Compliance Staff Resume Sample
Scarlett Deckow
4196 Klein Ridge,
San Francisco,
CA
+1 (555) 655 9223
Work Experience
Staff Environmental Permitting & Compliance Specialist
05/2018
-
PRESENT
Phoenix, AZ
- Plan, coordinate, and conduct quality system audits of J&J Diabetes Care facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements. Facilities include worldwide operations, including the United States, Europe, and Asia
- Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures
- Review and monitor required corrective actions; conduct follow-up activities on required action items
- Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel
- Consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls
- Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues
- Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews
- Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the J&J portfolio, including medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions
Staff Trade Compliance
11/2011
-
04/2018
Chicago, IL
- Recent graduate to 2 years of relevant environmental experience or professional internships
- Excellent communication, interpersonal and organizational skills; experience writing comprehensive technical reports
- Quick learner, able to operate with minimal supervision
- In-field auditing experience
- Strong MS Office computer skills; advanced understanding of PowerPoint, Excel, and Access desired
- Excellent written and verbal communication skills; with experience delivering presentations and training subjects as well as writing comprehensive technical reports and standards
- Succeed in a fast-paced consulting environment, handling multiple project assignments, meeting strict deadlines, and traveling to client facilities as needed
Staff Environmental Compliance Consultant
06/2005
-
05/2011
Philadelphia, PA
- Review of existing documents (procedures, WI’s, etc.) for accuracy, robustness, and compliance
- Sound knowledge of cGMPs or equivalent regulations
- Interpret and relate quality standards for implementation and review
- Make sound GMP decisions, allocation of resources, and managing priorities
- Work independently and cross functionally in a dynamic environment
- Strong time management and prioritization skills to manage multiple projects with critical, FDA enforced, deadlines and tight budgets
- Prepare and help implement health and safety programs and provide training
- Perform environmental, health and safety compliance assessments at industrial and commercial facilities, and implement follow-up corrective actions to ensure compliance with federal, state, and local regulations
Education
Whitworth University
2001 - 2005
Bachelor's Degree in Engineering
Professional Skills
- Strong organizational skills to maintain and manage multiple validation projects
- Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes
- Critical thinking skills and a passion to work in a fast paced industry with complex/cutting edge technology
- Detail-oriented with hands-on trouble-shooting/problem-solving skills
- Experience with software development lifecycle activities, methodologies, testing and validation
- Articulate risk based validation strategy and provide tailored validation approach to meet the business needs
- Understanding of and experience with federal and state EHS regulations
How to write Compliance Staff Resume
Compliance Staff role is responsible for technical, interpersonal, reports, compliance, auditing, training, regulatory, travel, finance, integration.
To write great resume for compliance staff job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Compliance Staff Resume
The section contact information is important in your compliance staff resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Compliance Staff Resume
The section work experience is an essential part of your compliance staff resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous compliance staff responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular compliance staff position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Compliance Staff resume experience can include:
- Customer-focused with good communication skill
- Strong commitment to safety, including following established Health and Safety protocols and familiarity with OSHA requirements
- Two to four years of experience in environmental consulting, working on environmental due diligence projects and environmental compliance projects
- Experience in government compliance laws
- Experience related to FAR/DAR regulations
- Experience with enterprise applications such as SAP, LMS and EtQ
Education on a Compliance Staff Resume
Make sure to make education a priority on your compliance staff resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your compliance staff experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Compliance Staff Resume
When listing skills on your compliance staff resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical compliance staff skills:
- Experience in the systems quality discipline with extensive backend, integration project testing
- Experience in Quality, Compliance or Regulatory role in the medical device industry is required
- Work with highly technical teams and effective communicate in an engineering driven team environment
- Contributing, creating, and developing test automation strategies
- Knowledge of OSHA and CERCLA understanding in remedial design
- OSHA 40-hour HAZWOPER training is required
List of Typical Experience For a Compliance Staff Resume
1
Experience For Staff Trade Compliance Resume
- Provide general compliance support to clients, including on site support as needed
- Perform multiple projects within scope/budget/schedule expectations and ensuring quality standards on project deliverables
- Proficiency in Microsoft Office Word, Excel, and Power Point programs
- Conducts internal and external QSR/GMP/ISO quality system audits and follow-up activities. (50%)
- Assists project teams with identification of quality system requirements to ensure compliance. (15%)
- Monitors regulatory agencies for changes in requirements and evaluates impact to the organization. (5%)
- Provide technical assistance on EHS compliance and management system projects
2
Experience For Staff Facilities Engineer, Compliance Resume
- Assess clients' regulatory compliance across various environmental media and health and safety programs, analyzing large volumes of data in spreadsheet and database formats
- Familiarity with federal and state environmental, health and safety regulations
- Provide technical assistance on EHS compliance, sustainability, and due diligence transaction projects
- Prepare plans, permits, and reports for EPCRA Tier II and TRI, hazardous waste, air quality, storm water, NPDES, and wastewater programs
- Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the J&J Vision portfolio, including medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions
- Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, MDSAP, etc.)
List of Typical Skills For a Compliance Staff Resume
1
Skills For Staff Trade Compliance Resume
- Experience in the medical device industry and 8 years auditing per ISO and/or FDA standards
- Experience of conducting internal audits
- Manage the tracking of the corrective actions, including the electronic system
- Applied understanding of QSRs, cGMP, ISO 13485, ISO 14971, European Medical Device Directive, Canadian Medical Device Regulations (CMDR) etc
- Participate in design reviews as necessary to provide EMC compliance input during product development
- Identify and share industry trends through ongoing research
- Knowledge of Microsoft Windows, Excel and Word
- Understand the regulations and help interpret it for the company. Working knowledge of implementing, and providing guidance on domestic and international regulations
- Understand complex medical devices and regulations in the space of Capital Equipment, Disposable and Reusable product lines, Software Controls, Electrical Safety, wireless technology, RFID, etc
2
Skills For Staff Facilities Engineer, Compliance Resume
- Be a true team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use sound judgment in implementing practical Quality System and Compliance solutions
- Analyzes identified security strategies by assessing them against the organization’s needs and compliance guidelines and selects the best approach or practice for the enterprise
- Overall experience in audit activities
- Strong Knowledge of environmental regulatory guidelines
- Proficiency in English and Spanish (oral and written) is required
- Computer-literate in the use of Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required
3
Skills For Staff Environmental Compliance Consultant Resume
- Understanding world-wide Safety compliance standards for electronic products and electro-mechanical assemblies with a focus on data storage enclosures and appliances
- Participate in design reviews as necessary to provide Safety compliance input during product development
- Ensure compliance with all applicable Safety regulatory standards for our products in all major countries and geographies
- Proactively monitor and stay ahead of new Safety regulatory requirements and changes
- Understanding world-wide EMC compliance standards for electronic products and electro-mechanical assemblies with a focus on data storage enclosures and appliances
- Manage compliance documentation and equipment to satisfy customer and regulatory requirements
4
Skills For Staff Compliance Test Engineer Resume
- Ensure compliance with all applicable EMC regulatory standards for our products in all major countries and geographies
- Writing of pre-compliance test reports, review, approval and submission of final reports to regulatory bodies and all tasks associated with compliance and regulatory actions
- Manage external vendors, test houses and regulatory bodies to ensure proper completion of testing and submission of reports
- Lead technical discussions within the team and with other groups
- Proactively monitor and stay ahead of new EMC regulatory requirements and changes
5
Skills For Staff IT Quality & Compliance Analyst Resume
- Provide regular updates to program teams as required
- Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments
- Perform interpretation and analyses of international standards and regulations and document gaps, where appropriate
- Review and approve checklist changes and amendments
- Serve as a liaison for the compliance team to other functional groups and facilities
- Drive consistency of compliance team practices
- Manage internal and external team SharePoint sites
- Create monthly report for internal and external compliance observations
6
Skills For Staff EMC Compliance Engineer Resume
- Support and maintain recall log and files
- Develop tools to streamline audit consistency
- Update compliance team documents, as requested
- Support quality initiatives, goals, and metrics
- Plan, coordinate, and conduct quality system audits of J&J Vision facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements. Facilities include worldwide operations, including the United States, Europe, and Asia
- Provide support to the CMD segment in the performance of audits or audit related activity
- Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures
- Experience with Test Management Tools such as HP Quality Center and TFS
7
Skills For Staff Environmental Permitting & Compliance Specialist Resume
- Experience and leadership in fast-paced project implementations
- Experience with regulations and frameworks – e.g., 21 CFR Part 820/11, ISO 13485, SOX, HIPAA and GAMP
- Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS
- Conduct environmental field work, including air, groundwater, soil, sediment, and surface water sampling and ecological field studies
- Support teams in designing and implementing EHS management systems and programs for clients
8
Skills For Cyber Governance Risk Compliance Staff Resume
- BS in Engineering, Geology or Environmental Science
- Provide general EHS compliance support to clients, including on-site assistance, as needed
- Acts as liaison with external auditors during third party/regulatory audits. (10%)
- Sound knowledge of cGMPs, ISO 13485, and FDA CFR 21 Part 820 regulations
- Solid knowledge of ASTM Phase I standards, understanding of core business and legal concepts of business transactions, and continued interest in working on transactions
- Relevant environmental experience or professional internships
- Familiarity with USEPA and State environmental regulations and understanding of environmental permit application processes; preference given to those with experience in environmental compliance auditing
- Assist in preparing permit applications where required by federal, state or local environmental regulatory authorities for energy development, expansion, maintenance, or decommissioning projects
9
Skills For Staff Compliance Specialist Resume
- Perform project delivery activities such as report writing, data collection and survey field work, data and literature review, and development of recommendations for clients
- Collaborate with other ERM practitioners to execute impact assessment and capital project permitting (ERM services broadly include environmental impact assessment, routing studies, land planning, facility siting & permitting, and risk assessment and water resources management)
- Environmental impact assessment and natural resources permitting experience, including consulting for private-sector clients
- Travel up to 20% of the time, for agency meetings, project team meetings, or to conduct site visits, environmental training, or fieldwork
- Experience conducting desktop and online studies or research on natural resource or resource planning topics, Geographic Information System, map interpretation (National Wetland Inventory, U.S. Geological Survey, aerial photography)
- Demonstrated ability to research and prepare concise and accurate technical documents
10
Skills For Staff Regulatory Compliance Engineer Resume
- Recent graduate, 0 to 2 years of relevant environmental experience or professional internships
- Relevant environmental experience or professional internships
- Work both independently and as a collaborative member of a project team
- Excellent interpersonal communication skills, which includes being comfortable and effective at communicating complex technical knowledge and concepts to other staff, clients, regulatory agencies, and project stakeholders
- Prepare plans, permits, and reports for hazardous waste, spill prevention, air quality, and water quality programs
- Support the development and implementation of EHS compliance and management system programs
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