Quality assurance specialist jobs in Marysville, 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 *********************

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!

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.

We are a manufacturer of structural parts for the leading original equipment manufacturers (OEM's) in the large business and regional jet markets. Our experience and capabilities span multiple segments of an aircraft, including the engine pylon, struts, wing box, wings, wheel well, and the interior. Our success is based on utilizing proprietary manufacturing techniques to manufacture high quality complex parts through cost effective production. Given its breadth of capabilities and strong customer relationships, we have substantial content on the aviation industry's most popular aircraft. Job Description The Quality Assurance (QA) Manager coordinates the daily activities of the QA Department. The QA Manager provides leadership, training and supervision for all levels of QA Inspectors, as well as the ability to perform the duties of a QA Inspector. The QA Manager works with the Quality Engineering Department in regards to supporting their efforts and provides schedule of activities that they may need to co-ordinate with. What will my responsibilities include? Assigns or oversees the assignment of daily, weekly and monthly tasks to QA leads and inspectors to ensure that workload is distributed to meet production priorities. Provides resource planning and headcount requirements to the Director of Quality as needed. Works with Operations to create and formulate plans to drive product quality throughout the manufacturing process. Supervises QA Leads and Inspectors, including problem-solving, scheduling, training, counseling, and completing performance reviews. Acts as a technical focal for reading and interpreting aerospace manufacturing drawings, including tolerances, customer specifications and technical requirements. Able to document product acceptance/rejection on manufacturing order and processes appropriate rejection documentation. Able to utilize MRP system to run reports and complete tasks as necessary. Verifies visual and dimensional conformance of manufactured & purchased products to engineering specifications. Other duties as assigned. What key skills and experience do I need? Leadership: Ability to train, mentor, and assist less-experienced QA personnel and staff from other departments in skills, abilities and knowledge related to quality inspection and customer requirements. Supervision: Directs and manages staff to ensure that departmental goals are met. Attention to detail: Recognizes and identifies deviations from requirements. Communication: Effectively communicates verbally and in writing. Customer focus: Anticipates internal and external customer needs, gives high priority to customer satisfaction and service. Provides information and results accurately, courteously, in a timely manner. Organization: Keeps working area neat and organized. Arrives on time to work and works to meet deadlines efficiently Teamwork: Collaborates and cooperates with all departments and other inspectors to resolve issues. Knows when to ask for information and assistance, and assesses the long-term impact of decisions. Demonstrates a willing, positive, and proactive attitude. Company policy awareness: Understands and complies with company policies and guidelines as described in the Employee Handbook, the Employee Safety Manual and the Quality Management System. Complies with rules and procedures of a drug-free workplace. Qualifications Preferred : Minimum of 10 years QA experience in a regulated industry. Must possess the ability to make decisions based on fact. Ability to read & interpret Engineering Drawings and models. Working knowledge & application of GD&T. Previous supervisory experience. Hands-on inspection experience in the aerospace industry. Trade school or college courses or equivalent in related fields (e.g., CMM, blueprint reading, GD&T). Additional Information Why join Senior Aerospace AMT/Damar? We are committed to continuous sustainable growth through superior customer satisfaction. We are dedicated to operating in an ethical, safe, and environmentally responsible manner while providing a rewarding work environment for our employees. Our mission is supported by a culture of teamwork, continuous improvement, and strategic technology investments. Salary Offering: $100,000 annually to $121,000 annually Shift: Monday - Friday (exempt role) Benefit Offerings Senior Aerospace AMT/Damar offers eligible employees (and eligible family members): Medical, Dental, Vision Health Savings Account Supplemental Benefits Basic Life Insurance Voluntary Employee, Spouse or Child Life Insurance, Long-term Disability Insurance Employee Assistance Program Shift Premiums for Weekend Shifts - work 33 hours, paid for 40 (weekend night shift) or work 36 hours, paid for 40 (weekend day shift) Shift Differentials - $4.00 per hour (weekday night shift), $2.00 per hour (weekend day shift), $4.00 per hour (weekend night shift) Eligible employees are also offered 401k, PTO, 80 hours of paid holiday per calendar year, and other compensation (as applicable). Senior Aerospace AMT/Damar is an equal opportunity employer. Trade Compliance Statement Access to our facilities is restricted under the International Traffic in Arms Regulations (ITAR) and/or the Export Administration Regulations (EAR) to U.S. Persons (U.S. Citizens, lawful permanent residents, U.S. Nationals, U.S. refugees, asylees, or temporary residents under amnesty provisions ), and to properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes. Additionally, potential employee names will be screened against the Consolidated Screening List (maintained by the United States government) to determine eligibility to receive controlled technical data. To ensure there is no unexpected delay to your start date with our Company and due to the potential need to obtain an export license, we would like to promptly assess whether such a license is needed to access our facility and/or systems. Such licenses can take several weeks/months to obtain from the U.S. Government. Our Trade Compliance department may reach out to you with a Licensing Assessment form, which we request you kindly complete and return as soon as possible. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. EOE M/F/D/V/VEVRAA Federal Contractor

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

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

You will serve as a QUALITY ASSURANCE SPECIALIST in the Production Quality Division, Production Resources Department of PSNS and IMF. You will function as the Department Problem Resolution Chairperson who conducts/facilitates Problem Resolution Investigations and prepares internal and external Shipyard reports. You will provide guidance to the problem resolution team members regarding their performance objectives to analyze undesirable or unplanned events that occur in and around the Shipyard. You will coordinate with various department divisions to obtain required report concurrence signatures and distribute reports and ensure the generation of consolidated action tracking system (CATS) items for actions. You will validate completion of corrective actions through monitoring and review of the CATS program. You will conduct research to determine and interpret higher and local level process and procedure requirements in order to produce audit and surveillance plans and to conduct audits and surveillances to assess compliance as required. You will input findings, corrective actions, and root cause data into the applicable databases (CATS, QPS, etc.). You will present audit and surveillance observations and/or findings/analysis to appropriate department and PSNS and IMF management. Requirements Help Conditions of employment Must be a US Citizen. Must be determined suitable for federal employment. Must participate in the direct deposit pay program. New employees to the Department of the Navy will be required to successfully pass the E-Verify employment verification check. To learn more about E-Verify, including your rights and responsibilities, visit e-verify.gov Generally, current federal employees applying for GS jobs must serve at least one year at the next lower grade level. This requirement is called time-in-grade. Time-in-grade requirements must be met by the closing date of this announcement. Within the Department of Defense (DoD), the appointment of retired military members within 180 days immediately following retirement date to a civilian position is subject to the provisions of 5 United States Code 3326. Males born after 12-31-59 must be registered for Selective Service. This is a bargaining unit position. You will be required to obtain and maintain an interim and/or final security clearance prior to entrance on duty. Failure to obtain and maintain the required level of clearance may result in the withdrawal of a job offer or removal. You will be required to wear personal protective equipment such as helmets, gloves, coveralls, glasses, goggles, respirators and safety shoes continuously for the duration of the work shift. This position may require travel from normal duty station to CONUS and OCONUS and may include remote or isolated sites. You must be able to travel on military and commercial aircraft for extended periods of time. Qualifications GS-12: Your resume must demonstrate at least one year of specialized experience at or equivalent to the GS-11 grade level or pay band in the Federal service or equivalent experience in the private or public sector evaluating, developing, and executing quality assurance program processes or procedures utilizing causal analysis techniques, identifying operational or procedural deficiencies, and recommending corrective actions to prevent recurrence and ensure shipyard projects meet quality requirements. GS-11: Your resume must demonstrate at least one year of specialized experience at or equivalent to the GS-09 grade level or pay band in the Federal service or equivalent experience in the private or public sector analyzing problems and processes utilizing causal analysis techniques, identifying operational or procedural deficiencies, and recommending corrective actions to prevent recurrence and ensure shipyard projects meet quality requirements. Additional qualification information can be found from the following Office of Personnel Management web site: Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. Education In lieu of specialized experience, you may qualify with the following education or combination of both education and experience: Substitution of education for GS-11: Education may be substituted for specialized experience as follows: Completion of Ph.D. or equivalent doctoral degree (Such education must demonstrate the knowledge, skills, and abilities necessary to do the work.) ~OR~ 3 full years of progressively higher level graduate education leading to such a degree (Such education must demonstrate the knowledge, skills, and abilities necessary to do the work.) ~OR~ LL.M., if related (Such education must demonstrate the knowledge, skills, and abilities necessary to do the work.) ~OR~ A combination of experience and graduate education as described above that equates to one year of experience. A transcript must be submitted with your application if qualifying using education. See Required Documents for additional information. Additional information This position is covered by the Department of Defense Priority Placement Program. Additional vacancies may be filled by this announcement. A tentative offer of employment will be rescinded if the selectee fails to meet the pre-employment requirements, including failure to report to any of the scheduled appointments. During the application process you will have the ability to opt-in to make your resume available to hiring managers in the agency who have similar positions in the local commuting area. Depending on the hiring organization and the position being filled, job requirements (e.g., security clearance, travel, drug testing, financial disclosure filing, bargaining unit status, etc.) may vary. Other hiring managers filling similar positions may offer relocation expense reimbursement and/or may offer recruitment incentives for new employees, depending on funding availability and in accordance with policy. If you opt-in and are referred on a certificate, your resume will be available to other hiring managers for 180-days from the date the job announcement closes. Opting in does not impact your application for this announcement, nor does it guarantee further consideration for additional positions. Federal annuitant information: The selection of an annuitant is subject to the Department of Defense and Department of the Navy policy on the employment of annuitants. Policy information may be found at: PPP applicants will be placed at the FPL, if determined Well Qualified (WQ). To receive priority consideration, the FPL must be the same grade level or equivalent of the retained grade or the grade held immediately prior to separation. ICTAP Applicants: To be considered well-qualified and exercise selection priority as an ICTAP candidate, displaced Federal employees must satisfy all qualification requirements for the position and receive a rating in the highly qualified category (score 85) or higher. ICTAP candidates must provide copies of all of the following documentation at the time of application: 1) agency notice; 2) most recent performance appraisal; and 3) most recent SF-50 or notification of personnel action that includes position, grade level, and duty location. Applicants who do not provide this documentation will not receive consideration as an ICTAP candidate. For more information about ICTAP eligibility please review the following link: Military Spouse Preference applicants will be placed at the highest grade for which they have applied and are determined Best Qualified (BQ). A BQ military spouse possesses knowledge, skills, abilities, and competencies comparable to others who meet the competitive referral criteria for the specific position. This position is subject to work an uncommon tour, including nights, weekends, and holidays to meet mission requirements. Overtime or night differential pay and/or unusual duty hours may be required. Vacancies filled from this announcement may be filled at any grade level listed. If selected below the full performance level, you may be noncompetitively promoted to the next higher grade level after meeting all regulatory requirements, and upon the recommendation of management. Promotion is neither implied nor guaranteed. Expand Hide additional information Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. Benefits Help A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new window Learn more about federal benefits. Review our benefits Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

Company: The Boeing Company Boeing Defense, Space and Security (BDS) has exciting opportunities for Quality Systems Specialists (Associate, Experienced or Senior) to support the E-7A program quality program in Birmingham, UK! This is a Long-Term Assignment to Birmingham, UK for up to 18 months. Relocation/assignment benefits to the international location will be provided. This position will be primarily located in Tukwila, WA providing long term support in Birmingham, UK supporting material review and nonconformance reviews utilizing root cause processes (RCCA) and corrective action. Successful candidates will have experience working in a quality manufacturing environment with preference for a strong background working with MRB activities and processes. Position Responsibilities: 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. Basic Qualifications (Required Skills/Experience): More than 1 year of experience in Quality Management Systems (QMS). More than 1 year in data analysis and Root Cause Corrective Action (RCCA). More than 3 years of using Microsoft Word, PowerPoint, Outlook, and Excel. Preferred Qualifications (Desired Skills/Experience): Level 3: More than 3 years of related work experience or an equivalent combination of education and experience. Level 4: More than 5 years of related work experience or an equivalent combination of education and experience. Experience with MRB processes and/or investigations. Aerospace, Fabrication, or Manufacturing experience. Bachelor's Degree or higher. Aerospace, Fabrication, or Manufacturing experience. Experience working with (MES) Manufacturing Execution System. Experience in working defect reduction strategies within a cross-functional environment. Experience in performing and coaching root cause analysis and problem solving for all levels of leadership. Long-term Assignment details Candidate must be able to obtain a work visa, depending on requirements of the country. Candidate must be able to meet the cultural requirements of the country, as applicable. Employment is contingent on the candidate's ability to satisfy all labor and immigration formalities of the country. 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. 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 for associate level (Level 2): USD 77,350 -104,650 Summary pay range for experienced level (Level 3): USD 94,350 - 127,650 Summary pay range for senior level (Level 4): USD 116,450 - 157,550 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)

Quality Assurance - Records Management Specialist Schedule: Sunday - Thursday The Quality Assurance - Records Management Specialist supports cGMP Document Control operations. This role focuses on receiving, reconciling, scanning, archiving, and retaining GMP records to ensure compliance with regulatory standards. Key Responsibilities * Organize cGXP controlled document files within the Document Center; ensure records are retrievable and archived as needed. * Assist with Document Center Archive room activities. * Execute processes for identifying, collecting, distributing, and filing controlled documents. * Follow SOPs and work instructions for document approval, effective dates, training workflows, and archiving. * Support internal/external audits and regulatory inspections, including document retrieval and auditor escorting. * Manage insurance and reconciliation of controlled forms and logbooks. Qualifications * Education: * Bachelor's degree preferred (Library Science a plus). * High school diploma/associate degree with equivalent experience considered. * Experience: * Minimum 3 years in document control/records management within a cGMP/FDA-regulated environment. * Familiarity with FDA/EMA regulations in biopharmaceutical or cell therapy manufacturing. * Skills: * Strong knowledge of cGMPs and domestic regulatory requirements. * Experience with Part 11 compliance for scanning and electronic archiving. * Proficiency in MS Office (Word, Excel, Visio, Adobe) and Quality Systems (Document Management System, Quality Management System). * Ability to prioritize, multitask, and troubleshoot in a fast-paced environment. * Excellent communication and customer service skills. Job Type & Location This is a Contract position based out of Bothell, WA. Pay and Benefits The pay range for this position is $36.02 - $43.95/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 Dec 5, 2025. 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.

Our Logistics Documentation Specialist will play a supporting role in the global seafood sales team of O'Hara Corporation by preparing domestic and international export shipping documents accurately and promptly for the smooth movement by ocean freight, rail and trucks. This position collaborates with customers, sales teams, shipping companies and government agencies to ensure documents are completed in a timely manner and customers' payments are received on time. The ideal person for this job is passionate about O'Hara Corporation's core values of Excellence, Integrity, Innovation and Passion. Essential Duties & Job Functions: Enter production data from each fishing vessel into in-house database for commercial invoice, packing list and certificate of origin Enter production data into USDC Seafood Inspection Program (SIP) online database to generate export health certificates, certificates of origin, IUU catch certificates Provide shipment information to the shipping companies for bill of lading Create FedEx shipments and mail original shipping documentation to our international based customers Proactively communicate with customers regarding shipping documents and payment timing to avoid demurrage at destination ports Monitor cargo vessel schedules to track shipping document status to ensure timely payments from customers Drive to Ballard, Fremont and Sand Point occasionally for document pickup Provide other office administrative assistance as needed Work Schedule: Monday - Friday 8 a.m. - 4:30 p.m. in-office. Occasional overtime/weekend work as necessary Requirements Strong Microsoft Office skills Minimum five years of previous experience in an office support role High degree of accuracy and organization Ability to interact and communicate positively and professionally in person, on the phone, and in writing Strong sense of job responsibility Ability to prioritize tasks in a dynamic environment Prompt and reliable attendance Valid driver's license Preferred Skills and Experience: 3+ years of seafood domestic and export/logistics documentation experience to China, Japan, Korea, EU countries Experience with USDC Seafood Inspection Program (SIP) database Physical Requirements: Physical and technical requirements that meet the standards of O'Hara Corporation Infrequent lifting up to 25lbs Frequent walking and standing for periods exceeding one hour Frequent keyboard use and sitting at a desk Frequent bending, twisting and reaching. Benefits Medical, vision and dental insurance is offered to employees and qualified dependents if elected If elected, 401k employee contributions begin 60 days from start date with employer match after one year of employment Compensation: Salary Non-Exempt $60k-$85k DOE O'Hara Corporation 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 characteristics 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.

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)

The QA Safety Evaluator supports management in the development, implementation, and continuous improvement of an effective Quality Management System (QMS) and site-level Occupational Safety and Health Program. This role ensures compliance with customer requirements, regulatory standards, and internal policies by maintaining quality documentation, conducting audits, and driving process improvements. The specialist also coordinates safety initiatives, training, and hazard mitigation across the site. Responsibilities: Quality Assurance: Support the planning, development, and implementation of the Quality Management System (QMS). Assist in the creation and maintenance of an approved Quality Manual in compliance with the contract Statement of Work (SOW) and QMS standards. Coordinate the development and revision of Work Instructions (WIs) and Standard Operating Procedures (SOPs) for all QMS elements. Schedule and support quality assurance (QA) audits and inspections. Conduct or participate in technical and special inspections as required. Maintain documentation of site quality audits, including nonconformity reports and corrective/preventive action plans. Analyze audit findings, trends, and key performance metrics to identify and implement process improvements. Provide support for Government-led quality audits. Safety Program: Coordinate and implement Occupational Safety and Health Program requirements at the site level. Ensure compliance with applicable regulatory bodies (e.g., OSHA, EPA, U.S. Navy, etc.). Identify and mitigate physical and procedural hazards in the workplace. Coordinate and/or deliver required safety training for employees. Advise site management on hazard assessments, control measures, regulatory compliance, and safety initiatives. Serve as the focal point for site safety inspections, reporting, and analysis. Manage incident reporting and investigation; assist in corrective action planning and implementation. Conduct workplace inspections, assessments, and maintain related records. Develop strategies to improve overall site safety and promote a proactive safety culture. Follow injury management procedures and coordinate treatment with local medical facilities and site safety leadership. Perform root cause analysis and provide guidance to site management on corrective actions. Qualifications: Bachelor's degree in quality assurance, Occupational Safety, Environmental Science, Engineering, or a related field. 5+ years of experience in quality and/or safety program administration. Knowledge of QMS standards (e.g., ISO 9001) and occupational safety regulations (e.g., OSHA, EPA). Experience with audit processes, technical inspections, and regulatory compliance. Strong analytical, organizational, and communication skills. Ability to work independently and collaboratively with multidisciplinary teams. Secret Clearance required Benefits: Sayres Defense offers a competitive benefits package including medical, dental, and vision insurance, retirement plan options, paid time off, and additional employee support programs. Eligibility and specific offerings may vary based on position, location, and other factors. The position description is only meant to be a representative summary of the major responsibilities and accountabilities performed by the incumbents of this position. The incumbents may be requested to perform position-related tasks other than those stated in this description. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, gender identity, disability or veteran status. At Sayres, our employees enjoy an atmosphere conducive to realizing their potential through personal and professional development while simultaneously exceeding customers' expectations. We offer a broad spectrum of technical, engineering and administrative services including acquisition, financial and program management; fleet synthetic training; logistics; ship construction engineering; systems engineering and integration; wargaming; test and evaluation; security, counterintelligence and policy analysis. Sayres is headquartered in Washington, DC with offices throughout the United States and has a presence abroad. #cj

Job Description JRAD is seeking candidates for QA Safety Evaluators who support management in the development, implementation, and continuous improvement of an effective Quality Management System (QMS) and site-level Occupational Safety and Health Program. This role ensures compliance with customer requirements, regulatory standards, and internal policies by maintaining quality documentation, conducting audits, and driving process improvements. The specialist also coordinates safety initiatives, training, and hazard mitigation across the site. Roles/Responsibilities: Quality Assurance: Support the planning, development, and implementation of the Quality Management System (QMS). Assist in the creation and maintenance of an approved Quality Manual in compliance with the contract Statement of Work (SOW) and QMS standards. Coordinate the development and revision of Work Instructions (WIs) and Standard Operating Procedures (SOPs) for all QMS elements. Schedule and support quality assurance (QA) audits and inspections. Conduct or participate in technical and special inspections as required. Maintain documentation of site quality audits, including nonconformity reports and corrective/preventive action plans. Analyze audit findings, trends, and key performance metrics to identify and implement process improvements. Provide support for Government-led quality audits. Safety Program: Coordinate and implement Occupational Safety and Health Program requirements at the site level. Ensure compliance with applicable regulatory bodies (e.g., OSHA, EPA, U.S. Navy, etc.). Identify and mitigate physical and procedural hazards in the workplace. Coordinate and/or deliver required safety training for employees. Advise site management on hazard assessments, control measures, regulatory compliance, and safety initiatives. Serve as the focal point for site safety inspections, reporting, and analysis. Manage incident reporting and investigation; assist in corrective action planning and implementation. Conduct workplace inspections, assessments, and maintain related records. Develop strategies to improve overall site safety and promote a proactive safety culture. Follow injury management procedures and coordinate treatment with local medical facilities and site safety leadership. Perform root cause analysis and provide guidance to site management on corrective actions. Required Skills and Education: Bachelor's degree in quality assurance, Occupational Safety, Environmental Science, Engineering, or a related field. 5+ years of experience in quality and/or safety program administration. Knowledge of QMS standards (e.g., ISO 9001) and occupational safety regulations (e.g., OSHA, EPA). Experience with audit processes, technical inspections, and regulatory compliance. Strong analytical, organizational, and communication skills. Ability to work independently and collaboratively with multidisciplinary teams Security Clearance: Secret Clearance When you work for JRAD you will never be just a number. We put people before profits! JRAD is committed to the health and well-being of its employees. We offer more paid time off than the average company upon hire and the following benefits are available to all full-time employees: Health Insurance Dental Insurance Vision Insurance Life & Accidental Death and Dismemberment Insurance Section 125 Flexible Spending Accounts for unreimbursed medical & dependent day care Disability Insurance 401K Plan Tuition Reimbursement JRAD is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. The JRAD salary range for this position is a general guideline only and not a guarantee of compensation or salary. There are many factors considered when determining the compensation provided in an offer. These factors include, but are not limited to position responsibilities, education, experience, knowledge, skills, and contract terms and conditions. PLEASE NOTE: Once you apply, to ensure you continue to receive important updates on your application and status, please add JRAD to your approved email list and/or check your spam and junk mail often for updates.

. Join Lumen as a QA Associate for OTF Support on an independent contractor basis. 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

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

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

Quality Assurance - Records Management Specialist Schedule: Sunday - Thursday The Quality Assurance - Records Management Specialist supports cGMP Document Control operations. This role focuses on receiving, reconciling, scanning, archiving, and retaining GMP records to ensure compliance with regulatory standards. Key Responsibilities + Organize cGXP controlled document files within the Document Center; ensure records are retrievable and archived as needed. + Assist with Document Center Archive room activities. + Execute processes for identifying, collecting, distributing, and filing controlled documents. + Follow SOPs and work instructions for document approval, effective dates, training workflows, and archiving. + Support internal/external audits and regulatory inspections, including document retrieval and auditor escorting. + Manage insurance and reconciliation of controlled forms and logbooks. Qualifications + Education: + Bachelor's degree preferred (Library Science a plus). + High school diploma/associate degree with equivalent experience considered. + Experience: + Minimum 3 years in document control/records management within a cGMP/FDA-regulated environment. + Familiarity with FDA/EMA regulations in biopharmaceutical or cell therapy manufacturing. + Skills: + Strong knowledge of cGMPs and domestic regulatory requirements. + Experience with Part 11 compliance for scanning and electronic archiving. + Proficiency in MS Office (Word, Excel, Visio, Adobe) and Quality Systems (Document Management System, Quality Management System). + Ability to prioritize, multitask, and troubleshoot in a fast-paced environment. + Excellent communication and customer service skills. Job Type & Location This is a Contract position based out of Bothell, WA. Pay and Benefits The pay range for this position is $36.02 - $43.95/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 Dec 5, 2025. 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.

Job Description Our Logistics Documentation Specialist will play a supporting role in the global seafood sales team of O'Hara Corporation by preparing domestic and international export shipping documents accurately and promptly for the smooth movement by ocean freight, rail and trucks. This position collaborates with customers, sales teams, shipping companies and government agencies to ensure documents are completed in a timely manner and customers' payments are received on time. The ideal person for this job is passionate about O'Hara Corporation's core values of Excellence, Integrity, Innovation and Passion. Essential Duties & Job Functions: Enter production data from each fishing vessel into in-house database for commercial invoice, packing list and certificate of origin Enter production data into USDC Seafood Inspection Program (SIP) online database to generate export health certificates, certificates of origin, IUU catch certificates Provide shipment information to the shipping companies for bill of lading Create FedEx shipments and mail original shipping documentation to our international based customers Proactively communicate with customers regarding shipping documents and payment timing to avoid demurrage at destination ports Monitor cargo vessel schedules to track shipping document status to ensure timely payments from customers Drive to Ballard, Fremont and Sand Point occasionally for document pickup Provide other office administrative assistance as needed Work Schedule: Monday - Friday 8 a.m. - 4:30 p.m. in-office. Occasional overtime/weekend work as necessary Requirements Strong Microsoft Office skills Minimum five years of previous experience in an office support role High degree of accuracy and organization Ability to interact and communicate positively and professionally in person, on the phone, and in writing Strong sense of job responsibility Ability to prioritize tasks in a dynamic environment Prompt and reliable attendance Valid driver's license Preferred Skills and Experience: 3+ years of seafood domestic and export/logistics documentation experience to China, Japan, Korea, EU countries Experience with USDC Seafood Inspection Program (SIP) database Physical Requirements: Physical and technical requirements that meet the standards of O'Hara Corporation Infrequent lifting up to 25lbs Frequent walking and standing for periods exceeding one hour Frequent keyboard use and sitting at a desk Frequent bending, twisting and reaching. Benefits Medical, vision and dental insurance is offered to employees and qualified dependents if elected If elected, 401k employee contributions begin 60 days from start date with employer match after one year of employment Compensation: Salary Non-Exempt $60k-$85k DOE O'Hara Corporation 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 characteristics 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.

. Join Lumen as a QA Associate for Qualification Support on an independent contractor basis. 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