Quality assurance specialist jobs in Marysville, WA - 190 jobs

Hermanson Company is a standout Mechanical company that has been doing business in the Puget Sound area since 1979. Over the last four decades we have grown from a family owned sheet metal contractor to a partner led full service mechanical construction, design and maintenance provider playing a significant role in the U.S. national construction industry. By design, Hermanson is a special place to work. Our belief is that people do business with people they like. In keeping with that belief, we strive to hire and retain highly motivated people who are professional, ethically unwavering, and unrelenting in delivering quality results. We are focused on providing a workplace where high performance individuals come together to build dedicated teams driven to accomplish great things for our customers. People love working at Hermanson, because we all share the same Core Values: Clients First - Caring, win-win, value, quality and service attitude Family Matters - Safety, wellness, stability, enjoyment and balance Character Matters - Integrity, accountability, passionate, and caring Team - Trust, honesty, respect, reliable and inclusive Appreciate - Each other, our successes, and enjoy the journey Learn, Grow, Innovate - Challenge the status quo and always compete The Role Periodic travel to fabrication shops and active projects (regional and national as needed) This is not a remote role Reports To COO (or equivalent senior operations executive) Role Summary The Corporate QA/QC Manager is the single corporate authority for quality assurance and quality control across Hermanson's fabrication and field installation activities. The role owns and governs QA/QC systems supporting piping fabrication, structural steel, skids, sheet metal, plumbing, and general mechanical installation, with an initial and primary emphasis on piping and fabrication shop operations. Periodic travel to fabrication shops and active projects (regional and national as needed) This role establishes durable, auditable quality systems that project teams inherit and execute. It is a corporate leadership position, not a project inspection role. Primary Responsibilities 1. Corporate QA/QC Ownership Serve as the company-wide authority for QA/QC, welding, and fabrication quality Establish and enforce a unified QA/QC framework across all mechanical trades Maintain sole interpretation authority for applicable codes, standards, and company requirements Exercise stop-work authority for quality or compliance issues 2. Fabrication & Piping Focus (Initial Priority) Own and lead QA/QC system implementation and certification compliance for fabrication shops, with an initial emphasis on piping, skids, and structural steel. Ensure shop practices, welding, inspection, and documentation align with approved procedures Establish traceability, inspection points, nonconformance, and corrective action processes Prepare fabrication operations for audits and owner/EPC review Stabilize and integrate AWS, AISC, and ASME programs into one coherent system 3. Certification & Code Compliance Leadership Own and maintain quality programs supporting: AWS welding requirements AISC (STD) structural steel certification ASME (B31.1 power piping with Section IX welding only) Lead certification applications, audits, surveillance, and corrective actions Act as primary interface with auditors, Authorized Inspectors (AI), owners, and EPCs Ensure certification scope remains disciplined and free of unnecessary expansion 4. Welding Program Management Own the corporate welding program including: WPS, PQR, welder qualifications, and continuity Alignment between AWS and ASME Section IX requirements Ensure welding practices in the shop and field conform to approved procedures Determine appropriate use of third-party CWIs, NDT, and specialty inspection services 5. Multi-Trade QA/QC Standards (Phased Expansion) Establish corporate QA/QC standards for: Sheet metal fabrication and installation Plumbing systems General mechanical installation work Define inspection points, documentation expectations, and acceptance criteria by trade Phase implementation to avoid overloading projects while improving consistency Audit projects periodically for compliance with corporate standards 6. Training, Audits & Continuous Improvement Train shop personnel, project managers, superintendents, and foremen on quality requirements Implement nonconformance reporting, corrective action, and root cause processes Conduct internal audits and readiness reviews prior to external audits Drive continuous improvement across fabrication and field installation 7. Cross-Functional & Strategic Support Support estimating, procurement, and operations with code-compliant execution strategies Participate in risk reviews where quality, fabrication approach, or certification impacts scope Advise executive leadership on quality risk, capability gaps, and future certification needs Qualifications (Required) 10+ years experience in fabrication, welding, piping, or mechanical construction quality Demonstrated experience leading QA/QC programs at a corporate or multi-project level Proven ownership of audits and corrective actions (AISC and/or ASME preferred) Strong working knowledge of piping, structural steel, and mechanical installation practices Ability to operate effectively with executives, shop leadership, and field teams Certifications AWS Certified Welding Inspector (CWI): Preferred If not held, must be able and willing to obtain within 12 months (company supported) Experience with ASME or AISC audits is strongly preferred This role exists to own, enforce, and sustain quality standards across the enterprise, ensuring durable compliance beyond initial certifications. Compensation (Seattle Market) Base salary: $150,000 - $180,000 Full benefits package Success Looks Like Fabrication shops operate under controlled, auditable QA/QC systems AISC certification achieved and maintained without disruption ASME power piping program operating cleanly and defensibly Consistent QA/QC standards across piping, sheet metal, plumbing, and installation Project teams inherit quality systems rather than reinventing them Quality is recognized as a competitive advantage, not overhead Hermanson provides great employee benefits: Very Competitive Compensation w/Bonus Medical, dental, vision for employees (coverage available for dependents) 401k retirement plan including 3.75% Company Matching Vacation and Sick Leave Compensation (PTO), and Holiday Pay! Disability income protection Employee and dependent life insurance Growth & development opportunities In-House company training program Certificate & Tuition Reimbursement Wellness Program Employee Assistance Program Hermanson company LLC is proud to be an Equal Opportunity Employer. Hermanson does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need. Benefits found in job post 401(k), Medical insurance, Vision insurance, Dental insurance, Tuition assistance, Disability insurance

A leading aerospace company is seeking an experienced Project Manager to lead team efforts in delivering new engine test stand infrastructure. This role involves managing a skilled team focused on design, construction, and commissioning of various systems. Ideal candidates will have a Bachelor's degree in engineering, over 10 years of experience in project management, and strong leadership abilities. The position is based in Seattle, WA, and requires up to 50% travel. Competitive compensation and relocation assistance provided. #J-18808-Ljbffr

Need to sit onsite in Everett, WA (relocation assistance available) 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. Duties: 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. Qualifications: 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.

At MediScan AI, we're building an AI-native workspace designed for physicians and legal teams to analyze and report on complex, disorganized patient histories. Our tools empower users to process vast amounts of medical data efficiently, enabling faster, more accurate decision-making. As a team, we focus on blending cutting-edge AI technologies with intuitive, user-focused design to tackle one of the most underserved pain points in the med-legal industry. By joining MediScan AI, you'll have the chance to work on meaningful challenges-building scalable solutions for messy, real-world problems-and make an immediate impact at a fast-growing startup. We're not just solving technical problems; we're transforming how work gets done in med-legal, helping professionals unlock productivity and focus on what matters most. What You'll Do Own and manage the quality of each release: Take full ownership of quality assurance processes to ensure every release meets our high standards. User interface and feature testing: Conduct thorough testing of UI elements and new features to identify bugs, usability issues, and opportunities for improvement. Collaborate closely with design and leadership: Work hand-in-hand with the design team and CEO throughout the feature design and rollout process to ensure quality is embedded from the start. Develop and maintain test scripts and plans: Build comprehensive test documentation, scripts, and plans to ensure consistent and repeatable testing processes. Manage project management tickets: Review our ticketing system and collaborate with engineers to verify that tickets are complete, accurate, and meet acceptance criteria. Ensure AI-generated record review quality: Long-term, take ownership of the quality and accuracy of AI-produced medical record reviews, learning the nuances to distinguish between good and bad outputs. Qualifications Must-Haves: 2+ years of experience as a QA Engineer working on production software. Strong UX/UI intuition with a proven ability to identify usability issues and translate them into clear, actionable tickets. User experience is core to our product quality. Experience testing modern web applications, including thorough UI, feature, and regression testing. Comfort collaborating closely with engineers, designers, and product stakeholders to ensure quality is embedded throughout the development lifecycle. Experience working within a software development team, understanding release cycles, acceptance criteria, and agile workflows. Familiarity with project management and ticketing tools such as Jira, Linear, or similar systems. Excellent communication and documentation skills, with the ability to clearly describe bugs, edge cases, and quality risks. Strong ownership mindset-you care deeply about product quality and take responsibility for releases end-to-end. Nice-to-Haves: Some coding experience used to support test automation (especially front-end testing). Experience with TypeScript and frontend testing frameworks (e.g., Playwright, Cypress, Jest). Experience managing or maintaining automated test suites, including improving coverage and reliability over time. Past experience in a quality leadership or mentorship role, such as setting QA standards, reviewing test plans, or guiding other QA contributors. Background working in fast-growing startups or environments where processes are built and refined from scratch. Interest in helping scale a quality organization, with aspirations toward future leadership as the team grows. Exposure to healthcare, legal, or regulated domains (not required, but a plus). What We Offer An opportunity to make a direct impact in a fast-growing startup. Competitive salary, equity, and benefits. Equity. Hybrid Work Model with Flexible Hours.

Description: The food safety and quality technician is responsible for monitoring the manufacturing and packaging of food products to ensure Good Manufacturing Practices are adhered to and that finished products meet all specifications. It is the responsibility of all Schwartz Brothers Bakery team members to report any potential food safety and/or quality issues to their supervisor immediately Monitors production of food, including ingredient, lot code, and process verifications Measures product parameters such as weight, packaging, sensory data, and identity preservation (Organic, Non-GMO, Kosher, allergen, etc.) to ensure specifications are being met Initiates and releases product/ equipment holds for non-conformances or pending micro analysis Records product data in the Product Grading Spreadsheet. Notifies Bakery FSQ team when product is out of specification Inspects all areas of the plant daily for equipment, storage, sanitation, maintenance, and GMP issues. Resolves issues in a timely manner Monitors HACCP pre-requisite program compliance to ensure all processing practices comply with regulatory requirements and program specifications Enforces current Good Manufacturing Practices and alerts FSQ Supervisor to ongoing GMP issues. Verifies daily HACCP records, daily supervisor checks, pre-ops, oven time and temperature logs, Allergen Cleaning Forms, and sanitizer dilution monitoring Performs daily (REB) or weekly (SBB) calibration verification for scales and thermometers. Record data on the Scale Weight Calibration Record and the Ice Bath Thermometer Verification Checksheet Performs monthly validation of metal detection Monitors pest control traps on weeks with no scheduled PCO inspection. Records pest sightings in PCO Pest Sighting Log Submits work orders for FSQ related maintenance issues Provides a daily FSQ summary to FSQ Supervisor and FSQ Manager via end of day emailed report Start time: 3:00-4:00 pm End time: 1:00 am- 2:00 am Requirements: Knowledge of Good Manufacturing Practices (GMP) Previous experience in food safety or quality control preferred. Will train the right candidate HACCP certification is a plus, but not required Must obtain Washington State Food Handler's Card within 15 days of start. Intermediate to advanced computer skills with Microsoft Word, Excel, power point and Outlook Flexible work schedule - ability to work nights and weekends when needed. Multilingual is preferred BENEFITS: Discounted meals at Daniel's Broiler Paid Time Off begins at 1 hour for every 30 hours worked for new hires 401(k) with company match Health, dental, vision insurance Voluntary benefits such as LTD, commuting benefits Flexible scheduling Length of service bonuses Team member referral program Opportunity for growth and development- we promote from within! Free Employee Assistance Program with access to personal and financial resources, emotional support, and legal guidance Opportunities to give back through organized volunteer events with Food Lifeline Wage Range: $22.00 - $25.00/ hour, DOE Compensation details: 22-25 Hourly Wage PI56fc88fab5-

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 *********************

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!

The Environmental Health and Safety Coordinator is an integral part of the EHS team and helps maintain and upkeep the Safety and Environmental Management System providing EHS support for the organization and EHS team. They are the boots on the ground assigned to a project or vessel to provide shipyard competent person compliance and safety checks and inspections to work with production to keep operations safe and compliant. Focus: Daily inspection documentation and site safety. Key Responsibilities: SEMS * Implement the key elements of the Safety and Environmental Management System (SEMS) throughout the operations at the company site. EHS Leadership * Work with all levels of organizational management to report on and track compliance with safety policies, standards, plans, and procedures. EHS Policy, Standard, Program, Plans * Ensure EHS Policy, Standards, Programs, and Plans for the organization and being followed by all employees at the site level. EHS Organization Structure Responsibilities * Assist with the EHS team and needs to maintain SEMS in their operations EHS Organization Structure Responsibilities (Emergency Response, SCP teams) * Member of the location Emergency Response Team responding to all emergencies at site. Participate in ERT meetings with drills and response to ensure ERTs readiness to respond to all emergencies. Ensure exit and access routes, are well lit and labeled for all team to use. * Site Shipyard Competent Person (SCP) to check and gas free vessels at site before employees start shift work, post findings and all safety signs and notifications are clearly marked for SCP work and other hazards throughout the location. EHS Organization Structure (Training) * Ensure production teams and employees are current in their EHS training requirements to perform the work they are doing. Assist in training as needed. EHS Loss Reporting and Investigation * Work with Production and Operations to make sure all losses are reported. Assist Supervisor with collecting facts and information associated with losses ensuring completion of associated documentation. * Ensure hazards and near hits are reported by Production and Operations and followed up to ensure they are addressed. * Assist EHS team as needed for help with keeping and maintaining Manage the filing system of injuries and reports hard and soft copies. EHS Regulatory Compliance * Work with team to make sure of compliance with environmental regulations for stormwater, waste, and air permits. * Check OSHA and LNI compliance is happening at facility. Address findings where improvement is needed. EHS Audits and Inspections * Oversee the safety inspection of safety items for safety equipment, and emergency equipment as needed throughout the facility. * Perform daily inspections on assigned vessels, yard, drydocks, and facilities, document safety findings and work with operations to address safety findings. EHS Continuous Improvement * Assign action items to the team as they are found and follow up that they are completed. EHS Performance Metrics, Evaluation and Management Review * Review safety performance at organization identifying areas for improvement and working with management team to improve facility and safety concerns.

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. The primary work environment consists of a pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate. What Quality Assurance contributes to Cardinal Health: Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. Demonstrates knowledge of quality systems and approaches. Demonstrates an understanding of the relevant regulations, standards and operating procedures. Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving. Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Hours can start at midnight or 1am M-F l(3rd shift) located in Denver, CO What is expected of you and others at this level: Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks Works on projects of moderate scope and complexity Identifies possible solutions to a variety of technical problems and takes actions to resolve Applies judgment within defined parameters Receives general guidance; may receive more detailed instruction on new projects Work reviewed for sound reasoning and accuracy Accountabilities in this role: Quality Assurance responsibilities include but are not limited to CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls. Establish and report metrics related products and processes as deemed necessary by the RQM. Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP) Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities Engage and collaboration with operations department to drive quality system and CGMP requirements Responsible for product release activities per CGMP requirements Responsible for reporting quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification. Qualifications: Must be able to work NIGHTS Bachelor's of Science in Chemistry or Biology degree preferred Effective written and verbal English communication skills required 1-2 years experience in QA and/or regulated environment highly preferred - cGMP Pharmaceutical or medical device experience a plus ISO experience a plus Quality Assurance background preferred Lifting: Frequent lifting between 50-75 lbs Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions ; Ability to exercise sound judgment Personal Protective Equipment Anticipated salary range: $76,700-$98,550 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with my FlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to close: 3/28/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here

Job Title: QA Associate Reports To: Senior Manager, QA About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged, it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: We're looking for a passionate and curious QA Associate to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing. This role works collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below. What You'll Do: * Review executed Manufacturing Batch Records. * Participate in compliance walkthrough of the Manufacturing floor and other assigned areas. * Partner with Manufacturing to ensure compliance in Manufacturing operations. * Review and approve Master Batch Records and other supporting documents. * Execute process performance and product quality monitoring programs. * Alert senior management of potential deviations or compliance risks. * Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements. * Provide input on communication as to the status of deliverables to customers, management, and stakeholders. * Assist with developing training regarding QMS process or system changes. * Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records). * Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement. * Lifecycle management of the stability program for clinical and commercial products * Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones. * Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements. * Ensure that stability studies are executed according to protocol. * Review, verification, disposition, and archival of stability study data for assigned programs. * Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution. * Interpretate stability results to support expiry, trending, and conditions of products. * Support product stability related content in regulatory submission, including responses to questions and post-marketing. Who You Are: * Bachelor's Degree biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate's degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience. * Strong attention to detail * Ability to collaborate and communicate cross-functionally Why Join Us: * Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow. * Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life (hybrid model). * Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged. * Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. * A Place for Big Ideas: We don't just talk about thinking outside the box, we throw the box away. If you've got ideas, we want to hear them. Are You Still Curious? If you've read this far, then chances are you've got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you, and how it will shape the future of Just-Evotec. Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec! The base pay range for this position at commencement of employment is expected to be $65,000 to $90,000; Base salary offered may vary depending on the individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

Job Title: QA Associate Reports To: Senior Manager, QA About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged, it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: We're looking for a passionate and curious QA Associate to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing. This role works collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below. What You'll Do: Review executed Manufacturing Batch Records. Participate in compliance walkthrough of the Manufacturing floor and other assigned areas. Partner with Manufacturing to ensure compliance in Manufacturing operations. Review and approve Master Batch Records and other supporting documents. Execute process performance and product quality monitoring programs. Alert senior management of potential deviations or compliance risks. Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements. Provide input on communication as to the status of deliverables to customers, management, and stakeholders. Assist with developing training regarding QMS process or system changes. Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records). Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement. Lifecycle management of the stability program for clinical and commercial products Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones. Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements. Ensure that stability studies are executed according to protocol. Review, verification, disposition, and archival of stability study data for assigned programs. Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution. Interpretate stability results to support expiry, trending, and conditions of products. Support product stability related content in regulatory submission, including responses to questions and post-marketing. Who You Are: Bachelor's Degree biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate's degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience. Strong attention to detail Ability to collaborate and communicate cross-functionally Why Join Us: Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow. Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life (hybrid model). Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged. Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas: We don't just talk about thinking outside the box, we throw the box away. If you've got ideas, we want to hear them. Are You Still Curious? If you've read this far, then chances are you've got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you, and how it will shape the future of Just-Evotec. Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec! The base pay range for this position at commencement of employment is expected to be $65,000 to $90,000; Base salary offered may vary depending on the individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

Job Title: QA Associate Reports To: Senior Manager, QA About Us: At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged, it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: We're looking for a passionate and curious QA Associate to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing. This role works collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below. What You'll Do: Review executed Manufacturing Batch Records. Participate in compliance walkthrough of the Manufacturing floor and other assigned areas. Partner with Manufacturing to ensure compliance in Manufacturing operations. Review and approve Master Batch Records and other supporting documents. Execute process performance and product quality monitoring programs. Alert senior management of potential deviations or compliance risks. Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements. Provide input on communication as to the status of deliverables to customers, management, and stakeholders. Assist with developing training regarding QMS process or system changes. Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records). Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement. Lifecycle management of the stability program for clinical and commercial products Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones. Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements. Ensure that stability studies are executed according to protocol. Review, verification, disposition, and archival of stability study data for assigned programs. Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution. Interpretate stability results to support expiry, trending, and conditions of products. Support product stability related content in regulatory submission, including responses to questions and post-marketing. Who You Are: Bachelor's Degree biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate's degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience. Strong attention to detail Ability to collaborate and communicate cross-functionally Why Join Us: Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow. Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life (hybrid model). Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged. Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success. A Place for Big Ideas: We don't just talk about thinking outside the box, we throw the box away. If you've got ideas, we want to hear them. Are You Still Curious? If you've read this far, then chances are you've got a curious mind, just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you, and how it will shape the future of Just-Evotec. Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec! The base pay range for this position at commencement of employment is expected to be $65,000 to $90,000; Base salary offered may vary depending on the individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

The position description is a guide to the critical duties and essential functions of the job, not an all-inclusive list of responsibilities, qualifications, physical demands, and work environment conditions. Position descriptions are reviewed and revised to meet the changing needs of the organization. TITLE: Clinical Documentation Specialist RN JOB OVERVIEW: The Clinical Documentation Specialist position facilitates accurate documentation for severity of illness and quality in the medical record. This involves extensive record review, interaction with physicians, health information management professionals, and nursing staff. Active participation in team meetings and education of staff in the documentation improvement process is a key role. DEPARTMENT: Health Information Management HOURS OF WORK: Days Monday - Friday. RESPONSIBLE TO: Manager, Clinical Documentation Improvement PREREQUISITES: * Current unrestricted WA State Registered Nurse license, required. * Bachelor's degree in Nursing, preferred. * Minimum five years recent clinical experience as an RN working in an acute care setting or with experience in Utilization Review * Pass a pre-hire Clinical Exam with a minimum score of 70% * Effective communication with Providers QUALIFICATIONS: * Knowledge of hospital clinical practice standards for physicians and other health care providers. * Knowledge of ancillary service departments, quality control and safety standards. * Critical thinking, problem solving and deductive reasoning skills. * Familiarity with health care audit and research design. * Knowledge of Pathophysiology and Disease process. * Functional knowledge of DRG coding systems. * Working experience with Utilization Review activities and general knowledge of JCAHO, PRO, HCFA, and other regulatory bodies. * Knowledge of third-party payer review, reimbursement systems and utilization monitoring requirements for acute care facilities. * Meet productivity guidelines. * Ability to learn/develop the skills necessary to perform and meet goal standards * Organizational, analytical, writing, and interpersonal skills * Dependable, self-directed, and pleasant * Critical thinking, problem solving and deductive reasoning skills * Knowledge of Pathophysiology and Disease Process * Basic Computer skills - familiarity with Windows based software programs * Knowledge of regulatory environment * Understand and support documentation strategies (upon completion of training) * Knowledge of Core Measure and Patient Safety Indicators (upon completion of training) UNIQUE PHYSICAL/MENTAL DEMANDS, ENVIRONMENT AND WORKING CONDITIONS: See Generic for Administrative Partner. PERFORMANCE RESPONSIBILITIES: A. Generic Job Functions: See Generic Job Description for Administrative Partner. B. Essential Responsibilities and Competencies * Reviews EMR for completeness and accuracy for severity of illness and quality using the documentation strategies. * Accurate and timely record review. * Recognize opportunities for documentation improvement. * Initiates severity worksheet for inpatients. * Formulate clinically credible documentation clarifications. * Request documentation clarifications as appropriate for SOI, Core Measures, and Patient Safety. * Effective and appropriate communication with physicians. * Timely follow up on all cases and resolution of those with clinical documentation clarifications. * Communicates with HIM staff and resolves discrepancies. * Accurate input of data for reconciliation of case. * Provide necessary information and education to physicians and staff to facilitate the appropriate documentation goals. * Identify any barriers to completion of documentation goals with appropriate interventions. * Review of regulations and coding guidelines through seminars, meetings, and materials. * In cooperation with the director of PFS/HIM, present education sessions to physicians and other VMC providers regarding documentation regulations and chart audit findings. * Maintains confidentiality of all accessible patient financial or medical records information. * Demonstrates the awareness of the importance of cost containment for the department. Provide suggestions regarding process or quality improvement opportunities to department manager. * Other duties as assigned to facilitate accurate, timely patient account management. Date Created: 5/18, updated 7/22 Grade: NC11 FLSA: E Cost Center: 8490 Job Qualifications: PREREQUISITES: * Current unrestricted WA State Registered Nurse license, required. * Bachelor's degree in Nursing, preferred. * Minimum five years recent clinical experience as an RN working in an acute care setting or with experience in Utilization Review * Pass a pre-hire Clinical Exam with a minimum score of 70% * Effective communication with Providers QUALIFICATIONS: * Knowledge of hospital clinical practice standards for physicians and other health care providers. * Knowledge of ancillary service departments, quality control and safety standards. * Critical thinking, problem solving and deductive reasoning skills. * Familiarity with health care audit and research design. * Knowledge of Pathophysiology and Disease process. * Functional knowledge of DRG coding systems. * Working experience with Utilization Review activities and general knowledge of JCAHO, PRO, HCFA, and other regulatory bodies. * Knowledge of third-party payer review, reimbursement systems and utilization monitoring requirements for acute care facilities. * Meet productivity guidelines. * Ability to learn/develop the skills necessary to perform and meet goal standards * Organizational, analytical, writing, and interpersonal skills * Dependable, self-directed, and pleasant * Critical thinking, problem solving and deductive reasoning skills * Knowledge of Pathophysiology and Disease Process * Basic Computer skills - familiarity with Windows based software programs * Knowledge of regulatory environment * Understand and support documentation strategies (upon completion of training) * Knowledge of Core Measure and Patient Safety Indicators (upon completion of training)

Job Description A successful biotech company is looking for an experienced and detail-oriented Associate to join our Quality Assurance team on site in Bothell, WA. Unfortunately at this time no relocation or visa sponsorship provided. At ELITechGroup, we are committed to supporting health systems globally. We take pride in our team and strive to maintain a work environment that is both professionally challenging and personally fulfilling. As a valued member of our team, you would contribute to the manufacturing and distribution of in vitro diagnostic products to clients in over 100 countries. You will have the opportunity to work alongside some of the brightest minds in the industry, as our team is dedicated to solving problems and delivering excellent products. This position is ideal for someone with some experience in the biotech industry and audits, who takes pride in learning all aspects of the job and adhering to procedures and standards. You will receive guidance from a supportive team that will ensure you are trained and capable of performing your responsibilities effectively. The primary focus of the QA Associate role is to support commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications. Summary With direction, has part of the responsibility for ELITechGroup MDx Quality Assurance activities. Essential Duties and Responsibilities Performs review of manufacturing batch records, enter information in Disposition Log, filing of batch records, and ensure the records are complete and stored in a manner where they are readily retrievable. Performs finished product inspection. Performs review and approval of labels. Reviews SPEC sheets, enter information in Disposition Log, file. Assists QA with the tracking and/or completion of CAPAs and Customer Complaints. Assists QA with the tracking and/or completion of NCRs, OOSs, TMPs. Assigns part numbers. Reviews, tracks, and files training forms. Ensures the training log is updated. Reviews calibration/maintenance records, update tracking log, file. Ensure the records are complete and stored in a manner where they are readily retrievable. Participates during audits (FDA, ISO, vendor) Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary. Other duties and task as assigned. Competencies To perform the job successfully, an individual should demonstrate the following competencies: Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values. Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality. Written Communication - writes clearly and informatively; able to read and interpret written information. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. Bachelor's degree (B.A. or B.S.), or equivalent combination of education and experience. Minimum of 2 years' experience in working in an FDA or ISO regulated environment or equivalent training. Knowledge of ISO 13485, ISO 9001, and FDA QSR preferred Job Posted by ApplicantPro

In this role, you will be responsible for the preparation and review of required procedures, documentation, and retention practices, supporting inspections, and promoting continuous improvement and compliance efforts. You will support global operations across PharmSci and partner lines to align goals and implement effective quality system solutions. Your collaboration and implementation of practices will enhance efficiencies throughout quality procedures and documentation. Your contributions will be vital in achieving team goals and ensuring timely completion of important deliverables. Your innovative communication skills will facilitate consensus between teams, ultimately enabling customers and patients to receive the medicines they need when they need them. Responsibilities + Perform procedural administration activities within the Global Documentation Management System. + Collaborate with PharmSci and PGS business lines to develop, implement, and manage procedures, documentation, and records. + Support management of Active libraries and other documentation systems to ensure control of physical and electronic records. + Manage inventory of records within the Central Index of Company Records (CICR) system for record creation, management, retention, and disposal. + Partner with the Enterprise Records and Information Management (eRIM) team to align with record retention policies and legal holds. + Collaborate with off-site teams to manage the lifecycle of company records and ensure retrieval processes for audits and inspections. + Provide technical writing, editing, and design support to team members and site departments. + Work closely with project teams to ensure documents are accurate, consistent, and compliant with internal standards and regulatory guidelines. + Support equipment change controls, manage calibration/PM schedules, and coordinate associated documentation. Essential Skills + 1+ years of experience. + Understanding of cGMP, Data Integrity, and ALCOA principles. + Strong organizational and communication skills. + Proficiency in word processing and document formatting. + Expertise in Microsoft Office applications (Word, Excel, PowerPoint, Visio). Additional Skills & Qualifications + Relevant pharmaceutical experience. + Demonstrated technical writing experience is desirable. + Strong project management skills. Work Environment The role involves collaborating with various teams and managing documentation systems within a structured environment. Familiarity with technologies such as electronic document management systems (EDMS) and adherence to FDA regulations are important. The work involves both physical and electronic documentation management, requiring attention to detail and organizational skills. We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following: · Medical, dental & vision · 401(k)/Roth · Insurance (Basic/Supplemental Life & AD&D) · Short and long-term disability · Health & Dependent Care Spending Accounts (HSA & DCFSA) · Transportation benefits · Employee Assistance Program .Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & Location This is a Contract position based out of Bothell, WA. Pay and Benefits The pay range for this position is $24.00 - $28.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Bothell,WA. Application Deadline This position is anticipated to close on Jan 20, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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 *********************

A successful biotech company is looking for an experienced and detail-oriented Associate to join our Quality Assurance team on site in Bothell, WA. Unfortunately at this time no relocation or visa sponsorship provided. At ELITechGroup, we are committed to supporting health systems globally. We take pride in our team and strive to maintain a work environment that is both professionally challenging and personally fulfilling. As a valued member of our team, you would contribute to the manufacturing and distribution of in vitro diagnostic products to clients in over 100 countries. You will have the opportunity to work alongside some of the brightest minds in the industry, as our team is dedicated to solving problems and delivering excellent products. This position is ideal for someone with some experience in the biotech industry and audits, who takes pride in learning all aspects of the job and adhering to procedures and standards. You will receive guidance from a supportive team that will ensure you are trained and capable of performing your responsibilities effectively. The primary focus of the QA Associate role is to support commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications. Summary With direction, has part of the responsibility for ELITechGroup MDx Quality Assurance activities. Essential Duties and Responsibilities * Performs review of manufacturing batch records, enter information in Disposition Log, filing of batch records, and ensure the records are complete and stored in a manner where they are readily retrievable. * Performs finished product inspection. * Performs review and approval of labels. * Reviews SPEC sheets, enter information in Disposition Log, file. * Assists QA with the tracking and/or completion of CAPAs and Customer Complaints. * Assists QA with the tracking and/or completion of NCRs, OOSs, TMPs. * Assigns part numbers. * Reviews, tracks, and files training forms. Ensures the training log is updated. * Reviews calibration/maintenance records, update tracking log, file. * Ensure the records are complete and stored in a manner where they are readily retrievable. * Participates during audits (FDA, ISO, vendor) * Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary. * Other duties and task as assigned. Competencies To perform the job successfully, an individual should demonstrate the following competencies: Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values. Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality. Written Communication - writes clearly and informatively; able to read and interpret written information. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. * Bachelor's degree (B.A. or B.S.), or equivalent combination of education and experience. * Minimum of 2 years' experience in working in an FDA or ISO regulated environment or equivalent training. * Knowledge of ISO 13485, ISO 9001, and FDA QSR preferred

A successful biotech company is looking for an experienced and detail-oriented Associate to join our Quality Assurance team on site in Bothell, WA. Unfortunately at this time no relocation or visa sponsorship provided. At ELITechGroup, we are committed to supporting health systems globally. We take pride in our team and strive to maintain a work environment that is both professionally challenging and personally fulfilling. As a valued member of our team, you would contribute to the manufacturing and distribution of in vitro diagnostic products to clients in over 100 countries. You will have the opportunity to work alongside some of the brightest minds in the industry, as our team is dedicated to solving problems and delivering excellent products. This position is ideal for someone with some experience in the biotech industry and audits, who takes pride in learning all aspects of the job and adhering to procedures and standards. You will receive guidance from a supportive team that will ensure you are trained and capable of performing your responsibilities effectively. The primary focus of the QA Associate role is to support commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications. Summary With direction, has part of the responsibility for ELITechGroup MDx Quality Assurance activities. Essential Duties and Responsibilities Performs review of manufacturing batch records, enter information in Disposition Log, filing of batch records, and ensure the records are complete and stored in a manner where they are readily retrievable. Performs finished product inspection. Performs review and approval of labels. Reviews SPEC sheets, enter information in Disposition Log, file. Assists QA with the tracking and/or completion of CAPAs and Customer Complaints. Assists QA with the tracking and/or completion of NCRs, OOSs, TMPs. Assigns part numbers. Reviews, tracks, and files training forms. Ensures the training log is updated. Reviews calibration/maintenance records, update tracking log, file. Ensure the records are complete and stored in a manner where they are readily retrievable. Participates during audits (FDA, ISO, vendor) Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary. Other duties and task as assigned. Competencies To perform the job successfully, an individual should demonstrate the following competencies: Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values. Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality. Written Communication - writes clearly and informatively; able to read and interpret written information. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. Bachelor's degree (B.A. or B.S.), or equivalent combination of education and experience. Minimum of 2 years' experience in working in an FDA or ISO regulated environment or equivalent training. Knowledge of ISO 13485, ISO 9001, and FDA QSR preferred

In this role, you will be responsible for the preparation and review of required procedures, documentation, and retention practices, supporting inspections, and promoting continuous improvement and compliance efforts. You will support global operations across PharmSci and partner lines to align goals and implement effective quality system solutions. Your collaboration and implementation of practices will enhance efficiencies throughout quality procedures and documentation. Your contributions will be vital in achieving team goals and ensuring timely completion of important deliverables. Your innovative communication skills will facilitate consensus between teams, ultimately enabling customers and patients to receive the medicines they need when they need them. Responsibilities * Perform procedural administration activities within the Global Documentation Management System. * Collaborate with PharmSci and PGS business lines to develop, implement, and manage procedures, documentation, and records. * Support management of Active libraries and other documentation systems to ensure control of physical and electronic records. * Manage inventory of records within the Central Index of Company Records (CICR) system for record creation, management, retention, and disposal. * Partner with the Enterprise Records and Information Management (eRIM) team to align with record retention policies and legal holds. * Collaborate with off-site teams to manage the lifecycle of company records and ensure retrieval processes for audits and inspections. * Provide technical writing, editing, and design support to team members and site departments. * Work closely with project teams to ensure documents are accurate, consistent, and compliant with internal standards and regulatory guidelines. * Support equipment change controls, manage calibration/PM schedules, and coordinate associated documentation. Essential Skills * 1+ years of experience. * Understanding of cGMP, Data Integrity, and ALCOA principles. * Strong organizational and communication skills. * Proficiency in word processing and document formatting. * Expertise in Microsoft Office applications (Word, Excel, PowerPoint, Visio). Additional Skills & Qualifications * Relevant pharmaceutical experience. * Demonstrated technical writing experience is desirable. * Strong project management skills. Work Environment The role involves collaborating with various teams and managing documentation systems within a structured environment. Familiarity with technologies such as electronic document management systems (EDMS) and adherence to FDA regulations are important. The work involves both physical and electronic documentation management, requiring attention to detail and organizational skills. We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following: * Medical, dental & vision * 401(k)/Roth * Insurance (Basic/Supplemental Life & AD&D) * Short and long-term disability * Health & Dependent Care Spending Accounts (HSA & DCFSA) * Transportation benefits * Employee Assistance Program .Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & Location This is a Contract position based out of Bothell, WA. Pay and Benefits The pay range for this position is $24.00 - $28.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Bothell,WA. Application Deadline This position is anticipated to close on Jan 19, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.