification •Ensure Modification plans complete. Required Skills: ·Able to obtain Security Clearance ·3+ years in quality assurance ·1+ years'experience having the ability to read, understand, and interpret basic engineering drawings and technical specifications ·3+ years'experience in detecting hazardous working conditions and safety problems via a regular check of equipment and work area ·3+ years'experience in repair, maintenance, and retrofit processes and practices ·1+ years of experience working from heights & using fall protection equipment with weight limitations ·Must be willing to work variable shifts, including weekends and overtime. Preferred Qualifications (Desired Skills/Experience): ·Training and/or experience in using Lean Manufacturing Principles ·Familiarity with C-17 platform ·Experience with U.S. Army or Air Force maintenance practices and experience partnering with customers to deliver services and products Typical Education/Experience: Education/experience typically acquired through advanced education (e.G. Bachelor) and typically 3 or more years'related work experience or an equivalent combination of education and experience (e.G. Master + 1 years'related work experience, 7 years'related work experience, etc.).
    $90k-115k yearly est. 20d ago
  • Quality Assurance Associate, OTF Support (temporary)

    Lumen Bioscience 3.9company rating

    Quality assurance specialist job in Seattle, WA

    . Join Lumen as a QA Associate for OTF Support in this temporary position. In this role, you'll help maintain our cGxP-compliant quality management system by supporting cGLP/cGMP/cGCP activities, conducting facility walkthroughs, and ensuring production records and documentation are complete, accurate, and audit-ready. Your work will directly support Lumen's commitment to operational excellence and regulatory compliance across our manufacturing operations. You'll perform tasks including controlled document scanning and archival, batch record and process documentation review, issuance of process documentation for scheduled manufacturing runs, and on-the-floor QA support for production teams. You'll help monitor compliance with 21 CFR part 210/211 standards through routine facility and operations walkthroughs, maintain high-quality records of activities, and collaborate closely with QA leadership to support investigations, metrics reporting, and continuous improvement of our quality systems. Duties and Responsibilities: * Perform document scanning and archival of controlled records. * Maintain accurate records of activities. * Perform on-the-floor support for manufacturing operations. * Perform issuance of process documentation for scheduled manufacturing operations. * Perform review of Batch records and related process documentation. * Conduct facility and operations walkthroughs to ensure compliance with the Company's 21 CFR part 210 /211 standard pharmaceutical cGxP quality processes. * Support the QA Manager and QA Specialist in all QA related tasks. * May assist in the preparation of metrics reports. * May assist with the investigation and triage of deviations, CAPAs, or other quality events. Qualifications & Requirements: * Educational Background: Bachelor's degree in a relevant scientific field, and/or experience in a cGXP or other regulated environment. * Technical Knowledge: Knowledge of relevant cGMP, ISO 9001, and ICH requirements as it relates to equipment and qualification. * Technical Skills: High proficiency in Microsoft Word, Excel, and SharePoint. Capable of supporting multiple projects simultaneously. * Personal Attributes: Well-organized, detail-oriented, strong technical skills, excellent written and verbal communication skills. Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment. Physical Requirements: * Ability to sit and stand for extended periods (2+ hours each). * Occasionally lift or carry items up to 20 kg. Benefits at Lumen Bioscience: * Free onsite parking or public transportation subsidies. At Lumen Bioscience, we foster a collaborative and innovative work environment where your contributions directly impact biotechnology and global health solutions. Join us and play a vital role in maintaining exceptional quality standards and regulatory compliance. Compensation Range $27 - $30 USD Create a Job Alert Interested in building your career at Lumen Bioscience? Get future opportunities sent straight to your email. Create alert
    $27-30 hourly Auto-Apply 5d ago
  • Temporary Bank Operations Quality Control Specialist

    Heritage Bank 4.4company rating

    Quality assurance specialist job in Tacoma, WA

    Our Bank Operations team is seeking a bank operations quality control specialist to fill a temporary assignment on-site in Tacoma, Washington . This position is responsible for completing deposit account quality control reviews in a timely and accurate manner, while providing quality customer service to internal/external customers. This assignment is a Full -Time on-site role, Monday through Friday 8:00 a.m. to 5:00 p.m. for approximately 180 days (December 2025 through May 2026). As a temporary employee, you will be eligible to participate in a 401(k) plan with company match, accrue sick time, and will have access to the Employee Assistance Program. Salary Range: $23.00 - $28.00 hourly The Role at a Glance: Performs quality control review for all new deposit accounts, maintenance of deposit accounts, and safe deposit boxes to ensure compliance with internal procedures and regulatory requirements. May assist with second review of bank operations high risk maintenance activities to ensure accuracy and adherence to procedure and controls. May assist with the review of department/branch general ledger reconciliations and transaction processing. May participate in the quality control review of high-risk areas including dormant account processing, negotiable instrument certifications, SOX controls and regulatory customer communications. May assist with the review of critical maintenance reports for monetary and non-monetary transactions to ensure all transactions are appropriate and supported by applicable documentation. Understands and maintains working knowledge of, and ensures bank activities are performed in compliance with, all state and federal banking laws and regulations applicable to assigned area. Understands and comply with all policies, procedures, standards and guidance relevant to assigned job responsibilities. Core Skills and Qualifications: 3+ years of recent experience in a branch and/or bank operations support role required. Working knowledge of applicable rules and regulations, report review functions and current working knowledge across various functional bank operations areas i.e., deposit operations, item processing, dormant account review, compliance strongly preferred. High School Diploma or equivalent required. Associate's degree or higher in Accounting of Finance preferred. Equivalent combination of education, experience, and training in a relevant role may be considered. Provides an exceptional level of quality service for internal and external customers and responds to customers' needs, questions and concerns in an accurate, effective, and timely manner. Effective listening verbal, written and telephone etiquette business communication skills, with the ability to read, write, speak and understand English well. Working knowledge and understanding of banking policies, procedures, and terminology related to banking laws and regulatory requirements applicable to various deposit accounts and operations. Working knowledge of deposit documentation, with the ability read/interpret documents or authorizations, ensuring accurate data input and/or approvals have been attained. Working knowledge of bank accounting practices including the understanding of debit/credit relationships; math skills to calculate interest, balance accounts and locate routine mathematical errors. Detail oriented with strong organizational and time management skills; with the ability to manage multiple assignments, ensuring that priorities are set and commitments and deadlines are met, with direct and/or moderate oversight. Excellent analytical ability, data review and processing skills, with the ability to identify and resolve exceptions and interpret data. Unquestionable integrity in handling sensitive and confidential information required. Proficient knowledge and use of MS Office products (Word, Excel, Outlook) and retrieval of data, with the ability to adapt to and learn new products and technologies quickly. Recent working knowledge of financial services systems and experience utilizing digital servicing and client file management applications, i.e., FISERV / DNA - required. Working Environment/Conditions: Climate controlled office environment. Work involves being able to concentrate on the matter at hand, under sometimes distracting work conditions and frequent employee and/or customer contacts and interruptions during the day. Work requires regular attendance, punctuality and adherence to agreed-upon schedule with willingness to work a flexible and/or rotating schedule and or extended hours, and assist at other locations or remotely, as needed. Physical Demands/Effort: Work may involve the constant use of computer screens, reading of reports, and sitting throughout the day. Ability to operate a computer keyboard, multi-line telephone, photocopier, scanner and facsimile which often requires dexterity of hands and fingers with repetitive wrist and hand motion. Typically sitting at a desk or table; intermittently standing, stooping, bending at the waist, kneeling or crouching to file materials. Occasional lifting and/or moving up to 10 lbs. (files, boxes, etc.). The above statements are intended to describe the general nature and level of work being performed and are not an exclusive list of all qualifications for this position. Heritage Bank is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability, or any other basis protected by applicable law. Job applicants have certain legal rights. Please click here for information regarding these rights. If you need assistance completing the online application, please email: ******************************* Salary Range Disclaimer The base salary range represents Heritage Bank's current salary range for the position / assignment. Actual salaries will vary depending on factors including, but not limited to, qualifications, experience, and job performance. ##JobCategory:Bank Operations## ##Street:3615 Pacific Ave## ##City:Tacoma## ##State:WA## ##ZipCode:98418## ##Internal:false## *mon
    $23-28 hourly Auto-Apply 23d ago
  • Document Specialist

    Cyfle

    Quality assurance specialist job in Auburn, WA

    We have partnered with a manufacturing company in the Auburn, WA area to provide them with a Document Specialist. Please review the below description and let us know if you are interested. Prioritized Must Have Skills for the Document Specialist: #1. Application of AS9100 in a manufacturing environment #2. 1-2 years of quality assurance experience in documents experience in aerospace manufacturing. Responsibilities of the Document Specialist: Responsible for performing Quality Document review and approval Performs the following: REVIEW SUPPLIER PURCHASE ORDERS REVIEW - all customer orders to include All production document packages Purchase Orders Customer Quality Requirements Customer Terms and Conditions Assist in answering quality questions from other administration departments, such as Order Entry, Planning, Compliance. Pull missing paperwork and correct pack slips for customers after shipment Assist in reviewing shipping documents and packing for Quality review at Shipment. Preforms other duties as assigned. Responsible for conforming to the company's quality system procedures as documented. Requirements for the Document Specialist: High School Diploma or GED preferred. Application of AS9100 in a manufacturing environment strongly preferred. 1-2 years of quality assurance experience in documents preferred experience in aerospace manufacturing preferred. Analytical and creative skills to find solutions to problems. Proficient using PC and software applications. Advanced mathematical skills. Attention to detail. Sense of Urgency. Ability to work on numerous projects at once. Strong interpersonal and personnel management skills. Other Key Requirements: 100% onsite, in-office role. NO REMOTE candidates. No sponsorships or visa holders. No Corp-to-Corp. Benefits of the Document Specialist: Medical Insurance Dental Insurance Vision Insurance Life Insurance 401(k) Program About the Company: Cyfle is a global business dedicated to connecting talents worldwide. Our comprehensive RPO services, placement services, and training services help businesses unlock their full potential.
    $34k-49k yearly est. 60d+ ago
  • Sr Manager, Quality Assurance - Cell Therapy

    Sonoma Biotherapeutics 4.3company rating

    Quality assurance specialist job in Seattle, WA

    Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Tregbiology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Tregcell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information, visitsonomabio.comand follow onX,formerly Twitter, and LinkedIn. Job Purpose/Summary: This role reports to the Director of Quality Assurance and works closely with Manufacturing, Quality Control, Supply Chain, Patient Operations, and CMC project teams. This role is based in Seattle, WA, with periodic travel within North America as required. Role and Responsibilities: Perform all activities required to complete Final Drug Product Lot disposition Oversee the generation of all disposition certification as applicable; CoA, Dose, etc. Proactively coordinate internal and external functions to enable Final Drug Product Lot disposition within a standard number of calendar days Actively work with internal and external partners to mitigate risks and identify solutions to lot disposition constraints/delays Provide oversight to quality system records related to final drug product manufacturing lots and Quality control testing (CAPAs, Change Controls, deviations, OOS/OOT events) Manage archival of Final Drug Product lot disposition documentation Function as a lot disposition Subject Matter Expert Provide general support as required for additional quality assurance functions, e.g., vendor qualifications and audits, document management, etc. Identify and implement process improvements Qualifications and Education Requirements: Bachelors degree and 10+ years of pharmaceutical industry experience, at least two years of which must involve direct performance of disposition activities and or manufacturing for a cell therapy final drug product Demonstrated knowledge of the application of cGMPs applicable to biologics and cell therapy manufacturing Ability to anticipate operational constraints/issues and proactively take or recommend solutions Demonstrated ability to act as an individual contributor capable of defining and driving work independently, while exercising strong judgement and decision-making Competencies Needed: Advanced knowledge and experience with cGMP manufacturing, Quality, and compliance Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve disposition objectives Demonstrated leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk, and delivering value-added business results that meet high-quality requirements with tight deadlines Ability and desire to effectively communicate simple and complex issues in written format or in person through face-to-face or virtual (MS Teams) environments Working Conditions: Up to 25% travel within North America Work is performed in a typical office environment with standard office equipment available and used Work is generally performed seated but may require standing and walking up to 20% of the time Other duties: Please note this job description is not designed to cover or contain a comprehensive list 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. Equal Employment Opportunity At Sonoma Biotherapeutics, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees. Sonoma Biotherapeutics is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. Weve learned from experience that some of the best people dont always match our requirements perfectly - if youre interested and think you could fit, please dont hesitate to apply. Please submit your resume along with a cover letter to ********************* - resumes may also be submitted without applying for a specific job. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us at *********************
    $106k-155k yearly est. Easy Apply 31d ago
  • Quality Systems Specialist (Associate or Mid-Level)

    Jeppesen 4.8company rating

    Quality assurance specialist job in Everett, WA

    Company: The Boeing Company Boeing Defense, Space & Security (BDS) has an exciting opportunity for an Quality Systems Specialist (Associate or Mid-Level) to join our team located in Everett, WA! We are seeking a dedicated and detail-oriented KC-46 Quality Systems Specialist to join our team. In this role, you will be instrumental in ensuring the highest quality standards are met throughout the program development lifecycle. You will review proposals, contracts, and regulatory requirements to facilitate early quality involvement, while preparing and maintaining Quality directives, policies, and procedures. Your analytical skills will be essential as you assess process data and metrics to identify root causes of issues and collaborate with stakeholders to implement effective preventive and corrective actions. If you are passionate about quality assurance and continuous improvement, and possess a strong background in quality management systems, we invite you to apply and contribute to the success of the KC-46 program. Position Responsibilities: Level 2 Assists in review of proposals, contracts, regulatory, program and customer requirements to prepare quality assurance plans and tests for hardware and software products, processes and services. Maintains Quality directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed using established procedures. Collects and verifies data to support the identification of root cause routine problems. Provides ideas and concepts for corrective action development. Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements. Assists with hardware, software and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements. Documents audit results in standard formats. Compiles data and provides recommendations for material review disposition. Works under general supervision. Level 3 Reviews proposals, contracts, regulatory, program and customer requirements ensuring early quality involvement in program development. Prepares and maintains Quality directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed. Analyzes process data, metrics, models and flows to identify root cause of problems. Participates with stakeholders to develop potential preventive or corrective actions and implementation. Conducts research, compiles and analyzes performance reports and process control statistics, to continuously improve process capability. Conducts quality source selection and process reviews of suppliers' ability to meet program quality requirements and support business decisions, and develops a coordinated response for management review and approval. Conducts hardware, software and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements and reports results to management. Analyzes data to provide material review dispositions for nonconforming materials, parts and equipment. Works under general direction. This position is expected to be 100% onsite. The selected candidate will be required to work onsite at the listed location. This position requires the ability to obtain a U.S. Security Clearance for which the U.S. Government requires U.S. Citizenship. An interim and/or final U.S. Secret Clearance Post-Start is required. Basic Qualifications (Required Skills/Experience): 1+ years of experience working across multiple business units and interfacing with key stakeholders. 1+ years of experience with QMS (Quality Management System). 1+ years of experience using all the following Microsoft Office Applications (Word, Excel and PowerPoint) 1+ years of experience with data analysis and/or data mining Preferred Qualifications (Desired Skills/Experience): Bachelor's degree or higher in related discipline 3+ years of experience with QMS (Quality Management System). 3+ years of experience using all the following Microsoft Office Applications (Word, Excel and PowerPoint) 3+ years of experience with data analysis and/or data mining Travel: This position may require up to 10% travel Shift: This position is for 1st shift At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities. The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work. The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements. Please note that the pay information shown below is a general guideline only. Pay is based upon candidate experience and qualifications, as well as market and business considerations. Summary pay range: USD Level 2 (Associate) $72,250 - $97,750 Level 3 (Mid-Level) $86,700 - $117, 300 Language Requirements: Not Applicable Education: Not Applicable Relocation: Relocation assistance is not a negotiable benefit for this position. Export Control Requirement: This position must meet export control compliance requirements. To meet export control compliance requirements, a “U.S. Person” as defined by 22 C.F.R. §120.15 is required. “U.S. Person” includes U.S. Citizen, lawful permanent resident, refugee, or asylee. Safety Sensitive: This is not a Safety Sensitive Position. Security Clearance: This position requires the ability to obtain a U.S. Security Clearance for which the U.S. Government requires U.S. Citizenship. An interim and/or final U.S. Secret Clearance Post-Start is required. Visa Sponsorship: Employer will not sponsor applicants for employment visa status. Contingent Upon Award Program This position is not contingent upon program award Shift: Shift 1 (United States of America) Stay safe from recruitment fraud! The only way to apply for a position at Boeing is via our Careers website. Learn how to protect yourself from recruitment fraud - Recruitment Fraud Warning Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. EEO is the law Boeing EEO Policy Request an Accommodation Applicant Privacy Boeing Participates in E - Verify E-Verify (English) E-Verify (Spanish) Right to Work Statement Right to Work (English) Right to Work (Spanish)
    $86.7k-117.3k yearly Auto-Apply 7d ago
  • Quality Systems Specialist

    Insight Global

    Quality assurance specialist job in McChord Air Force Base, WA

    Insight Global is looking for a Quality Systems Specialist. This position offers a full-time, onsite role at Joint Base Lewis-McChord supporting an upgrade project upgrade project. The contract duration is two years, and the work involves upgrading Aero-I/H antennas for FAA ATC Datalink compliance, modernizing legacy HF radio encryption, and upgrading ARC-210 Gen III radios to ARC-210 Gen VI. The schedule runs Monday through Friday with two shift options: first shift starting at 6:00 AM and second shift starting at 2:30 PM, each lasting 8.5 hours. Candidates must be willing to work variable shifts, weekends, and overtime as needed. Preferred experience includes C-17 aircraft familiarity and a background in the Armed Forces or aerospace modification. Physical requirements include working outdoors and on top of aircraft. Export compliance requires U.S. Person status. The team size is approximately 20 per site. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements 3+ years in Quality Assurance (airframe focus). 3+ years in repair, maintenance, and retrofit processes on military aircraft. 1+ years working from heights and using fall protection equipment (with weight limitations). Ability to read, understand, and interpret basic engineering drawings and technical specifications. Experience identifying hazardous conditions and safety issues. Must be able to obtain Secret clearance.
    $78k-103k yearly est. 19d ago
  • Quality Assurance Associate, Qualification Support (temporary)

    Lumen Bioscience 3.9company rating

    Quality assurance specialist job in Seattle, WA

    . Join Lumen as a QA Associate for Qualification Support in this temporary position. In this role, you'll support our Quality Assurance team in commissioning, qualification, and validation (CQV) activities that ensure compliance with pharmaceutical cGxP quality system processes. You'll contribute to equipment qualification workflows, maintenance management, and documentation that enable Lumen's commitment to quality excellence. You'll perform tasks including document management, record review, preventative maintenance coordination, and SOP authoring. You'll work within 21 CFR part 210/211 standards, manage qualification documentation in our electronic quality management system (eQMS), and collaborate across manufacturing and quality control teams to maintain equipment readiness and regulatory compliance. Duties and Responsibilities: * Support QA Associate and QA Specialist in commissioning, qualification, and validation (CQV) related tasks. * Perform scanning and archival of CQV documents and records. * Review maintenance and calibration related records for accuracy and completeness. * Work with manufacturing and quality control to ensure timely completion of preventative maintenance and calibration activities. * Assist with writing or reviewing qualification and validation standard operating procedures (SOPs). * Assist with writing or reviewing operation and maintenance procedures. * Determining equipment qualification gaps for manufacturing and quality control. * May assist in the preparation of CQV metrics reports. * May assist with the investigation and triage of CQV related deviations, CAPAs, or other quality events. Qualifications & Requirements: * Educational Background: Bachelor's degree in a relevant scientific field, and/or experience in a cGXP or other regulated environment. * Technical Knowledge: Knowledge of relevant cGMP, ISO 9001, and ICH requirements as it relates to equipment and qualification. * Technical Skills: High proficiency in Microsoft Word, Excel, and SharePoint. * Personal Attributes: Well-organized, detail-oriented, strong technical skills, excellent written and verbal communication skills. Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment. Physical Requirements: * Ability to sit and stand for extended periods (2+ hours each). * Occasionally lift or carry items up to 20 kg. Benefits at Lumen Bioscience: * Free onsite parking or public transportation subsidies. At Lumen Bioscience, we foster a collaborative and innovative work environment where your contributions directly impact biotechnology and global health solutions. Join us and play a vital role in maintaining exceptional quality standards and regulatory compliance. Compensation Range $27 - $30 USD Create a Job Alert Interested in building your career at Lumen Bioscience? Get future opportunities sent straight to your email. Create alert
    $27-30 hourly Auto-Apply 5d ago
  • QA Associate, OTF Support

    Lumen Bioscience 3.9company rating

    Quality assurance specialist job in Seattle, WA

    Quality Assurance Associate at Lumen Bioscience - . Join Lumen as a QA Associate for OTF Support in this temporary position. In this role, you'll help maintain our cGxP-compliant quality management system by supporting cGLP/cGMP/cGCP activities, conducting facility walkthroughs, and ensuring production records and documentation are complete, accurate, and audit-ready. Your work will directly support Lumen's commitment to operational excellence and regulatory compliance across our manufacturing operations. You'll perform tasks including controlled document scanning and archival, batch record and process documentation review, issuance of process documentation for scheduled manufacturing runs, and on-the-floor QA support for production teams. You'll help monitor compliance with 21 CFR part 210/211 standards through routine facility and operations walkthroughs, maintain high-quality records of activities, and collaborate closely with QA leadership to support investigations, metrics reporting, and continuous improvement of our quality systems. Duties and Responsibilities: Perform document scanning and archival of controlled records. Maintain accurate records of activities. Perform on-the-floor support for manufacturing operations. Perform issuance of process documentation for scheduled manufacturing operations. Perform review of Batch records and related process documentation. Conduct facility and operations walkthroughs to ensure compliance with the Company's 21 CFR part 210 /211 standard pharmaceutical cGxP quality processes. Support the QA Manager and QA Specialist in all QA related tasks. May assist in the preparation of metrics reports. May assist with the investigation and triage of deviations, CAPAs, or other quality events. Qualifications & Requirements: Educational Background: Bachelor's degree in a relevant scientific field, and/or experience in a cGXP or other regulated environment. Technical Knowledge: Knowledge of relevant cGMP, ISO 9001, and ICH requirements as it relates to equipment and qualification. Technical Skills: High proficiency in Microsoft Word, Excel, and SharePoint. Capable of supporting multiple projects simultaneously. Personal Attributes: Well-organized, detail-oriented, strong technical skills, excellent written and verbal communication skills. Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment. Physical Requirements: Ability to sit and stand for extended periods (2+ hours each). Occasionally lift or carry items up to 20 kg. Benefits at Lumen Bioscience: Free onsite parking or public transportation subsidies. At Lumen Bioscience, we foster a collaborative and innovative work environment where your contributions directly impact biotechnology and global health solutions. Join us and play a vital role in maintaining exceptional quality standards and regulatory compliance. Compensation Range $27 - $30 USD
    $27-30 hourly Auto-Apply 28d ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in Sammamish, WA?

The average quality assurance specialist in Sammamish, WA earns between $45,000 and $104,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in Sammamish, WA

$68,000
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