Senior QA Lead - GLP/QMS, CAPA & Compliance
$110k - $140kOpAns LLC
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 systems. The ideal candidate should possess strong communication and organizational skills and have a background in regulatory environments. The position offers a competitive salary ranging from $110,000 to $140,000 annually. #J-18808-Ljbffr
- KBI Biopharma Inc. in Durham, NC is seeking a Senior QA Specialist to oversee the review and approval of deviations and CAPAs supporting GMP manufacturing operations. The... ...and will mentor junior QA staff, ensuring compliance with regulatory requirements. KBI offers a collaborative...Senior
- AskBio Inc. in Durham, North Carolina is seeking a Senior Specialist in Quality Assurance. The role involves overseeing the Vendor Qualification Program, ensuring compliance with regulations, and performing vendor assessments. Ideal candidates should possess a Bachelor...Senior
$113k - $156k
KBI Biopharma, Inc. in Durham, North Carolina seeks a Principal QA Specialist to oversee compliance review of GMP data. This role includes reviewing in-process, release, and stability test data, providing QA support for laboratory activities, and ensuring regulatory compliance...Senior- ...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... ...have a minimum of 14 years' experience in a QA cGMP regulated environment, with a...Senior
- ...focused on the review and approval of Deviations and CAPAs to support GMP manufacturing operations. This... ...involves collaborating with various departments to resolve compliance issues and providing mentorship to junior QA staff. The ideal candidate will possess a scientific...Senior
- IQVIA LLC is seeking a Sr. QA Auditor in Durham, North Carolina. Responsibilities include planning and conducting independent audits to ensure compliance with regulations. You will prepare and distribute audit reports, consult on regulatory matters, and manage quality...Senior
- Alcami Corporation in Morrisville is seeking a Senior Quality Assurance Specialist. This role is responsible for ensuring quality and compliance with regulatory requirements and will include activities such as performing internal audits, maintaining quality databases, and...SeniorFull timeAfternoon shift
- ## Senior GPS & PV, Quality Control, Compliance & Training ManagerApplyremote type: Hybridlocations... ...control.This role will lead the design, development, and... ...Management System (QMS).Training Operations, Innovation... ...Corrective and Preventive Actions (CAPAs), audit findings, process...SeniorWork at office3 days per week
- Initial Therapeutics, Inc. is seeking a Lead QA Floor Lead Tech to ensure safe drug product quality in Durham, North Carolina. This... ...operations, monitoring quality systems, and overseeing documentation compliance. The ideal candidate will have a minimum of a High School/GED...
- A consulting service provider is seeking a Technical Test Lead for Automation Testing in Durham, NC. The role requires at least 4 years of IT experience with a focus on automation tools like Selenium and Cucumber. Candidate must possess strong analytical and leadership...SeniorFull timeRelocation package
$65.25k - $169.4k
...pharmaceutical leader seeks a Quality Assurance professional to oversee API external manufacturing operations. This role involves ensuring compliance with cGMP and regulatory requirements throughout the manufacturing process. The ideal candidate will have a strong background in...Senior- Senior Manager, Quality Systems and Compliance Location: Durham, NC, US Company: oxfordbiom We’re currently recruiting... ...difference. Responsibilities Lead and oversee site Quality Systems to... ...execution of deviation management, CAPA, change control, quality metrics, Quality...Senior
- ...joining our team? Job Summary The Senior Manager, Quality Operations is... ...corrective action activities (CAPAs), and quality audits and... ...0pm. Responsibilities Ensures compliance with regulatory requirements and... ...s Quality Management Systems (QMS). Collaborates with site Operations...SeniorMonday to FridayDay shift
$120.5k - $276.5k
Hobbsnews is seeking a Senior Quality Assurance Engineer to lead project teams and ensure quality in software testing. This role offers a hybrid work model requiring in-office presence 2 days a week. Candidates should have a strong background in software systems and a Bachelor...SeniorWork at office2 days per week- ...opportunities to join us. We’re currently recruiting for a Senior QA Specialist, Compliance and Supplier Quality to join our team. In this role, you... ...supplier audits (remote and on‑site), including audit reporting, CAPA assessment, and follow‑up. Maintain oversight of critical...SeniorRemote work
- ...with the Managers and Senior Managers Quality... ...Management, Clinical Team leads and with other... ...with MRL QA and acting as the link... ...commitment to regulatory compliance. Ensures that a... ...findings, responses and CAPAs, worldwide. Acts as... ...regarding the QMS, RACT, Quality Plans...Full timeContract workWork at officeWorldwide
- ...for review and approval of Deviations and CAPAs in support of GMP manufacturing... ...deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and approval... ...production related deviations and other compliance issues in a timely manner. Review and approve...Senior
- Senior QA Specialist Deviations and CAPAs page is loaded## Senior QA Specialist Deviations and CAPAslocations: USA - NC - Durham - Hamlin Rdtime type:... ...activities to resolve production related deviations and other compliance issues in a timely manner. Review and approve...SeniorImmediate start
$110k - $140k
...corrective and preventive actions (CAPAs) Authoring / reviewing... ...’ quality management system (QMS) documents (e.g., SOPs, templates... ...and policies) assuring compliance with the applicable regulations... ...Perform other duties as assigned. Seniority level Mid‑Senior level...Full timeContract work$59.83k - $99.96k
...dedicated Operations Manager in Durham, NC. This role focuses on independent oversight and training of study teams, ensuring participant compliance and data integrity. Candidates will manage recruitment initiatives and work closely with clinical teams to enhance participant...Senior- ...pharmaceutical company in North Carolina seeks a QC Chemist III to ensure compliance in the testing and documentation of raw materials. This role... ...and have experience in a GMP environment. This is a full-time position offering senior level responsibilities. #J-18808-Ljbffr...SeniorFull time
$35.87 - $51.57 per hour
UNC REX Healthcare is seeking a Clinical Quality Assurance Specialist to lead efforts in ensuring compliance with regulations and improve patient safety. This role involves monitoring quality standards, collaborating with teams, and ensuring accreditation readiness, with...Remote jobHourly pay- ...their own expense. Job Duties and Responsibilities will include but are not limited to the following: Serve as the Program QA Lead for multiple large-scale, enterprise-wide initiatives within the client's organization. Develop and implement comprehensive QA strategies...Local areaRelocation1 day per week
- Wolfspeed in Durham, North Carolina is seeking a Senior Tax Analyst to support Federal and State compliance and tax accounting under ASC 740. The ideal candidate has a minimum of 3 years in Public Accounting with Corporate income tax exposure and CPA certification. This...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
- ...A leading pharmaceutical company in North Carolina seeks a Production Director. This role involves providing leadership and direction to cGMP manufacturing, ensuring compliance, operational efficiency, and the successful delivery of client projects. The ideal candidate...Senior
- ...Government Jobs - Other Agencies is seeking a Supervisory Auditor in Durham, North Carolina. This role involves leading complex audits, ensuring compliance with GAGAS, and providing technical leadership to an audit team. The ideal candidate will have strong communication...Senior
$75.4k - $188.6k
Sr. QA Auditor - 41779 page is loaded## Sr. QA Auditor... ...audits to assess compliance with regulations, guidelines... ...Corrective Action Prevention (CAPA) and Effectiveness Check... ...• May perform GLP Archivist duties where needed... ...the audit lifecycle • Lead/collaborate/support in QA...SeniorFull timePart timeImmediate startWorldwide- A leading organization in technology and cybersecurity is seeking a Senior Cyber Security Engineer in North Carolina. You will enhance security architectures, evaluate controls, and collaborate on compliance initiatives. The ideal candidate will have strong technical fluency...Senior
$190k - $260k
Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years... ...candidate will manage regulatory submissions and ensure compliance with global regulations while fostering collaboration across teams...Senior
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