Compliance Specialist Job

Job description

Compliance Specialist-5862150807DescriptionEthicon, Inc., a member of the Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization, within Johnson & Johnson's Family of Companies, is recruiting for a Compliance Specialist, located in either Somerville, NJ or Cornelia, GA.Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D organization supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
The Compliance Specialist under the supervision of Compliance Manager, will support implementation of the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements. Executes assigned Compliance functions to help site sustain a state of compliance to applicable regulations and directives such as FDA QSR, ISO13485, MDD, CMDR, TGA and ANVISA requirements. Participates in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directives in accordance with internal audit schedule. Supports implementation of inspection readiness activities and actively participates in conduct of external quality system audits and inspections. Supports maintenance of external audit and inspection response documentation. Serves on cross site project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. Manages assigned internal and external audit observations to ensure identified gaps are closed in a timely manner.
Other responsibilities of the Compliance Specialist will include providing support external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site; execute site inspection readiness actions/tools; participate in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.); as required, assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site; support mock inspections as part of External Inspection Readiness activities; provide timely information to support the inspection process; execute against established internal audit procedures; ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure; drive compliance and improvement in internal audit metrics; ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements; connect and collaborate with other regions compliance teams; create reports and communicate performance against metrics to key stakeholders; highlight/communicate adverse trends in metrics, and take risk based action to remediate; escalate items in accordance with established procedures; support implementation of new external standards/regulations for the site; maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings; provide input as directed (e.g., internal and external audit results/status) into Site Management Reviews, Corrective Action Review Boards and Plant Quality Reviews to allow meaningful review; participate in reviews as key stakeholder; establish strong connection and collaboration with business partners at the site, (e.g. Quality Operations, Training, Manufacturing); provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies; support and promote the safety and environmental objectives of the facility; comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001); support internal audit program as a team or lead auditor to ensure compliance; other tasks as assigned.
QualificationsHigh school degree with a minimum of 2 years of Quality/Compliance experience in a FDA regulated industry (pharmaceutical or medical devices) or a Bachelor's degree is required. Experience in Quality, Manufacturing or Engineering roles will be preferred. Experience leading internal quality system audits is preferred. Advanced computer and database management skills preferred. Experience in healthy authority and FDA inspections is preferred.
Knowledge of 21CFR 820, 21CFR 211, 21 CFR 4, ISO 13485, MDD, CMDR and ANVISA is preferred. Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs) preferred. Training in Process Excellence/Six Sigma tools and methodologies and Certification is preferred. Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification preferred. The ability to become certified within 1 year is preferred. Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Experience with Microsoft Project is preferred. Experience in leading and managing projects and milestones is preferred.
This position will be located in either Somerville, NJ or Cornelia, GA. If seated in Somerville, NJ up to 25% of domestic travel is expected. If seated in Cornelia, GA up to 10% of domestic travel is expected.
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Primary Location:North America-United States-Georgia-CorneliaOrganization: Ethicon Inc. (6045)Job Function: Quality (Eng)Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
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