Senior QA: Deviations, CAPA & Client Support Lead
KBI BioPharma
KBI Biopharma Inc. is seeking a Principal Quality Compliance Specialist in Durham, NC. This role involves reviewing and approving deviations and CAPAs to ensure GMP compliance, mentoring junior quality assurance staff, and collaborating with various departments to resolve compliance issues. Candidates should have a minimum of 14 years' experience in a QA cGMP regulated environment, with a comprehensive understanding of quality systems and regulatory guidelines. This position offers opportunities to contribute significantly to client audits and external reviews. #J-18808-Ljbffr
- ...Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations.... ...in EtQ and closure. Support external client review and resolution of comments for... ...deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and...Senior
- ...Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations.... ...in EtQ and closure. Support external client review and resolution of comments for... ...deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and...SeniorImmediate start
- ...individual for a role focused on the review and approval of Deviations and CAPAs to support GMP manufacturing operations. This position involves... ...resolve compliance issues and providing mentorship to junior QA staff. The ideal candidate will possess a scientific degree...Senior
- ...for review and approval of Deviations and CAPAs in support of GMP manufacturing operations... ...closure. Mentors junior QA staff in deviation/CAPA... ...deviations and assists in leading daily triage meetings. Provides... ...Deviations and CAPAs. Notifies the Client of deviations. Supports...Suggested
- ...recruiting for a Senior Manager, Quality... ...across a multi-client GMP environment.... ...operations. Supporting the growth of a... ...would be: Lead and develop a high... ...operational oversight of QA activities... ...including deviations, investigations, CAPAs, change controls...Senior
$113k - $156k
...data. The Principal QA Specialist... ...investigations, and laboratory deviations. The role ensures... ...compliance while supporting product lifecycle... ...of products to clients for patients. The... ...also serve as a team lead for specific... ...support for deviations, CAPAs, laboratory...- ...differential.Job SummaryThe QA Manufacturing... ...oversight for activities that support bulk drug substance... ...of cGMP operations. Client and regulatory audit/inspection... ...activities to resolve deviations, CAPAs, and other compliance... ...is required.MQA Senior Specialist: BS/BA...SeniorWork at officeImmediate startShift workNight shift
$110k - $140k
A leading research organization is seeking a Mid-Senior Quality Assurance Manager to support the development of new drugs through expert analysis of biological specimens. This role entails managing audits, authoring SOPs, and ensuring compliance with quality management...Senior- ...Quality-to-Quality client liaison and sometimes... ...team reporting cross-QA metrics and status... ...be responsible for supporting processes required for... ...release, including deviation investigation guidance and CAPA review and approvals... ...accountable Quality lead, decision maker, and...Immediate startFlexible hours
- ...requirements are met. Provide QA input into internal... ...GMP manufacture/packaging, support of on-the-floor manufacturing... ...manufacturing and packaging deviations and investigations. Lead continuous and quality improvement... ...of nonconformance and CAPAs related to the medical device...Senior
- ...Discovery Senior Living Holdings, LLC in Durham is hiring Care Givers to provide hands-on care and support to residents in a comfortable environment. Responsibilities include assisting with daily living activities, maintaining cleanliness, and engaging residents. The...Senior
- ...Creo Inc is looking for a Senior Analyst in IT Compliance and Quality based in North Carolina. The role focuses on managing IT compliance projects, delivering client-focused solutions, and enhancing regulatory compliance within the life sciences industry. Candidates should...Senior
$119k - $163.63k
...KBI BioPharma Inc. is looking for a Senior Program Manager in Durham, NC. This key team leader in the PMO will be responsible for the successful delivery of client portfolios and act as the primary relationship owner. The ideal candidate should possess a Bachelor's degree...Senior- A leading engineering firm is looking for a Lead Civil Engineer in North Carolina. The role involves managing small to medium project teams, performing civil engineering tasks, and fostering client relationships. Candidates should possess a Bachelor's degree in Civil Engineering...Senior
- BCG Attorney Search is seeking a Senior Trusts and Estates Attorney in Durham, NC. This role involves consulting with clients to analyze estates and prepare appropriate action plans, ensuring that legal documents align with client needs. The successful candidate will have...Senior
- KBI Biopharma in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. This role includes reviewing test data, supporting client audits, and providing QA oversight of laboratory activities. The ideal candidate...Senior
- A leading civil engineering firm in North Carolina is seeking a Project Manager to oversee project scope, schedule, and budget while ensuring quality coordination among stakeholders. Candidates should have over 8 years of relevant experience, a strong knowledge of AutoCAD...Senior
- Citrin Cooperman in Durham, NC is seeking an experienced tax professional to lead reviews of tax returns and manage client accounts. The ideal candidate will have a CPA, JD, or EA license along with a master’s degree in tax or LLM, and over 12 years of public accounting...Senior
- TELUS Digital is seeking a Senior Technical Product Lead to join their Product Delivery team. In this role, you will blend Agile product ownership with strategy, driving substantial impact for clients. You will foster relationships with stakeholders, manage complex backlogs...SeniorWork at office3 days per week
- A leading tax services provider in North Carolina is looking for a Tax Advisor to build year-round client relationships and provide comprehensive tax preparation and planning services... ...their financial goals year-round and support a diverse community dedicated to personal...Senior
- ...Operations, Innovation & Effectiveness Lead United Therapeutics (Nasdaq:... ...this role will provide operational support across Quality Records (e.g., deviations, Corrective and Preventive Actions,... ...Corrective and Preventive Actions [CAPAs], root cause analysis [RCA]) ~3+...SeniorWork at office3 days per week
$45.81k - $59.55k
Direct Support Coordinator Area: Community Assistance Reports to: Community Assistance Subdirector... ...ensuring balanced workloads and timely client attention. ● Monitor case flow from... ..., and culturally responsive. ● Identify deviations in service quality and propose immediate...Full timeWork at officeImmediate startAfternoon shift$65.25k - $169.4k
...partners. Job Responsibilities Lead and manage quality aspects... ...record review, disposition, deviation management, and change... ...improvement. Provide expert QA guidance and support during new product introductions... ...and preventive actions (CAPAs). Represent Eli Lilly's quality...Full timeH1bVisa sponsorshipWork visaFlexible hours$63k - $86.9k
...Senior QC Analyst (2nd Shift) – In-Process page is... ...with troubleshooting and support In-process Support... ...lab investigation and deviation reports* Supports implementation... ...projects or leading simple improvement projects... ...to serve our clients as they seek to advance...SeniorFull timeImmediate startMonday to FridayAfternoon shift- ...Senior Client Account Executive, Employee Health & Benefits Award-winning, inclusive, Top... ...with the global resources of the world's leading professional services firm, Marsh (NYSE... ...meetings to present renewal proposals and supporting documentation. They lead marketing...SeniorWork at officeLocal areaFlexible hoursNight shift
- ...JOB DESCRIPTION OVERVIEW CREO Senior Analysts in IT Compliance and... ...collaborating with senior staff to help clients navigate complex regulatory... ...into actionable insights, and support technology projects and... ...CA). POSITION RESPONSIBILITIES Lead and manage IT compliance and quality...SeniorWork experience placement
$65k - $90.82k
...to enable life sciences clients to improve lives. Our... ...Values: We empower and support our colleagues We... ...direction of the Validation Lead and alongside the CQV... ...Document any deviations discovered during CSV testing... ...assessment, and track CAPAs to closure. Required...SeniorFull timeTemporary workWork experience placementLocal area- ...FUJIFILM Biotechnologies is looking for a Senior Software Test Engineer in Durham, NC, to manage testing responsibilities for the Synapse Enterprise Information System (EIS). This role includes enhancing software reliability through manual testing practices and automation...Senior
- KBI Biopharma in Durham, North Carolina is seeking a qualified candidate for a position responsible for the compliance review of biopharmaceutical development GMP data. This includes overseeing release, in-process, and stability test data, method qualifications, and laboratory...Senior
- ...investigations. The ideal candidate has a BS with 11+ years or MS with 8+ years in a regulated environment, along with substantial experience in QA data review, knowledge of USP, EU, and JP cGMP guidelines, and excellent analytical skills. #J-18808-Ljbffr KBI Biopharma, Inc.Senior
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