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 Title Senior CAPA FDA Lead 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...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- Job Title Senior Design Quality Engineer... ...transfer, as well as leading comprehensive... ...preparation for quality audits and inspections, maintaining all... ..., and executes CAPA processes,... ...ensuring ongoing audit readiness and strict... ...years’ experience in FDA regulated medical...Senior
- CyberCoders is looking for an experienced Audit Senior to lead and execute audit engagements for for-profit clients. This role involves planning, performing, and supervising audits according to professional standards, providing clear insights, and mentoring junior staff...Senior
$20 - $30 per hour
...Summary We are seeking a Manufacturing Support Technician I-Senior to perform routine manufacturing support activities, including... ...documentation, and work areas are prepared, maintained, and inspection‑ready. The Manufacturing Support Technician plays a hands‑on role on...SeniorContract work$140k - $185k
...partnering with them to identify an experienced Tax Manager who’s ready to lead engagements, mentor staff, and be a trusted advisor to clients... ...-held businesses Review returns prepared by staff and seniors for technical accuracy and compliance Research complex tax...SeniorWork at officeFlexible hours$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- ...Senior Automation Engineer – Global MSAT... ...requirements. Lead the continuous development... ...issues. Manage CAPAs and change... ...integration, and MES readiness for new processes.... .... Knowledge of FDA CFR 21 Part 11 compliance... ...in regulatory inspections or audit support....SeniorFlexible hours
$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
$80k - $200k
...Job Description Job Description Audit Associate through Audit Director – Public Accounting... ...000 – $200,000 base + bonus (DOE) Audit Senior / Audit Manager(Public Accounting)... ...Ability to oversee multiple engagements and lead client service efforts Audit Director...SeniorFor contractorsWork at officeFlexible hours- 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
$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$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$92.4k - $126.5k
...Material Quality Senior Specialist -... ...Process License Inspections (PLI) and transition... ...commercial readiness, we're building... ...., deviations, CAPAs) with... ...supplier onboarding audits, qualification,... ...patient safety. Lead in raw material... ...understanding of cGMP, FDA, and EMA...SeniorTemporary workWork at officeMonday to FridayFlexible hoursShift workDay shift$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$24.03 - $31.75 per hour
Verathon, Inc. is seeking a Quality Inspector III to join our QA/RA Team in Bothell, WA. The role involves performing inspections on incoming parts and final products, ensuring quality standards are met. The ideal candidate will have a High School Diploma with 2-4 years...SeniorFull time$24.52 - $36.79 per hour
Astronics- is hiring a Senior Quality Inspector in Kirkland, WA, to support a collaborative quality team. The role involves performing inspections using blueprints and established procedures, aiming to ensure product quality throughout production phases. Candidates need...SeniorHourly pay$70 per hour
...quality, care, and progress. If you're ready to grow your career, we're glad you found... ...be responsible for performing chiller inspections and maintenance. An ideal candidate will... ...operation of various mechanical systems. Lead role in defining and developing the training...SeniorHourly payFor subcontractorWork at officeNight shiftWeekend work$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$135k - $200k
...a Top National CPA Firm, is seeking a Tax Senior Manager to join their high-performing team... ...strategic tax planning and proactive solutions Lead and review tax engagements, ensuring... ...Opportunity Statement If you're ready to join a firm that truly values its people...SeniorSummer work$235.08k - $284.87k
...focus for this role is to lead the Quality Systems... ...Systems (Deviation, CAPA, Change Control, Complaints... ...ensuring site inspection readiness. The position leads the... ...party inspections and audits at the site and ensures... ...Regulations including FDA, EMA, and PMDA and rest...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inLocal areaRemote workFlexible hoursShift work$92.29k - $111.84k
...Position Summary: The Senior Specialist for the QA Sterility... ...including support for CAPA creation and Quality... ...departments. Lead meetings and represent... ...plan. Support internal inspections as required. Perform... ...operation. Experience in FDA/EMA or similar...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inLocal areaRemote workFlexible hoursShift work$85k - $90k
...Senior Facilities Technician Redmond, WA Our client, a commercial real estate company, is looking for a Senior Facilities Technician... ..., and scheduled maintenance services. Conduct roof inspections, repairs, and preventative maintenance. Maintain exterior lighting...SeniorFor contractors$25 - $30 per hour
..., records, and develop/update as needed. Conduct regular inspections and audits of the production process. Monitor and analyze customer complaints... ..., preferably in bakery. Good working knowledge of all FDA food manufacturing rules and regulations including FSMA/...For contractorsWork experience placementFlexible hoursNight shiftWeekend 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
$130k
Senior Project Manager - Water/Wastewater Infrastructure Kirkland, Washington | Direct Hire... ...a Senior Project Manager to support and lead municipal water and wastewater... ...client meetings, site visits, and field inspections Ensure projects are delivered on time and...SeniorLocal areaRelocation package$24.52 - $43.71 per hour
...Job Description Position Title: Senior / Specialist Quality Inspector Position Description: Protingent Staffing has an exciting... ...for precision verification and the troubleshooting of advanced inspection machinery. This role is ideal for a candidate with a...SeniorHourly payPermanent employmentWork at office$65 - $73 per hour
...Job Title: Senior Quality Assurance Engineer Location: Redmond,... ...involvement with quality systems, CAPA investigations, supplier... ...process improvement, testing and inspection to ensure that the products are... ...in and potentially lead the creation and/or review of...SeniorContract workFor contractorsLocal areaRemote work$104.63k - $161.9k
A leading medical device company in Bothell is seeking a Manager of Regulatory Compliance to oversee internal/external audits and compliance programs. This role requires a Bachelor's degree, a minimum of 3 years in a regulated environment, and strong leadership skills....
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 manager quality engineering Bothell, WA
- senior design technologist Bothell, WA
- senior director clinical development Bothell, WA
- senior director continuous improvement Bothell, WA
- senior performance engineer Bothell, WA
- senior manager diversity & inclusion Bothell, WA
- senior robotics software engineer Bothell, WA
- senior mainframe developer Bothell, WA
- senior cybersecurity engineer Bothell, WA
- senior manager m&a tax Bothell, WA



