Senior FDA CAPA & Audit Lead - Inspection Readiness
Creative Solutions Services, LLC
Creative Solutions Services, LLC is actively seeking a qualified professional to lead FDA audit and inspection readiness activities in Bothell, Washington. The ideal candidate will have over 10 years of experience in Quality and Compliance, with strong hands-on experience in CAPA, FDA inspections, and regulatory compliance programs. This role entails mentoring staff, ensuring audit preparedness, and acting as the primary presenter during FDA interactions. Strong organizational and leadership skills are required. #J-18808-Ljbffr Creative Solutions Services, LLC
- Job Description Key Responsibilities Lead FDA audit and inspection readiness activities across the business. Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions. Act as the primary presenter/interface...Senior
$66 - $69.56 per hour
...documentation (Batch Records, Forms, etc), E-Systems deployment, inspection readiness, and training. The Associate Engineer will support product... ...for process improvements and operational efficiencies, and leads implementation efforts. Follows change‑management SOPs,...SeniorHourly payTemporary workWork at officeLocal areaMonday to Friday- ...Compliance. The selected candidate will lead Quality Systems and Compliance... ...regulations and health authority readiness. The role includes managing self-inspections and overseeing quality governance.... ..., extensive knowledge of GMP and audit processes, and proven leadership in...Senior
- Heidelberg Materials is seeking a Sales Manager for Ready Mix Concrete in Bothell, WA. The successful candidate will drive sales through strategic customer engagement, analyze market trends, and collaborate with teams to enhance service delivery. With 8+ years of leadership...Senior
$148k - $185k
...regulatory acceptability. Lead method qualification or validation... ...during regulatory agency inspections, partner audits, and internal GMP audits... ...in cross‑functional readiness activities to ensure the QC... ...deviations, Change Controls, and CAPAs associated with QC methods,...SuggestedLocal area- ...The Senior Human Resources Business Partner reports to the Manager... .... Supports and at times leads the implementation of HR programs... ...on team dynamics and change readiness. Coordinates and serves as the... ...expansive reading and visual inspection of employees, visitors or facility...SeniorWork at officeLocal areaFlexible hoursShift workAfternoon shift
$235.08k - $284.87k
...JuMP) in Bothell, WA. Lead Quality Systems and Compliance... ...Systems (Deviation, CAPA, Change Control,... ...authority compliance and inspection readiness; lead self‑inspection... .../third‑party audits; manage responses and... ...Extensive knowledge of FDA/EMA/PMDA and ROW GMP/ATMP...SeniorFull time$40 - $49 per hour
...Senior Maintenance Technician Position Type:... ...Responsibilities Lead the preventive maintenance... ...areas to support inspection readiness and operational excellence... ...and regulatory audits/inspections Contribute... ...5 years in a cGMP or FDA-regulated biotech, pharmaceutical...SeniorContract workFor contractorsWork at officeLocal area- ...Functions Supervision: Manage and lead a team which may include Associate... ...Ensure monthly physical property inspections are completed; partner with contractors/building... ...Ensure all vacant space is in "market ready" condition based on individual client requirements...Contract workFor contractorsWork at office
$92.4k - $126.5k
Job Title: Senior Scientist, Bioassay -... ...Process License Inspections and move toward commercial readiness. Responsibilities... ...during internal audits, client audits... ...authority inspections (FDA, EMA, PMDA).... ...& Compliance Lead and support GMP... ...OOT deviations, CAPAs and change controls...SeniorTemporary workMonday to FridayShift workDay shift- Novogradac & Company LLP is seeking a Senior Accountant in Bellevue, WA to manage tax and audit projects, supervise staff, and maintain client relationships. Ideal candidates will have a Bachelor's degree in accounting, 3-5 years of public accounting experience, and strong...SeniorFlexible hours
- Protingent is hiring a Quality Inspector/Senior Quality Inspector for a direct-hire role in Kirkland, WA. This position involves precision verification of mechanical components and ensuring quality throughout the production lifecycle. The successful candidate will work...Senior
- ...Immunopharma in Bothell, WA is seeking a Principal, Quality Control to lead analytical method validation for cell therapy products. This... ..., including method validation and supporting regulatory agency inspections. They will also drive continuous improvement initiatives within...Senior
- Senior Automation Engineer - Global MSAT Location... ...requirements. Lead continuous... ...integration issues. Manage CAPAs and change... ...integration, and MES readiness for new processes.... ...platforms. Knowledge of FDA CFR 21 Part 11... ...Participation in regulatory inspections or audit support....Senior
- jobr.pro, located in Bothell, Washington, is seeking a Principal, Quality Control to provide expertise in analytical method qualification for cell therapy products. The successful candidate will collaborate closely with various departments to ensure compliance and support...Senior
- Solid Rock Recruiting LLC is assisting a well-established CPA firm in Kirkland with their growth by seeking professionals for Audit Senior, Manager, and Director positions. Ideal candidates should have experience in public accounting and a strong understanding of audit...Senior
$148k - $185k
Lyell Immunopharma, Inc. is seeking a Principal, Quality Control to provide in-depth expertise in analytical method qualification and regulatory submission authoring for cell therapy products. This role involves close collaboration with various departments to support technology...Senior$24.52 - $43.71 per hour
Protingent is looking for a Senior or Specialist Quality Inspector in Kirkland, WA. This Direct Hire role involves precision inspection using complex measuring devices, troubleshooting mechanical tools, and validating First Article Inspection paperwork. Candidates must...SeniorHourly pay$66 - $69.56 per hour
Bristol Myers Squibb is looking for a Specialist I, Associate Engineer in Bothell, WA to support the production of personalized cell therapy products for clinical trials and commercial supply. In this role, you will act as a process subject matter expert, focusing on technology...SeniorHourly pay$85k - $90k
...Senior Facilities Technician Our client, a commercial real estate company, is looking for a Senior Facilities Technician to support... ...contractors, and scheduled maintenance services. Conduct roof inspections, repairs, and preventative maintenance. Maintain exterior lighting...SeniorFor contractors$24.03 - $31.75 per hour
A leading medical device company is seeking a Quality Inspector III to join its QA/RA Team in Bothell, WA. The role includes performing inspections on incoming parts and finished products, ensuring compliance with quality standards. Candidates should have a High School...Senior$41.98 - $52.47 per hour
Rivian seeks a Sr. Field Service Technician in Bothell, WA, passionate about enhancing customer service experiences. You will be responsible for diagnosing and repairing electric vehicles, working closely with service teams, and ensuring high quality and safety standards...SeniorRemote jobHourly pay- Creative Solutions Services, LLC is looking for a Quality Engineer to manage supplier quality by reviewing QNs and generating SQNs. The role includes collaborating with suppliers to resolve quality issues while driving part qualification through the APQP process. Candidates...SeniorWork at office
$78k - $130k
...configuration management policies. As a Senior Associate, your knowledge and... ...focus that will make Pfizer ready to achieve new milestones and... ...Participate in Regulatory inspections Ensure label requirements for... ...impact and distribution, and lead for quality operations...SeniorPermanent employmentLocal areaRelocation packageFlexible hours2 days per week$160k - $190k
Heads Up Technologies in Kirkland, Washington is seeking a Senior Embedded Software Engineer to enhance and manage embedded software for... ...experience, strong debugging skills, and the capacity to lead teams on critical projects. Competitive pay of $160,000 - $190,0...SeniorFull time$92.29k - $111.84k
Overview The Senior Specialist for the QA Sterility Assurance... ...including support for CAPA creation and Quality... ...partner departments. Lead meetings and represent... .... Support internal inspections as required. Perform other... .... Experience in FDA/EMA or similar regulation...SeniorHourly payFull timeTemporary workLocal areaRemote workFlexible hoursShift work- ...to enhance the quality assurance function within the organization. The role involves ensuring compliance with quality systems and leading QA support for outsourced cGMP operations. The ideal candidate should have at least 5 years of experience in the pharmaceutical industry...Senior
- ...Senior Tax Analyst – State Tax The Senior Tax Analyst supports U.S. tax operations with... ...state income tax compliance, reporting, audits, and planning. This role operates in a dynamic... ...practices to enhance scalability, audit readiness, and team effectiveness. Qualifications...SeniorLocal area
$56 per hour
...Job Title: Senior Welding Engineer Location: Bellevue... ...callouts Lead technical development of... ...to increase technology readiness levels of key materials... ...destructive and nondestructive inspection criteria for weld... ...Assist with supplier audits per ASME NQA-1-2015 Requirements...SeniorFull timeContract workFor contractorsLocal area- ...Accenture helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value... ...in FY25 revenue. Visit us at . As a Management Consulting Senior Manager within the Banking Consulting practice, you are a strategic...SeniorLive inWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior FDA CAPA & Audit Lead - Inspection Readiness. Be the first to apply!
- senior cloud service delivery manager Bothell, WA
- senior business analyst contract Bothell, WA
- senior software engineer Bothell, WA
- senior application security Bothell, WA
- senior database analyst Bothell, WA
- senior vice president of operations Bothell, WA
- senior ux designer remote Bothell, WA
- senior performance tester Bothell, WA
- senior sas developer Bothell, WA
- senior director diversity & inclusion Bothell, WA

