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Job DescriptionJOB DESCRIPTION: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 Company’s 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 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 (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. QUALIFICATIONS:5+ years of pharmaceutical experience Must have experience with Radiopharmaceuticals and Quality 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

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 GMP Sr. Auditor Paramus, NJ If you post this job on a job board, please do not use company name or salary. Experience level: Mid-senior Experience required: 5 Years Education level: Bachelor’s degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No Job Summary: 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: 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. Ability to travel (up to 10%) for audits. Preferred Certifications: ASQ Certified Quality Auditor (CQA) ISO 9001 Lead Auditor GCP/GMP auditing certifications

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies. As a GCP Senior Auditor, you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment. This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations. Key Responsibilities Audit Leadership & Compliance Oversight • Plan, conduct, and manage global clinical process and vendor audits across multiple trials., • Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines., • Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors., • Develop detailed audit reports and manage related non-conformance items., • Ensure alignment with corporate Quality Management Systems (QMS) and Standard Operating Procedures (SOPs)., • Support regulatory inspections by preparing documentation and participating in audit readiness activities., • Bachelor's degree in a scientific, healthcare, or related discipline., • Minimum 5+ years of experience in the pharmaceutical or biopharmaceutical industry., • Strong background in GCP auditing and safety/pharmacovigilance., • Demonstrated experience conducting and managing internal and external GXP audits., • Proven knowledge of FDA, EMA, and ICH GCP regulatory requirements., • Familiarity with QMS, SOPs, and compliance documentation., • Experience auditing CROs, CMOs, investigator sites, and clinical vendors., • Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas., • Hybrid schedule: 3 days on-site (Tuesday-Thursday) in Paramus, NJ., • Flexibility is required as the on-site schedule may adjust over time., • Up to 10% travel may be required for audits and inspections.

Job Title: Auditor II Location: New Jersey (Newport) Pay: 58.28/hr Hours: 8 AM - 5 PM About the Client Our client is a leading international and multicultural financial institution, headquartered in Europe, with operations in over 60 countries and a workforce exceeding 180,000 employees. In the Client States, the client is primarily engaged in Corporate & Institutional Banking (CIB), with activities in Global Markets, Global Banking, Security Services, and asset management. Position Summary The client is seeking a contractor to support its Credit Risk Review team. The team s primary mandate is to: * Promptly identify loans with actual or potential credit weaknesses * Validate and, if necessary, adjust credit risk ratings * Assess the adequacy of internal credit policies, loan administration procedures, and compliance with applicable regulations Key Responsibilities * Participate in reviews of credit and counterparty risk across the CIB platform to detect weaknesses in credit approval and monitoring processes * Document review results and recommendations in written reports for senior management * Acquire a solid understanding of reviewed activities and associated industry risks * Assess adequacy and effectiveness of governance, management, and credit risk controls * Perform in-depth reviews of individual credits to: * Assess credit quality * Validate accuracy of counterparty risk ratings and loss given default (LGD) assessments * Recommend rating changes as necessary * Conduct thorough credit analyses covering: * Obligor s business and structure * Nature of bank facilities and exposures (corporate loans, complex loan/derivative products) * Capital structure positioning * Repayment sources, collateral, and legal documentation * Financial condition (profitability, balance sheet, cash flow, liquidity) * Re-perform rating methodologies and validate ratings * Evaluate the quality of credit analysis and underwriting performed by business and risk groups * Assess compliance with regulatory guidelines and client policies * Review complex financing structures and capital market products (swaps, derivatives, securitizations) and evaluate related risks * Identify and escalate actual and potential problem exposures * Assess adequacy of provisions for impaired credits, including independent discounted cash flow analysis if required * Ensure proper documentation, communication, and framework adherence * Deliver clear, concise written reports and effective presentations to management * Add value by raising relevant, actionable recommendations Minimum Qualifications * Bachelor s degree in Accounting or Finance (MBA, CPA, or CFA preferred) * 5 10 years of financial services experience in credit extension, underwriting, review, or analysis * Strong credit analysis skills with deep understanding of credit process and controls * Knowledge of leveraged lending and related regulatory guidance strongly preferred * Proficiency in MS Excel and PowerPoint * Strong verbal, written, and interpersonal communication skills * Comfortable presenting findings and recommendations to senior management with tact and professional assertiveness Preferred Qualifications * Experience across credit review, risk management, and origination (combination preferred, but strong expertise in one area considered) * Familiarity with regulated environments and large, global financial institutions

Job Description Job Summary: 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., • 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., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

AUDITOR II- TREASURY/FINANCE WHAT IS THE OPPORTUNITY?The auditor will work within a team and on occasion as an individual contributor on routine audit assignments testing internal controls and ensuring compliance with bank policies, procedures, and regulatory requirements. Assigned to one of the following areas: Financial, operational and process audits to assess the adequacy of the banks internal control environment. Fiduciary and private banking audits in corporate, employee benefit, and personal trust relationships, propriety mutual funds, security sales and trading, and insurance activities. Compliance with various laws, rules, regulation, and other regulatory pronouncements. What you will do • Completes time sheets and expense reports in a timely manner., • Complies fully with all Bank Operational and Credit policies and procedures as well as all regulatory requirements (e.g. Bank Secrecy Act, Know Your Client, Community Reinvestment Act, Fair Lending Practices, Code of Conduct, etc.)., • Completes all required training., • Develops a general knowledge of the business, regulatory and accounting and control environment in which City National Bank operates., • Keeps informed of new services, products and events that have a significant technology and business impact., • Keeps abreast of changes in the business, regulatory, accounting and control environment in which City National operates, particularly in areas where audit responsibilities are assigned., • Assists the Senior Auditor and or Audit Manager in the development of the audit scope., • Holds preliminary discussions and interviews with auditees prior to the beginning of the field work., • Prepares narratives/flowcharts detailing internal controls of area audited., • Documents the workflow in the area audited, develops audit programs or procedures, and updates audit programs as necessary., • Performs program procedures and documents work performed, test results and conclusions using work paper preparation guidelines., • Holds discussions/interview with auditee to gather information, obtains explanations and supporting data/information and documents audit findings and the conclusions drawn., • Keeps the Senior Auditor and/or Audit Manager abreast of progress, issues and audit matters as they arise., • Contributes to the drafting of audit observation sheets and audit reports., • Supports and or participates in audit exit meeting with management., • Bachelor's Degree or equivalent, • Minimum 3 years experience in performing internal control audits and risk assessments required., • Understanding of risks, internal controls, work paper documentation and issue identification concepts and experience in applying them to plan, perform, and report on the evaluation of various business processes/areas/functions., • Ability to work independently or under the guidance and supervision of a Senior Auditor., • Strong verbal and written communication skills, to effectively present to peers and management., • Ability to exhibit leadership skills needed to convey ideas and obtain management buy-in for constructive change., • Understanding of internal auditing standards, COSO and risk assessment practices., • Understanding of the technical aspects of accounting and financial reporting., • Experience in performing multiple projects and working with varying team members. Benefits and Perks At City National, we strive to be the best at whatever we do, including the benefits and perks we offer our colleagues. Get an inside look at our Benefits and Perks. ABOUT CITY NATIONAL City National Bank, a subsidiary of Royal Bank of Canada, is the largest bank headquartered in Los Angeles with $92.03 billion in assets as of April 30, 2024. Founded in 1954, City National provides personalized banking, investment and trust services in select markets including Los Angeles, Orange County, San Diego, the San Francisco Bay Area, New York City, Nashville, Atlanta, Delaware, Las Vegas, Washington D.C. and Miami.* In addition, the company and its investment affiliates manage or administer $96.83 billion in client investment assets. City National is dedicated to strengthening communities, and in 2023 alone, the company made more than $11 million in charitable contributions to nonprofits that support the communities it serves. *City National Bank does business in Miami and the state of Florida as CN Bank. For more information about City National, visit cnb.com. EQUAL OPPORTUNITY EMPLOYER & REASONABLE ACCOMMODATION City National Bank is an equal opportunity employer committed to promoting and maintaining a diverse, equitable and inclusive working environment where differences are valued and encouraged. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other basis protected by the laws or regulations in the locations where we operate or in our Code of Conduct. READ MORE If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation for any part of the employment process. Please contact us via email or leave a message at (213) 673-9139. These contact methods are dedicated to applicants whose disability prevents them from successfully applying online. Only messages left for this purpose will be returned. Responses may take up to two business days. Unless otherwise indicated as fully remote, reporting into a designated City National location is an essential function of the job. #LI-KTB #CA-KTB

We need a seasoned bank auditor. Internal Auditor - AML/Compliance Focus.

City National Bank, a subsidiary of Royal Bank of Canada, is the largest bank headquartered in Los Angeles with $92. WHAT IS THE OPPORTUNITY?The auditor will work within a team and on occasion as an individual contributor on routine audit assignments testing internal controls and ensuring compliance

Internal auditors at Quest typically have the opportunity to rotate into corporate finance or business operational positions based on performance and availability of roles as well as promotional advancement within the IA department. Reporting to an Audit Manager, the senior auditor position is instr

Possess Internal Audit experience and/or training. Internal Audit experience (preferred). As a Senior Internal Auditor, you will be tasked with objectively evaluating risks and analyzing processes and systems to keep our iGaming and online sports wagering operations in compliance with regulatory sta