Regulatory Compliance Jobs

Position Responsibilities:

• ERP System Validation
• Policy/Procedure Development
• Assessments and Master Planning
• Software Quality Assurance
• Protocol Development and Execution

Skills, Knowledge and Experience:

• Professional with 8+ years experience within the Medical Device, Pharmaceutical and/or Biotechnology industries, preferably 4 years of which with a major consulting firm
• Strong project management skills
• Experience in providing guidance and support for compliance issues including cGMP Audits, Quality Systems organization and computer systems validation
• Extensive experience working in an FDA regulated environment
• Understanding of regulatory compliance requirements 21 CFR Part 11
• Experience with software implementations
• ERP Implementation and Validation experience (SAP, Oracle, BPCS or JDE)

This is a full-time position and the individual needs to be open to travel nationwide as well as internationally.

Knowledge, Skills, and Experience:

• Bachelor's Degree
• CPA and/or CISA is strongly preferred
• Prior experience in SOX testing
• Understanding of General IT Controls, test planning and execution
• Experience in preparing process control and flowcharts SOX compliance processes
• Excellent verbal and written communication skills
• Proficient in all Microsoft Office applications, including Project, Excel, Outlook, and Word

Knowledge, Skills, and Experience:

• Bachelor's Degree
• Excellent oral and written communication skills
• Excellent interpersonal skills, with ability to work with individuals at all levels
• Proficient in all Microsoft Office applications, including Power Point, Excel, Outlook, and Word
• Assist with recruiting and Human Resource functions
• Experience in handling general offices duties as assigned
• Dependable and Punctual

Knowledge, Skills, and Experience:

• Bachelor's Degree
• 5+ years of experience in Medical Device, Biotechnology and/or Pharmaceutical compliance, validation, manufacturing and engineering
• Knowledge of FDA regulated IT systems
• Experience developing validation plans, developing and executing IQ, OQ, PQ protocols
• Providing guidance and support for regulatory compliance issues
• Solid understanding of regulatory compliance requirements 21 CFR Part 11
• Development, testing and validation of regulated computerized cGMP, GCP and/or GLP systems
• Experience with automated testing tools and ERP packaged software

Ideal candidates will have a combination of experience in information systems, computer validation, software quality assurance, and ERP implementation.

We are seeking candidates with strong verbal and written communication skills, and a positive team and client interaction.

Open to candidates seeking both employee and contract positions.

Accountant Responsibilities:

• Prepare, examine, or analyze accounting records, financial statements, or other financial reports to assess accuracy, completeness, and conformance to reporting and procedural standards.
• Report to management regarding the finances of establishment.
• Establish tables of accounts and assign entries to proper accounts.
• Develop, implement, modify, and document recordkeeping and accounting systems, making use of current computer technology.
• Compute taxes owed and prepare tax returns, ensuring compliance with payment, reporting or other tax requirements.
• Maintain or examine the records of government agencies.
• Advise clients in areas such as compensation, employee h
ealth care benefits, the design of accounting or data processing systems, or long-range tax or estate plans.
• Develop, maintain, and analyze budgets, preparing periodic reports that compare budgeted costs to actual costs.
• Provide internal and external auditing services for businesses or individuals.
• Analyze business operations, trends, costs, revenues, financial commitments, and obligations, to project future revenues and expenses or to provide advice.

Auditor Responsibilities:

• Collect and analyze data to detect deficient controls, duplicated effort, extravagance, fraud, or non-compliance with laws, regulations, and management policies.
• Prepare detailed reports on audit findings.
• Supervise auditing of establishments, and determine scope of investigation required.
• Report to management about asset utilization and audit results, and recommend changes in operations and financial activities.
• Inspect account books and accounting systems for efficiency, effectiveness, and use of accepted accounting procedures to record transactions.
• Examine records and interview workers to ensure recording of transactions and compliance with laws and regulations.
• Examine and evaluate financial and information systems, recommending controls to ensure system reliability and data integrity.
• Review data about material assets, net worth, liabilities, capital stock, surplus, income, and expenditures.
• Confer with company officials about financial and regulatory matters.
• Examine whether the organization's objectives are reflected in its management activities, and whether employees understand the objectives.

Responsibilities:

• Expand or modify system to serve new purposes or improve work flow.
• Test, maintain, and monitor computer programs and systems, including coordinating the installation of computer programs and systems.
• Develop, document and revise system design procedures, test procedures, and quality standards.
• Provide staff and users with assistance solving computer related problems, such as malfunctions and program problems.
• Review and analyze computer printouts and performance indicators to locate code problems, and correct errors by correcting codes.
• Consult with management to ensure agreement on system principles.
• Confer with clients regarding the nature of the information processing or computation needs a computer program is to address.
• Read manuals, periodicals, and technical reports to learn how to develop programs that meet staff and user requirements.
• Coordinate and link the computer systems within an organization to increase compatibility and so information can be shared.
• Determine computer software or hardware needed to set up or alter system.