Contract- AML Compliance Risk Analyst - New York, NY

DIRECT CLIENT

Role- AML Compliance Risk Analyst – III
Location- New York, NY 10045
Duration- 9 Months Contract
Description-
The Compliance Function is an independent advisory and control function within Client Client. The central mission of the Compliance Function is to protect the Bank and its people by fostering an ethical culture and ensuring appropriate risk-based compliance and ethics controls are utilized.
The Compliance Function also assesses risks related to sensitive data management, trading operations, and restrictions related to the Bank's code of conduct.
The Financial Crimes Unit ( "FCU”) in the Compliance Function is responsible for the development and implementation of the Bank's overall AML program and strategy, as well as Sanctions and Fraud policies, procedures, monitoring, research, due diligence, escalation, reporting and training processes. As one of only two such teams in the Reserve Bank System, the FCU provides an unparalleled opportunity to work on emerging financial matters of global importance, with a focus on mitigating the Bank's reputational AML and Sanctions related risks.
• Maintain effective relationships with first line of defense colleagues, business area management and staff to gain insight into financial crime related risks associated with business area activities, objectives, processes, and overall control environment.
• Support management in the creation and execution of program enhancements, including but not limited to documented guidance, training curriculums, escalation procedures and technological innovative solutions for key controls.
• Communicate effectively and professionally, both written and verbally with all levels management and staff regarding AML and Sanctions related matters.
• Conduct detailed and well supported investigations of transactions for the identification of suspicious activity and/or potential sanctions matches, documented with clear rational to support disposition determinations.
• Conduct detailed due diligence research, by using various research databases, on transactions and related parties, by evidencing detailed and concise written skills in documenting findings.
• Communicate due diligence findings concisely both written and verbally for presentation to senior stakeholders at the Bank.
• Develop, review and execute on FCU policies and procedures, controls, and identify opportunities for further program enhancement.
• Provide subject matter expertise and judgment on financial crime responsibilities, and other topics as assigned.

Quals--
• 5 to10 years of AML and sanctions compliance experience.
• Bachelor's degree required. Law degree or master's degree in business administration is a plus. CAMS Certification a plus.
• Knowledge of the Bank Secrecy Act (BSA) and the requirements of the Office of Foreign Assets Control (OFAC).
• Ability to communicate effectively with all levels of management and staff.
• Excellent written and verbal skills are a must, with the ability to communicate findings in a concise manner to all levels of management
• Ability to conduct independent research and investigations and produce reports and recommendations that translate an idea into appropriate action.
• Demonstrated ability to think critically, assimilate new information, make sound decisions, manage multiple responsibilities and respond effectively in time-pressured situations or to meet tight deadlines.
 
Thank You!!
 
Mirza Beg
APN Consulting, Inc. | Princeton Park Corporate Center
1100 Cornwall Road | Suite 205 | Monmouth Junction NJ 08852
Work: 609-924-3400 Ext: 208
Cell: (848) 238-1825
e-Fax 1-800-779-1202 | Fax 732-960-1638 
Email: mirza@apnconsultinginc.com

Senior Quality Engineer - Northern NJ - Direct Hire

 Job Title: Senior Quality Engineer

Status: Direct Hire 
Remote: No - Onsite Required in Northern NJ

We are currently seeking a Senior Quality Engineer, Software who will assist and support the organization with computer system and software validation activities. In this role, you will be responsible for performing assessments of computer systems and software processes within a regulated environment; compiling and maintaining the Validation Master Plan and procedures; as well as assisting functional/business owner in creating and executing the require system or software validation plans, documentation and tests.

Qualified candidates should be able to work with various business groups in order to support and provide timely implementation and a successful go-live of validated systems and applications.

Responsibilities

• Perform assessments of current non-device computer systems, applications and software and their related processes.
• Maintain the site’s Validation Master Plan and report in recurring status and review meetings.
• Prepare computer and software validation documents including validation plans, user and functional requirements, configuration specifications, test protocols, and reports.
• Support cross functional organization’s quality and GxP business needs and translate into user and functional requirements.
• Develop, maintain and update work instructions and procedures to define computer system validation standards, templates and processes.

 

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Sciences or a related field (Masters preferred)
• Minimum of 5 years’ Computer System or Software Validation experience in an FDA and/or ISO regulated environment
• Thorough understanding of FDA 21CFR 820 and ISO 13485 regulations
• Thorough understanding of software system verification/validation methodology
• Working knowledge and understanding of Good Automation Manufacturing Practices (GAMP)
• Experiencing in creating test protocols including IQs/OQs/PQs
• Understanding of SDLC and IT/System change management processes
• Project management experience in a regulated environment, preferably medical device, pharmaceutical, or health science as part of an interdisciplinary team
• Excellent problem solving, technical writing, and communication skills
• Must be self-motivated and detailed oriented
• ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) certification a plus

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*If interested, please send me your resume.

LORI MAGEE, CPSR, CPSAE
lmagee@talonpro.com

Recruiting Manager / Account Executive

Talon Professional Services

Regulatory Labeling Associate Role in Lawrenceville, NJ

Position Summary / Objective

The RIM Labeling Contractor is accountable to enter and manage regulatory information in the authoritative system. Specifically this individual will enter global labeling revisions of the Company Core Data Sheets (CCDS) for commercial products. Notifications of these regulatory changes are sent via a RIM workflow to country regulatory managers who assess it against the current local label and plan submissions. The RIM contractor will monitor data quality, accuracy, and ensure country-level data is available in a complete, and timely manner. Create reports/metrics to identify issues and analyze data trends. Function as a strong RIM user, interact with country regulatory associates, address questions and solve problems. Utilizing training on other regulatory processes, this associate will also support ad-hoc RIM requests. Participate in system testing for upgrades by executing scripts and being involved in validation.

Position Responsibilities
• Functions as a process expert for labeling submissions and CCDS updates in the RIM system.
• As a detail-oriented worker, manage daily workload independently understanding the business goals.
• Runs data quality reports to check process compliance on local assessments. Inform country managers of issues. Arrange meetings as needed to advise them on use of
the system and resolve the problems.
• Update data quality trackers and escalate issues when necessary.
• Use Excel to summarize information for inclusion in Power Point presentations provided to management.
• Contributes to and helps identify system and process gaps in labeling. Develop new RIM reports and dashboards.
• Provides support for internal audits, HA inspections and may be asked to contribute to the resolution of corrective preventive action plans.
• Executes operational tasks according to RIM procedures and work instructions.

Degree Requirements - BS/BA in a relevant scientific or technical field preferred

Experience Requirements
• Minimum of 3 – 5 years of relevant experience

Key Competency Requirements
• Demonstrates critical thinking skills and the ability to apply this to daily workload decisions
• Demonstrates awareness of the procedures and decision-making process of government Health Authorities and how it relates to RIM
• Strong understanding of regulatory operations
• Knowledge of computer systems in an R&D environment. Firm knowledge and experience with eCTD, SPL and submission standards. Ability to navigate marketing application submissions structure and content. Basic understanding of electronic records management rules
• Participates in projects and communicates and interacts with internal and external customers
• Practical experience with desktop application software suites
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills.
 
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to Axelon.  I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.

If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Contact
Shashikanth Bandapally
Recruiter
Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
Phone: (212) 488-7460
Fax  : (212) 306-0191
Shashikanth.Bandapally@axelon.com