Senior QA Specialist: GMP, Regulatory Inspections & CAPA Lead
Hartmann Young
Hartmann Young in New York partners with a global CDMO to expand their QA team. The Senior QA Specialist will review documents, protocols, qualifications and reports within the Quality Management System and may participate in regulatory inspections and client audits. You'll collaborate across functions, drive CAPAs, support inspection readiness, review master batch records, and report quality metrics to leadership. #J-18808-Ljbffr Hartmann Young
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior QA Specialist: GMP, Regulatory Inspections & CAPA Lead in New York, NY vacancy
- ...Job Title: Senior QA Specialist Location: New York, NY... ...within a highly regulated GMP environment. The ideal... ...systems, investigations, CAPA, change control, risk management, and regulatory compliance. Key... ...audits, regulatory inspections, and inspection-readiness...SeniorRegulatory
Intellectt INC
New York, NY1 day ago - ...We are seeking a senior QA specialist who will play a critical... ...findings, deviations, and CAPAs (Corrective and... ...based audit planning and inspection readiness assessments... ...in accordance with regulatory timelines 3. Training... ...sign‑off for deviations Lead or assist in pre‑...SeniorRegulatoryWork at officeRemote work
EDETEK
New York, NY4 days ago - ...Job Title: Senior Quality Assurance Specialist Location: New York... ...Senior Pharma QA Specialist to support... ...regulated GMP environment.... ...investigations, CAPAs, change controls... ...and applicable regulatory requirements.... ...regulatory audits and inspection readiness....SeniorRegulatoryContract work
Intellectt INC
New York, NY1 day ago - ...New York. Summary: The Senior Quality Assurance (QA) Specialist is responsible for the... ...to participate in regulatory inspections, client audits and internal... ...Management, and CAPAs. Work cross-functionally... ...completion of assigned tasks. Lead and drive the GMP activities, work with...SeniorRegulatoryContract work
- United Pharma is seeking experienced QC Specialists to support a GMP pharmaceutical site undergoing FDA... ...compliance, data integrity, and inspection readiness. Responsibilities include... ...investigations as needed to withstand regulatory scrutiny. #J-18808-Ljbffr United PharmaRegulatory
- ...York seeks an experienced Senior Validation Engineer to lead equipment, process,... ...validation programs in a GMP environment. You will develop... ...assessments, and support regulatory inspections while mentoring junior staff... ...collaboration with QA, Engineering, Regulatory...SeniorRegulatory
$72k
...invoices. The role assists QA product managers with... ...Acrotech SOPs. The Specialist will also help ensure... .... Review deviations, CAPA, complaint... .... Support client and regulatory audits and inspections as scribe and process... ...years of experience in a GMP environment such as a...RegulatoryTemporary workFor contractorsWork at officeFlexible hoursAcrotech Biopharma inc.
New York, NY3 days ago- Leading sponsor-side QA oversight of CMOs, the full-time Senior Manager, GMP Quality will manage quality activities across pre-clinical... ...and test data, and support regulatory submission quality reviews... ...products Preferred experience with inspection readiness, both domestically...SeniorRegulatoryFull timeContract workRemote work
$40 - $45 per hour
A well-known biopharmaceutical company is seeking a remote QA Specialist for a short-term contract. This role involves leading deviation investigations and writing CAPAs, requiring 4 to 7 years of GMP quality assurance experience. Candidates should have hands-on experience...Remote jobHourly payTemporary work- ...with cross-functional teams, manage critical QA deliverables, and ensure alignment with regulatory requirements to enable timely launches. The... ...analytical and communication skills, expertise in CAPA and RCA, and experience with GMP/validation processes. #J-18808-Ljbffr PCI...Regulatory
- ...seeking an experienced Senior Validation... ...validation activities in a GMP-regulated... ...ideal candidate will lead equipment, process... ...cGMP, and global regulatory requirements. This... ...deviations, implement CAPAs, and support... ...audits, regulatory inspections, and client audits...SeniorRegulatory
Novozen Healthcare LLC
New York, NY3 days ago $104.29k - $141.09k
...transforming your career. Specialist Quality... ...quality inspection and sampling, environmental... ...Practices (GMP), Good... ...addressing deviations, CAPAs, change... ...interacting with regulatory agencies Support... ...chain management Lead initiatives, programs... ...overseeing QA in distribution...RegulatoryFlexible hoursAmgen
New York, NY2 days ago- BeiGene, Ltd. is seeking an AD, Regulatory Affairs CMC dedicated to developing and implementing global regulatory strategies for market access... ...of experience in regulatory affairs, with strong knowledge of GMP regulations, and excellent communication and project management...SeniorRegulatory
- ...Holdings, Inc. is seeking a Quality Manager to lead the site Quality function for Healthcare... ...will drive QMS compliance, partner with Regulatory, Operations, and external customers, and... ...and FDA knowledge, plus experience with inspections and audits. #J-18808-Ljbffr Mativ...SeniorRegulatory
$147k - $167k
Senior Manager, Analytical Sciences - Commercial... ...health authority inspections. The Opportunity... ...as the analytical lead for Praxis’... ...in compliance with regulatory commitments and supporting... ..., complaints, and CAPAs, driving root... ...consistent with FDA and EU GMP expectations....SeniorRegulatoryWork at officeLocal areaRemote work- Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance... ...with global regulatory expectations... ...shaping risk-based PV QA systems, and... ...tracking. Maintains inspection readiness... ...ensure effective CAPA management, deviation... ...alignment with GMP, GDP, and PV...SeniorRegulatory
$62.36k - $128.7k
...seeking to fill a QA Microbiology Specialist position within... ..., supports regulatory and compliance activities... ...submissions, inspections, and responses... ...preventive actions (CAPAs). Support... ...Specialist - 2+ years Senior Specialist - 5+... ...Regeneron is a leading biotechnology...RegulatoryWork experience placementMonday to Friday$115k - $120k
ABOUT GREYSTARGreystar is a leading, fully integrated global real estate platform offering... ...assets and over $30 billion of regulatory assets under management. Greystar was founded... ...leases, conducts periodic apartment inspections, follows proper notice requirements, evictsresidents...SeniorRegulatoryFull timeFor contractorsWork at officeLocal areaImmediate startFlexible hoursWeekend workAfternoon shift$136.5k - $181.5k
...Description: The Senior Manager, GxP Computerized... ..., Clinical, Regulatory, and third-party service... ...gaps, support inspection readiness, and... ...metrics. Plan and lead internal, supplier... ...GxP regulations, EU GMP Annex 11 and Annex... ...audit responses, and CAPA evaluation. Strong...SeniorRegulatoryHourly payContract workLocal areaWorldwide- CQ Medical is seeking a Quality Systems Specialist II to independently drive complaint investigations, CAPA activities, and risk assessments across cross‑functional... ...junior personnel while partnering with Engineering, Manufacturing, Regulatory #J-18808-Ljbffr CQ MedicalRegulatory
- ...overlooked. Our lead program, QTORIN... ...and BIMO inspections that come with... ...lead role for a senior quality professional... ...closely with the VP, QA & QC, leading... ...— including GMP/CMC and... ...timely, effective CAPA. Partner with... ...Operations, and Regulatory Affairs to embed...SeniorRegulatory
- ...strategic and hands-on Senior Manager,... ...implement, and lead a robust,... ...Quality Assurance (QA) and Quality Control... ...meet regulatory requirements, internal... ...routine GMP audits (domestic... ...investigation, and CAPA systems. Conduct... ...regulatory inspections. Excellent analytical...SeniorRegulatoryContract work
- Jobtailor is seeking a senior quality/regulatory leader in New Jersey to drive product escalation processes... ...directives. The role requires strong GMP/quality culture and an ability to... ...for audits, support health authority inspections, and drive process improvements across...SeniorRegulatory
- ..., Georgia, seeks a Quality Control Manager to lead all QC activities, oversee microbiological and... ...risk mitigation, continuous improvement, and regulatory compliance. The candidate will lead a matrix team, ensure inspection readiness, manage budgets, and advance quality...RegulatoryContract work
$127.4k - $172.4k
## Job Title: Senior Manager QC Microbiology, (Hopewell... ...equipment. Supports regulatory compliance inspections. Ensures efficient... ...of the job:*** Lead the Environmental Monitoring... ...Deviations, CAPAs and Change Controls.*... ...activities to support GMP manufacturing and microbiological...SeniorRegulatoryHourly pay- ...is seeking a GCP Quality Assurance Specialist to support a leading clinical research organization. This... ...maintaining the QMS, administering QA training and CAPA programs, conducting GCP audits, and supporting regulatory inspections. 3-5+ years QA experience and a Bachelor...RegulatoryRemote job
- ...across the facility. The Senior Director drives... ...Ensuring compliance to OSHA & GMP/SQF standards.... ...Receiving of goods – Planning, inspection, receipt and reverse receiving... ..., State and Federal regulatory compliance Maintain... ...opportunities for improvement. Lead and/or partner with...SeniorRegulatoryLocal area
Baldor Specialty Food
New York, NY3 days ago - Electricmind is seeking a Senior Consultant in New York to advise U.S. banks on critical cybersecurity compliance issues. Applicants will lead client engagements, ensuring regulatory needs are met through effective remediation plans and technical execution. The ideal candidate...SeniorRegulatory
$211.28k - $316.92k
...0 - $316,920.00Category: Legal, ProfessionalCompany: CitiThe Senior Lead Counsel is a position responsible for serving as strategic business... ..., widely accepted business practices, laws, rules, and regulatory guidelines, escalating where appropriateCollaborates across internal...SeniorRegulatoryFull time- ...contract development and manufacturing organization to recruit a QA Specialist II in New York. This role provides on-the-floor QA... ...personnel performance, author and approve QMS documents, and participate in audits and regulatory inspections. #J-18808-Ljbffr Hartmann YoungRegulatoryContract work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior QA Specialist: GMP, Regulatory Inspections & CAPA Lead. Be the first to apply!
Related searches
- quality assurance associate New York, NY
- qa specialist New York, NY
- qa associate New York, NY
- senior quality assurance specialist New York, NY
- software quality assurance specialist New York, NY
- quality assurance specialist New York, NY
- senior maintenance supervisor New York, NY
- senior lead project manager New York, NY
- senior robotics software engineer New York, NY
- senior firewall engineer New York, NY