GMP Senior Auditor
Katalyst Healthcares and Life Sciences
Job Description:
- Must Have Radiopharmaceuticals and Quality experience.
- ll others will not be considered. *** The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards.
- This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes.
- Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers.
- Prepare detailed audit plans, checklists, and schedules.
- Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines.
- Review and approve deviations, CAPAs, and change controls.
- Document audit observations and issue formal audit reports.
- Track and verify implementation of corrective and preventive actions (CAPAs).
- Provide guidance on compliance requirements and audit readiness.
- Support regulatory inspections and customer audits.
- Identify systemic issues and recommend process improvements.
- Stay updated on evolving regulatory requirements and industry best practices.
- Bachelor's degree in Life Sciences, Pharmacy, or related field.
- 3-5 years in Radio Pharmaceuticals, with at least 2 years in auditing.
- Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.
- Excellent attention to detail and analytical skills.
- Strong communication and report-writing abilities.
- bility to travel (up to 10%) for audits. Preferred Certifications.
- SQ Certified Quality Auditor (CQA).
- ISO 9001 Lead Auditor.
- GCP/GMP auditing certifications.
Vacancy posted 10 hours ago
Similar jobs that could be interesting for youBased on the GMP Senior Auditor in Paramus, NJ vacancy
- ...Radiopharmaceuticals Quality Assurance Auditor The Radiopharmaceuticals Quality Assurance Auditor is responsible for planning, conducting... ...Certifications: ~ ASQ Certified Quality Auditor (CQA). ~ ISO 9001 Lead Auditor. ~ GCP/GMP auditing certifications....Senior
Katalyst HealthCares & Life Sciences
Paramus, NJ9 hours ago - ...GMP Sr. Auditor Paramus, NJ GMP Sr. Auditor Paramus, NJ Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation...SeniorHourly payVisa sponsorshipRelocation package
ESR Healthcare
Paramus, NJ4 days ago - Industry: Biopharma - Neurology & Psychiatry Therapies Job Summary: This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure ...Senior3 days per week
Macpower Digital Assets Edge
Paramus, NJ11 hours ago - ...Job Description GCP Senior Auditor Paramus, NJ (Hybrid) Contract Mid-Senior Level Ensure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies. A rapidly growing...SeniorContract work
Together We Talent
Paramus, NJ5 days ago - ...About the job Sr. Auditor Sr. Auditor Quality Assurance (Pharmaceuticals) Location... ...contract Experience Level: Mid-Senior Experience Required: 5+ Years... ...external audits to ensure compliance with GMP, GDP , and other global regulatory standards...SeniorHourly payContract workRelocation package
Global Placement Firm
Paramus, NJ11 hours ago - ...GCP Sr. Auditor Paramus, New Jersey, United States About the Job GCP Sr. Auditor The GCP Quality Assurance Sr. Auditor will report to the Director of GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities...Senior
5 Star Global Recruitment Partners
Paramus, NJ4 days ago - ...Sr. Internal Auditor Pay Range: $96,000 - $120,000 / year Hybrid 3x a week on-site in Secaucus Salary offers are based on a wide... ...accounting and/or auditing, with at least one year in a lead or senior audit capacity ~ A diverse background combining Public...SeniorFull timePart timeWork at officeFlexible hours
Staff Icons
Secaucus, NJ3 days ago - ...Responsibilities Kforce's client, a publicly traded healthcare company in Rutherford, NJ, is seeking a Senior Internal Auditor. The role is hybrid and will be 3 days in the office and 2 days remote and commutable by mass transit from NYC. Internal Auditors at this...SeniorHourly payContract workWork at officeRemote workFlexible hours
Kforce
Rutherford, NJ4 days ago - ...Responsibilities Kforce's client, a publicly traded healthcare company in Rutherford, NJ, is seeking a Senior Internal Auditor. The role is hybrid and will be 3 days in the office and 2 days remote and commutable by mass transit from NYC.Summary:Internal Auditors...SeniorHourly payContract workWork at officeRemote workFlexible hours
Kforce
Rutherford, NJ2 days ago - ...This hybrid role will require associates to be onsite 4 days a week in our Franklin Lakes, NJ corporate headquarters. As Senior Internal Auditor, you will be responsible for evaluating the adequacy of the Company's system of internal controls to ensure the protection...SeniorDaily paidTemporary workWork at officeRemote workWorldwideFlexible hours
Becton Dickinson
Franklin Lakes, NJ9 hours ago - ...Senior Manager in Statistics The Senior Manager in Statistics is responsible for performing statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings, and marketing....Senior
Katalyst HealthCares & Life Sciences
Paramus, NJ1 day ago - Roles & Responsibilities: ~ Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. ~ Plan and conduct audits of specific clinical processes based on risk. ~ Perform clinical vendor audits along with various SMEs (...
Katalyst Healthcares and Life Sciences
Paramus, NJ5 days ago - ...process improvements across the finance systems ecosystem. Responsibilities Finance Systems Support & Ownership Provide senior-level support and administration for SAP BPC, including planning, forecasting, reporting, data loads, and model enhancements....SeniorFor contractorsWork at office
Konica Minolta Business Solutions Ltd
Ramsey, NJ3 days ago - Senior Director, Clinical Development - Oncology - SK Life Science Labs Job LocationsUS ID2026-1934 CategoryMedical Affairs TypeRegular... ...Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development...SeniorFull time
SK Life Science, Inc.
Paramus, NJ11 hours ago - ...Job Title – Lead Auditor Location - Franklin Lakes, NJ Duration – 4+ Months Work hours: 8am-5pm, 40 hours/week Client: Medical... ...relevant standards, specifically ISO 13485, ISO 14971 and/or GMP regulatory requirements related to the medical device. • Assist...Full timeContract workWork experience placementWork from home
MILLENNIUMSOFT
Franklin Lakes, NJ4 days ago $33.99 - $42.49 per hour
...Outpatient Coding Auditor The Outpatient Coding Auditor is responsible for auditing coded outpatient medical records to ensure compliance with official coding guidelines, regulatory agencies, and internal policies. This role supports coding accuracy, education, and...Remote jobHourly payFull timeTemporary workPart timeLocal areaFlexible hoursShift work$150k - $200k
...Senior Audit Manager (With Tax Exposure) Savastano Kaufman & Co., is hiring! Savastano Kaufman & Co. is an independent, full-service accounting and advisory firm specializing in accounting and consulting services for businesses and individuals. We currently have an...SeniorTemporary work- Must Have: Ph.D or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package Excellent knowledge of industry standards, such as the ICH guidelines...Senior
VBeyond
Paramus, NJ2 days ago $93 per hour
...Summary of Position: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Duties...SeniorPeople, Data & Solutions
Paramus, NJ2 days ago$95k - $105k
Longbridge Financial is seeking an experienced Underwriter in Paramus, New Jersey. This role entails evaluating residential loans to ensure compliance with regulations. Candidates should have three or more years of experience underwriting Reverse Mortgages and possess ...SeniorLongbridge Financial, LLC
Paramus, NJ4 days ago- Must Have: ~3+ years of experience in recruitment, HR coordination, talent acquisition, or HR operations ~ Full-cycle recruitment support experience - including resume review, candidate screening, interview coordination, and offer/onboarding assistance ...SeniorWork at office
VBeyond
Paramus, NJ2 days ago - ...Senior System Admin A leading provider of IT Managed Services in New York City/ Northern New Jersey is looking for a Systems Admin to provide service to its clients in the NYC metro area. This is a great opportunity for a self-starter with a proven track record to...SeniorFull timeWork at office
Aequor Inc
Rochelle Park, NJ2 days ago $89.6k - $149.3k
...Communicate audit progress and findings to Bank management and oversee Auditors (as applicable) on assigned audit activities. Primary... ...auditing standards. The jobholder reports to an Audit (Senior) Manager. Supervisory/Managerial Responsibilities: Education...Work experience placementRemote workRelocationM&T Bank
Passaic, NJ5 days ago$30 per hour
...Professional Coding Auditor FT Days Req Id: 64915 Englewood Health, a leading healthcare system comprising Englewood Hospital and the Englewood Health Physician Network, is committed to delivering exceptional patient care across northern New Jersey. We...Full timeWork at officeShift workEnglewood Health
Englewood, NJ3 days ago$46.99k - $122.4k
...helping to simplify health care one person, one family and one community at a time. Position Summary The Program Integrity Auditor is responsible for the review of records for medical, behavioral, transportation, and other healthcare providers. The Auditor must...Hourly payFull timeTemporary workLocal areaMonday to FridayFlexible hoursCVS Health
Rutherford, NJ4 days ago- ...Job Description: The GCP Quality Assurance Auditor reports to the Director of GCP/PVG Quality Assurance and is responsible for ensuring GxP compliance with regulatory authorities. The role focuses on implementing compliance directives, supporting quality management...
Katalyst Healthcares and Life Sciences
Hackensack, NJ3 days ago - ...premises. All team members will require certain occupational health requirements to include inoculations and periodic testing. Auditors will work in warehouses, storerooms, clean rooms, and sterile environments where waring hospitals provide scrubs, and related protective...
ADEX
Ramsey, NJ4 days ago $63k - $87k
...Compliance Medical Records Auditor Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are Leading Radiology Forward. With dynamic cross-training and advancement opportunities in a team-focused environment, the...Immediate startRadNet
Passaic, NJ7 hours ago- Description : Bring your knowledge of multi-line claims to a growing team of an established retail insurance agency!!! Responsible for handling commercial P&C as well as marine claims from first notification to final claim settlement. Deal with correspondence and file...SeniorWorldwide
C. Winchell Agency, Inc.
Paramus, NJ4 days ago $1,000 per month
Join Our Team as a Website Tester at Little Wheel Little Wheel is a gambling technology company focused on researching and building products that put players first. We are currently hiring Website Testers across Michigan, New Jersey, Pennsylvania, and West Virginia...Extra incomeTemporary workSecond jobCurrently hiringImmediate startWork from homeFlexible hoursLittle Wheel
Little Falls, NJ5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to GMP Senior Auditor. Be the first to apply!
Related searches
- medical claims auditor Paramus, NJ
- remote nurse auditor Paramus, NJ
- senior performance engineer Paramus, NJ
- senior property accountant Paramus, NJ
- senior leadership Paramus, NJ
- international tax senior Paramus, NJ
- senior financial analyst remote Paramus, NJ
- senior customer service Paramus, NJ
- senior sales Paramus, NJ
- senior vice president of operations Paramus, NJ