Trabajos internal auditor en Yonkers, New YorkCrear alertas

Job Description Sr. Auditor Quality Assurance (Pharmaceuticals) Location: Paramus, NJ (100% On-Site) - 5 month contract Experience Level: Mid-Senior Experience Required: 5+ Years Education Required: Bachelors Degree (Life Sciences or related field) Industry: Pharmaceuticals / Life Sciences Job Function: Quality Assurance / Auditing / Compliance Compensation: Hourly Competitive (rate provided upon request) ️ Relocation Assistance: Not Provided Visa Sponsorship: Not Available Position Summary We are seeking a Senior Quality Assurance Auditor with strong experience in the pharmaceutical or radiopharmaceutical sector. This role is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with GMP, GDP, and other global regulatory standards. The successful candidate will play a critical role in upholding our Pharmaceutical Quality System (PQS) and ensuring inspection readiness across operations. Key Responsibilities Conduct internal audits, supplier audits, and contract manufacturer (CMO) audits including routine, for-cause, and risk-based. Develop and manage audit plans, schedules, and checklists based on regulatory guidelines and internal SOPs. Assess compliance with FDA, EMA, ICH, and international GMP/GDP regulations. Review and evaluate deviations, CAPAs, and change control records. Generate detailed audit reports and communicate findings to internal and external stakeholders. Track CAPA implementation and verify effectiveness through follow-up assessments. Support regulatory authority inspections and third-party audits. Provide expertise on quality and compliance-related matters, promoting audit readiness culture. Identify systemic gaps, recommend improvements, and drive continuous quality improvement initiatives. Stay current on regulatory changes, industry trends, and quality system best practices. Required Qualifications Bachelors degree in Life Sciences, Pharmacy, or a closely related field 5+ years of pharmaceutical QA experience (with at least 2 years conducting audits) Proven understanding of GMP, GDP, and radiopharmaceutical (RPT) compliance Familiarity with global regulations including FDA, EMA, ICH Excellent documentation, communication, and analytical skills Ability to travel up to 10% for audits (domestic and potentially international) Preferred Certifications ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor Certification GCP/GMP Auditing Certifications Why You Should Apply If you're looking to leverage your audit and compliance skills in a growing, highly specialized sector like radiopharmaceuticals, this role offers the ideal opportunity. You'll work in a critical QA function with visibility across manufacturing, testing, and supply chain operations, helping to uphold product integrity and patient safety. This is a high-impact position where your attention to detail and regulatory expertise will directly contribute to maintaining compliance, improving systems, and supporting global quality standards. Whether you're looking to step into a senior auditing role or expand your influence across a broader QA landscape, this opportunity provides the structure, challenge, and responsibility to help elevate your career. Apply now to join a team committed to excellence in pharmaceutical quality and make a difference in the future of healthcare.

Job Description The Incoming Inspection Manager leads the Incoming Inspection function and ensures purchased components, materials, assemblies, and supplier-provided products meet engineering drawings, specifications, purchase order requirements, supplier certifications, company standards, and applicable quality system requirements. This hands-on technical management role directs inspection activities, develops inspection personnel, improves throughput and capability, and serves as a technical resource for complex dimensional inspection, including CMM, vision measurement systems, portable coordinate measuring equipment, GD&T, and First Article Inspection (FAI). Essential Duties and Responsibilities • Manage daily Incoming Inspection activities, including workload, priorities, staffing assignments, backlog, throughput, and resource allocation to support business and production requirements., • Lead and develop Incoming Inspection personnel while establishing clear expectations for quality, productivity, documentation, responsiveness, safety, and adherence to Quality procedures., • Perform and oversee complex visual, dimensional, mechanical, and documentation-based inspections of incoming materials and products to verify conformance with engineering drawings, specifications, purchase orders, bills of material, inspection plans, and applicable Quality requirements., • Program, operate, and provide technical leadership for CMMs, vision measurement systems, portable coordinate measuring systems, including FARO or comparable articulated measurement arms, and other precision metrology equipment., • Lead First Article Inspection activities and develop and improve inspection plans, programs, work instructions, checklists, and inspection methods to increase consistency, capability, and efficiency., • Ensure supplier certifications, test reports, inspection records, traceability documentation, lot/serial records, and other controlled Quality records are reviewed, completed, and maintained accurately., • Oversee identification and control of nonconforming material and support material review, containment, return-to-vendor activities, root cause investigations, supplier corrective actions, and recurring defect resolution., • Partner with Quality, Engineering, Purchasing, Warehouse, Production, Inventory, and Supplier Quality to resolve incoming material issues and improve inspection and supplier performance., • Ensure inspection and measurement equipment is properly maintained, available, and within calibration requirements., • Support internal, supplier, customer, and third-party audits by ensuring required inspection records, traceability, and objective Quality evidence are available., • Maintain a safe, organized, and effective Incoming Inspection environment and perform other duties as assigned. Supervisory Responsibilities This position has direct supervisory responsibility for the Incoming Inspection function, including the Incoming Inspector Supervisor/Lead and Incoming Inspectors. • Assign and prioritize work, monitor completion, and ensure adequate coverage for business requirements., • Set performance, quality, productivity, and development expectations and provide coaching, feedback, technical mentoring, and performance management., • Support hiring, onboarding, cross-training, succession planning, and continued development of inspection capability., • Balance people leadership with hands-on technical involvement and support complex inspection activities when required. Education/Experience Required • Bachelor’s degree in Quality, Engineering, Engineering Technology, Manufacturing, Metrology, or a related discipline highly preferred. Equivalent directly related experience may be accepted in lieu of a degree., • Minimum of 5-7 years of progressive experience in incoming inspection, dimensional inspection, manufacturing quality, supplier quality, precision manufacturing, or a closely related Quality discipline., • Prior supervisory, management, or demonstrated technical leadership experience required, including experience training, mentoring, and developing inspection personnel., • Hands-on experience programming and operating CMMs, vision measurement systems, FARO or comparable articulated measurement arms, and other advanced dimensional inspection equipment strongly preferred., • Demonstrated experience interpreting complex engineering drawings, specifications, tolerances, GD&T, and inspection plans and supporting First Article Inspection activities., • Experience with supplier Quality documentation, traceability, nonconforming material control, corrective actions, and audit support., • Experience within precision machining, industrial equipment, mechanical or electromechanical manufacturing, or a comparable environment preferred., • Working knowledge of ISO 9001:2015 required; familiarity with ISO/IEC 17025:2017 preferred., • Experience using ERP and/or Quality Management Systems for inspection, traceability, inventory, and Quality documentation preferred. Preferred Certifications • ASQ Certified Quality Inspector (CQI), Certified Quality Technician (CQT), or Certified Manager of Quality/Organizational Excellence (CMQ/OE)., • GD&T training or certification., • CMM programming, metrology, or dimensional inspection training/certification., • Internal Auditor training. Required Skills/Abilities Necessary: • Strong technical judgment and problem-solving ability within a precision inspection and manufacturing environment., • Demonstrated ability to lead employees, set priorities, make sound Quality decisions, and hold a team accountable while maintaining effective working relationships., • Strong root cause analysis, organization, communication, and cross-functional collaboration skills., • Ability to manage changing priorities and urgent material requirements without compromising inspection quality or documentation accuracy., • Proficient in Microsoft Office Suite and able to enter, maintain, analyze, and retrieve inspection data in ERP, Quality Management, document control, and inspection systems., • Ability to analyze and communicate Quality metrics, inspection throughput, nonconformance trends, and improvement opportunities. Physical Demands/Requirements • Frequently stand, walk, use hands and fingers to handle components and measuring devices, reach, and perform inspection activities throughout the workday., • Frequently inspect fine details, read engineering drawings and electronic or printed records, and perform dimensional verification. Required vision abilities include close vision and the ability to adjust focus, with or without corrective lenses., • Occasionally bend, stoop, crouch, or access materials and inspection points in receiving, warehouse, and manufacturing areas., • Frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds with assistance or appropriate material-handling equipment when necessary., • Ability to wear required personal protective equipment and comply with all safety requirements., • Domestic travel up to 10%., • Frequent local travel between HYTORC facilities at 18 Industrial Avenue (Mahwah) and South Hackensack, New Jersey, is part of the regular day-to-day responsibilities of the position and is separate from the domestic travel requirement. Work Environment • This position operates primarily within inspection, receiving, warehouse, and manufacturing environments and requires frequent interaction with Quality, Engineering, Purchasing, Inventory, Warehouse, Supplier Quality, and Production personnel., • The role combines people leadership, technical quality leadership, and hands-on inspection responsibilities., • The work environment may include moderate noise, movement of materials, operation of inspection equipment, proximity to loading and receiving areas, and temporary temperature variations. Appropriate personal protective equipment must be worn where required. #ZR

Job Description Senior Manager Accounting Bergen County, NJ Reporting to: Director Accounting We are seeking a detail-oriented and proactive Manager to assist in overseeing core accounting operations, assist with the month-end close process, and support domestic and international audit and compliance requirements while driving financial accuracy, operational efficiency, and continuous process improvements across the accounting function. The ideal candidate is a strong technical accountant with leadership capability, attention to detail, and the ability to operate in a fast-paced, asset-intensive environment. Financial Close & Reporting • Assist in overseeing the month-end close process, ensuring timely preparation and review of journal entries, reconciliations, and financial reporting in alignment with internal deadlines, • Prepare and book payroll journal entries and related reconciliations, • Prepare and record monthly direct expense accruals, • Record and reconcile monthly financial activity for foreign offices, • Review and analyze financial results to ensure completeness and accuracy, • Prepare and review monthly cashflow activity, • Prepare quarterly financial statements for submission to Treasury, • Provide management with a weekly financial snapshot of SG&A and Direct Operating Expenses revenue to support strategic decision-making, • Provide support and assistance to Director and Controller for ad-hoc projects Audit & Compliance • Support year-end and interim U.S. audits, including preparation of schedules and coordination with external auditors, • Assist with the foreign statutory audits, • Coordinate preparation of audit deliverables and ensure timely responses to auditor inquiries, • Work with third-party vendors to manage foreign tax filings and ensure compliance with local regulatory requirements, • Assist with annual internal controls’ testing by auditing specific processes to ensure controls are sufficiently designed and are working as intended, • Team Leadership & Development, • Manage and mentor a team, • Review team deliverables to ensure accuracy and timeliness, • Provide coaching, performance feedback, and development support, • Process Improvement & Systems, • Champion continuous process improvement initiatives across accounting operations, • Identify inefficiencies and implement scalable, automated solutions, • Participate in ERP system enhancements, including user acceptance testing (UAT), data validation, and post-implementation support Education / Experience: • Bachelor’s degree in Accounting, • CPA a must, • 8-10+ years of progressive accounting experience and responsibilities, • Audit experience preferably from an accounting firm, • Experience supporting U.S. and international audits, • Exposure to foreign statutory reporting and tax compliance preferred Qualifications / Skills: • • Advanced skills in Microsoft Excel and business intelligence tools (PowerBI, Qlik), • • Strong knowledge of U.S. GAAP, • • Familiar with General Ledger systems, FSM preferred, • • Ability to multi-task in a fast-paced environment, • • Ability to understand and meet deadlines Core Competencies: • • Strong analytical and problem-solving skills, • • High attention to detail and commitment to accuracy, • • Ability to manage multiple priorities and deadlines, • • Effective communicator with cross-functional and international stakeholders, • • Proactive, solutions-oriented mindset, • • Strong partnering and collaboration skills required

Job Description As Sr. Quality Manager, you will be responsible for leading HYTORC's quality operations and supporting the continued development and effectiveness of the company's Quality Management System (QMS). This role will manage and support key quality functions, including Quality Engineering, Quality Control, Supplier Quality, Calibration, Document Control, Compliance, and related EH&S activities as assigned. The Sr. Quality Manager will help maintain compliance with ISO 9001:2015 and ISO 17025:2017 requirements, support customer, supplier, internal, and third-party audits, and drive practical improvements across manufacturing, distribution, assembly, machining, and final product verification activities. The ideal candidate will bring strong hands-on experience in quality systems for manufacturing and machining operations, from incoming material inspection through in-process controls, final inspection, and product release. Key Responsibilities Quality Systems & Compliance • Manage and continuously improve QMS processes, including internal audits, CAPA, calibration, complaints, inspections, risk management, and document control., • Serve as a key quality contact and support ISO Management Representative responsibilities as assigned., • Support notified body, customer, supplier, and third-party audits related to ISO 9001:2015, ISO 17025:2017, and other applicable requirements., • Maintain accurate compliance documentation and ensure procedures, work instructions, forms, and quality records are properly controlled and current., • Track and trend quality metrics; develop reports and dashboards to communicate performance, risks, and improvement priorities., • Support periodic Management Reviews by preparing QMS performance data, audit results, corrective action status, and quality trend information., • Ensure quality requirements are integrated throughout manufacturing, distribution, assembly, machining, and final product verification processes., • Verify QMS compliance through internal audits and ensure timely follow-up on findings, corrective actions, and effectiveness checks. Operational Quality & Performance • Collaborate cross-functionally with Engineering, Manufacturing, Machining, Assembly, Distribution, and Supply Chain to identify, contain, and resolve quality issues., • Lead root cause analysis and corrective/preventive action efforts to improve product quality, process capability, and customer satisfaction., • Manage quality requirements for incoming inspection, in-process inspection, dimensional inspection, assembly checks, calibration, and final product release., • Support production scale-up, new product introductions, and the implementation of new equipment with appropriate quality controls and validated processes., • Define, monitor, and report departmental KPIs; manage priorities, resources, equipment needs, and day-to-day quality workload., • Drive standardization of inspection methods, acceptance criteria, quality records, and nonconforming material processes., • Partner with internal teams to identify opportunities for continuous improvement and reduce repeat defects, rework, scrap, and supplier-related issues. Supplier Quality & Audit Support • Plan, support, and improve vendor and supplier audit activities to evaluate compliance with internal standards, contractual requirements, and applicable regulations., • Monitor supplier quality performance, incoming inspection trends, supplier corrective actions, and recurring nonconformances., • Work with Procurement and Supply Chain to support supplier qualification, corrective action follow-up, and supplier improvement initiatives., • Ensure supplier quality issues are documented, escalated, and resolved in a timely and effective manner. Team Leadership & Development • Lead, coach, and develop quality team members across assigned QC, QA, Compliance, Calibration, Document Control, and related functions., • Set clear expectations, priorities, and performance goals; promote accountability, follow-through, and timely issue resolution., • Support departmental training, onboarding, compliance awareness, and certification needs in partnership with HR and functional leaders., • Build a practical, results-oriented quality culture focused on prevention, problem-solving, data integrity, and continuous improvement. Safety, Regulatory & Sustainability Support • Support regulatory readiness and ongoing compliance with OSHA, UL, RoHS, REACH, Conflict Minerals, ISO standards, and other applicable requirements., • Support Safety Committee and EH&S activities as assigned and promote safe work practices within quality and operational areas., • Stay current with relevant industry standards and help prepare the organization for changing quality and compliance expectations., • Support sustainability and ESG-related data collection or reporting as it relates to quality, compliance, or operational performance. Issue Management & Communication • Manage escalated quality issues, audits, nonconformances, and product concerns with urgency, clarity, and professionalism., • Communicate quality risks, audit outcomes, corrective action status, and improvement plans to senior leadership and cross-functional stakeholders., • Use data, objective evidence, and sound judgment to support decisions and drive timely resolution of quality concerns., • Maintain discretion and professionalism when handling confidential information, audit findings, supplier performance, and employee-related matters. Required Qualifications • Bachelor's degree in Engineering, Quality Management, Manufacturing, or a related field; equivalent relevant experience may be considered., • 7+ years of quality experience within a manufacturing, machining, industrial, or related environment., • Minimum 3 years of experience leading, supervising, or managing quality personnel or cross-functional quality initiatives., • Hands-on experience with QMS processes, internal audits, CAPA, nonconforming material, inspection, calibration, document control, and management review activities., • Strong working knowledge of ISO 9001:2015; knowledge of ISO 17025:2017 strongly preferred., • Experience supporting customer, supplier, internal, and third-party audits., • Experience with CNC machining, precision assembly, dimensional inspection, and final product testing preferred., • ASQ certification such as CQE, CQA, or CMQ/OE preferred; ISO 9001 Lead Auditor certification preferred., • Working knowledge of OSHA, UL, RoHS, REACH, Conflict Minerals, and related standards preferred., • Strong command of MS Office Suite, ERP systems, document control systems, and quality data analysis tools; Minitab experience preferred., • Travel up to 10-30% (domestic and international) Key Competencies • Hands-on quality leader with strong operational discipline., • Clear, professional verbal and written communication skills., • Strong cross-functional collaboration and influencing skills., • Detail-oriented, process-driven, and accountability-focused., • Sound judgment and calm decision-making under pressure., • Strong problem-solving and root cause analysis capability., • Continuous improvement mindset using formal tools and techniques such as DMAIC, 5 Why, fishbone analysis, and corrective action methodology., • Ability to balance urgency, compliance, documentation discipline, and practical business needs. Cultural Fit & Leadership Expectations • Comfortable in a closely held, relationship-driven organization with direct interaction across leadership and operations., • Hands-on manager who is willing to engage at both the shop-floor and management levels., • Committed to transparency, accountability, process improvement, and long-term organizational success., • Able to build trust, reinforce standards, and support a culture of quality across departments., • Trusted to manage confidential information with discretion and professionalism., • Salary Range: $150,000 – $180,000 annually Actual compensation will be determined based on experience, qualifications, and business needs. This position may be eligible for bonus and a comprehensive benefits package, including medical, dental, vision, 401(k), and paid time off. #ZR\nCompany Description Industry leader with great innovation. Industry leader with great innovation.

Job Description JOB DESCRIPTION: Under the general direction of the Director of NKI, the Compliance Officer (CO) provides leadership and oversight for NKI's comprehensive Research Compliance Program. The CO ensures that research activities across the institution comply with applicable federal, state, and local regulations, sponsor requirements, and institutional policies. The CO oversees compliance across human subjects' protections, animal welfare, conflicts of interest, research integrity, bio-safety, privacy and data security, investigational drugs and devices, research billing, export controls, and grant/contract compliance. The CO promotes a culture of ethical, safe, and responsible research. JOB DUTIES: • Mentor compliance leads across functional areas (HRPP, IACUC, biosafety, privacy/security, research administration, etc.) to support effective operations and continuous improvement., • Audit, Monitoring & Investigations, • Conduct and prepare an annual risk assessment and compliance workplan, • Conduct or coordinate monitoring, audits, investigations, and assessments of potential noncompliance., • Serve as institutional liaison during internal and external audits and regulatory inspections; oversee development and implementation of corrective action plans., • Develop, monitor, and report compliance metrics to leadership, • Policy Development & Program Enhancement, • Develop, revise, and implement research compliance policies, SOPs, and guidance documents., • Maintain awareness of regulatory changes and ensure timely institutional updates., • Develop and implement training programs. Once established, the CO will proactively continue to develop new policies, programs, and procedures as needed to ensure that research compliance keeps pace with a dynamic regulatory environment and that the administration and constituents are kept aware of regulatory changes to mitigate unnecessary exposure to risk. Inherent in this work will be monitoring changes in federal regulations and state laws and, in turn, advising and educating institutional leadership, investigators, and staff on their impact on research compliance, human subject protection and animal research. The CO will ensure that research leaders and managers maintain continuously updated knowledge of current federal, state, and local regulations regarding research, including compliance with all required training and/or certifications. JOB QUALIFICATIONS: Minimum Qualifications: • An M.A./M.S. Degree or equivalent related experience., • A minimum of three years of experience in research compliance oversight in an academic medical center., • Comprehensive knowledge of ethical issues, state laws, policies, and regulations pertaining to the protection of human research subjects., • Demonstrated experience in guiding organizational compliance strategy, including implementing new initiatives and protocols., • Prior experience and proven success in establishing a culture of compliance across research units. Additionally, all candidates must be eligible to participate in Federal health care programs (e.g., Medicaid). Individuals excluded from participation in these programs will not be considered. Preferred Qualifications: At least one of the following: Certified IRB Professional (CIP), Certified Research Associate (CRA), Certified Clinical Research Associate (CCRA), or equivalent training or experience (such as an attorney or auditor with the necessary experience). Background Investigation/Justice Center Review Requirements: Prospective appointees will be: 1) Checked against the Staff Exclusion List (SEL) maintained by the Justice Center for the Protection of People with Special Needs. Prospective employees whose names appear on the SEL as having been found responsible for serious or repeated acts of abuse or neglect will be barred from appointment. 2) Screened against the Statewide Central Register of Child Abuse and Maltreatment (SCR). Prospective employees whose names are indicated on the SCR may be barred from appointment. *The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant. Applications will only be accepted through website at: http://corporate.rfmh.org - Click on Employment Opportunities. Applications will be accepted only during the posting dates as listed at the top of the job announcement. Questions regarding this position please email: hrprocessing@nki.rfmh.org Job Posted by ApplicantPro

We are seeking a detail-oriented and proactive Senior Accounting Manager to support key accounting operations, including the monthly close, financial reporting, internal controls, audit support, M&A integration activities, and functional oversight of the Accounts Payable and Billing teams. This role will partner closely with the Controller, Director of Accounting, AP Manager, Billing Manager, and cross-functional stakeholders to drive financial accuracy, operational efficiency, process discipline, and a strong control environment. The ideal candidate is a strong technical accountant with demonstrated leadership capability, experience working in a fast-paced and asset-intensive environment, and the ability to balance hands-on accounting responsibilities with oversight of operational finance functions. Essential Duties & Responsibilities: Financial Close & Reporting · Assist in overseeing the month-end close process, including coordination of AP, Billing, AR, accruals, subledger reconciliations, journal entries, account reconciliations, and financial reporting deliverables. · Review and analyze financial results, balance sheet accounts, AP/AR activity, direct expense accruals, and operational trends to ensure completeness, accuracy, and timely resolution of issues. · Partner with AP, Billing, Treasury, and Accounting team members to ensure recurring close activities, cash activity, customer billings, vendor payments, and subledger interfaces are appropriately recorded and reconciled. · Support preparation of management reporting, variance analysis, weekly financial snapshots, cash flow reporting, and other analyses used by leadership to evaluate business performance. · Record and reconcile monthly financial activity for foreign offices · Prepare and review monthly cashflow activity · Prepare quarterly financial statements for submission to Treasury · Support any M&A initiatives with due diligence, purchase accounting and integration topics · Support finance transformation initiatives, including close acceleration, reporting automation, workflow standardization, and improved use of data and business intelligence tools and any ERP implementations. · Provide support and assistance to Director and Controller for ad-hoc projects Functional Oversight – Accounts Payable & Billing · Supervise the Accounts Payable and Billing functions through the AP Manager and Billing Manager, ensuring timely, accurate, and well-controlled execution of departmental responsibilities. · Monitor AP and Billing workflows, deliverables, reconciliations, aging items, and issue resolution to ensure alignment with accounting close deadlines, company policies, and operational objectives. · Drive process improvements across source-to-pay and order-to-cash activities, including standardization, automation, documentation, control enhancement, and improved visibility into key operational metrics. · Support the development and monitoring of key performance indicators for AP and Billing, including timeliness, accuracy, aging, unresolved items, and process exceptions. · Provide leadership, development and coaching and performance feedback of functional AP and Billing managers, while promoting accountability, collaboration, and high-quality execution. · Foster a continuous improvement mindset across AP and Billing, encouraging proactive issue identification, ownership, and scalable solutions. Audit & Compliance · Support year-end and interim U.S. audits, foreign statutory audits, and other compliance requirements, including preparation and coordination of audit schedules, support, and responses to auditor inquiries. · Assist with annual internal controls testing, including walkthrough support, control documentation, review of design and operating effectiveness, evidence gathering, and remediation follow-up. · Partner with process owners across Accounting, AP, Billing, Treasury, Operations, and IT to maintain accurate process narratives, risk and control matrices, and supporting control evidence. · Identify control gaps, process inefficiencies, and opportunities to strengthen the control environment while balancing operational efficiency and audit readiness. · Support implementation of internal control enhancements resulting from audit findings, business changes, system implementations, acquisitions, or process redesign. Education / Experience: · Bachelor’s degree in Accounting · CPA required · 12-15+ years of progressive accounting experience and responsibilities · Experience over AP/Billing preferred · Audit experience preferably from an accounting firm · Experience supporting U.S. and international audits · Exposure to foreign statutory reporting and tax compliance preferred Qualifications / Skills: · Advanced skills in Microsoft Excel and business intelligence tools (PowerBI, Qlik) · Strong knowledge of U.S. GAAP · Familiar with General Ledger systems, FSM preferred · Ability to multi-task in a fast paced environment · Ability to understand and meet deadlines Core Competencies: · Strong analytical and problem-solving skills · High attention to detail and commitment to accuracy · Ability to manage multiple priorities and deadlines · Effective communicator with cross-functional and international stakeholders · Proactive, solutions-oriented mindset · Strong partnering and collaboration skills required All qualified applicants will receive consideration for employment without r

Internal Auditor – Bergen County, NJ.Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.Plan and execute ~10 audits annually.Assess risks, internal controls, and business processes.Document findings and present recommendations to man

Internal Auditor – Bergen County, NJ. Assess risks, internal controls, and business processes. Serve as Lead Auditor on a rotating basis.

Internal Auditor – Bergen County, NJ. Assess risks, internal controls, and business processes. Serve as Lead Auditor on a rotating basis.

Paramus, New Jersey, United States The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance. • 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 (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects., • 5+ years of pharmaceutical experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Paramus, New Jersey, United States 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. Key Responsibilities: • 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. Qualifications: • Bachelors degree in Life Sciences, Pharmacy, or related field., • 35 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., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

As Quality Manager, you will be responsible for leading HYTORC's quality operations and supporting the continued development and effectiveness of the company's Quality Management System (QMS). This role will manage and support key quality functions, including Quality Engineering, Quality Control, Supplier Quality, Calibration, Document Control, Compliance, and related EH&S activities as assigned. The Quality Manager will help maintain compliance with ISO 9001:2015 and ISO 17025:2017 requirements, support customer, supplier, internal, and third-party audits, and drive practical improvements across manufacturing, distribution, assembly, machining, and final product verification activities. The ideal candidate will bring strong hands-on experience in quality systems for manufacturing and machining operations, from incoming material inspection through in-process controls, final inspection, and product release. Key Responsibilities Quality Systems & Compliance • Manage and continuously improve QMS processes, including internal audits, CAPA, calibration, complaints, inspections, risk management, and document control., • Serve as a key quality contact and support ISO Management Representative responsibilities as assigned., • Support notified body, customer, supplier, and third-party audits related to ISO 9001:2015, ISO 17025:2017, and other applicable requirements., • Maintain accurate compliance documentation and ensure procedures, work instructions, forms, and quality records are properly controlled and current., • Track and trend quality metrics; develop reports and dashboards to communicate performance, risks, and improvement priorities., • Support periodic Management Reviews by preparing QMS performance data, audit results, corrective action status, and quality trend information., • Ensure quality requirements are integrated throughout manufacturing, distribution, assembly, machining, and final product verification processes., • Verify QMS compliance through internal audits and ensure timely follow-up on findings, corrective actions, and effectiveness checks. Operational Quality & Performance • Collaborate cross-functionally with Engineering, Manufacturing, Machining, Assembly, Distribution, and Supply Chain to identify, contain, and resolve quality issues., • Lead root cause analysis and corrective/preventive action efforts to improve product quality, process capability, and customer satisfaction., • Manage quality requirements for incoming inspection, in-process inspection, dimensional inspection, assembly checks, calibration, and final product release., • Support production scale-up, new product introductions, and the implementation of new equipment with appropriate quality controls and validated processes., • Define, monitor, and report departmental KPIs; manage priorities, resources, equipment needs, and day-to-day quality workload., • Drive standardization of inspection methods, acceptance criteria, quality records, and nonconforming material processes., • Partner with internal teams to identify opportunities for continuous improvement and reduce repeat defects, rework, scrap, and supplier-related issues. Supplier Quality & Audit Support • Plan, support, and improve vendor and supplier audit activities to evaluate compliance with internal standards, contractual requirements, and applicable regulations., • Monitor supplier quality performance, incoming inspection trends, supplier corrective actions, and recurring nonconformances., • Work with Procurement and Supply Chain to support supplier qualification, corrective action follow-up, and supplier improvement initiatives., • Ensure supplier quality issues are documented, escalated, and resolved in a timely and effective manner. Team Leadership & Development • Lead, coach, and develop quality team members across assigned QC, QA, Compliance, Calibration, Document Control, and related functions., • Set clear expectations, priorities, and performance goals; promote accountability, follow-through, and timely issue resolution., • Support departmental training, onboarding, compliance awareness, and certification needs in partnership with HR and functional leaders., • Build a practical, results-oriented quality culture focused on prevention, problem-solving, data integrity, and continuous improvement. Safety, Regulatory & Sustainability Support • Support regulatory readiness and ongoing compliance with OSHA, UL, RoHS, REACH, Conflict Minerals, ISO standards, and other applicable requirements., • Support Safety Committee and EH&S activities as assigned and promote safe work practices within quality and operational areas., • Stay current with relevant industry standards and help prepare the organization for changing quality and compliance expectations., • Support sustainability and ESG-related data collection or reporting as it relates to quality, compliance, or operational performance. Issue Management & Communication • Manage escalated quality issues, audits, nonconformances, and product concerns with urgency, clarity, and professionalism., • Communicate quality risks, audit outcomes, corrective action status, and improvement plans to senior leadership and cross-functional stakeholders., • Use data, objective evidence, and sound judgment to support decisions and drive timely resolution of quality concerns., • Maintain discretion and professionalism when handling confidential information, audit findings, supplier performance, and employee-related matters. Required Qualifications • Bachelor's degree in Engineering, Quality Management, Manufacturing, or a related field; equivalent relevant experience may be considered., • 7+ years of quality experience within a manufacturing, machining, industrial, or related environment., • Minimum 3 years of experience leading, supervising, or managing quality personnel or cross-functional quality initiatives., • Hands-on experience with QMS processes, internal audits, CAPA, nonconforming material, inspection, calibration, document control, and management review activities., • Strong working knowledge of ISO 9001:2015; knowledge of ISO 17025:2017 strongly preferred., • Experience supporting customer, supplier, internal, and third-party audits., • Experience with CNC machining, precision assembly, dimensional inspection, and final product testing preferred., • ASQ certification such as CQE, CQA, or CMQ/OE preferred; ISO 9001 Lead Auditor certification preferred., • Working knowledge of OSHA, UL, RoHS, REACH, Conflict Minerals, and related standards preferred., • Strong command of MS Office Suite, ERP systems, document control systems, and quality data analysis tools; Minitab experience preferred., • Travel up to 30-50% (domestic and international) Key Competencies • Hands-on quality leader with strong operational discipline., • Clear, professional verbal and written communication skills., • Strong cross-functional collaboration and influencing skills., • Detail-oriented, process-driven, and accountability-focused., • Sound judgment and calm decision-making under pressure., • Strong problem-solving and root cause analysis capability., • Continuous improvement mindset using formal tools and techniques such as DMAIC, 5 Why, fishbone analysis, and corrective action methodology., • Ability to balance urgency, compliance, documentation discipline, and practical business needs. Cultural Fit & Leadership Expectations • Comfortable in a closely held, relationship-driven organization with direct interaction across leadership and operations., • Hands-on manager who is willing to engage at both the shop-floor and management levels., • Committed to transparency, accountability, process improvement, and long-term organizational success., • Able to build trust, reinforce standards, and support a culture of quality across departments., • Trusted to manage confidential information with discretion and professionalism. Salary Range: $150,000 $180,000 annually Actual compensation will be determined based on experience, qualifications, and business needs. This position may be eligible for bonus and a comprehensive benefits package, including medical, dental, vision, 401(k), and paid time off. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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