Compliance Coordinator II
9965 Buffalo Speedway Gridiron, TX 77054 US
Job Description
Job Description
As part of the Quality Compliance Department, your primary focus will be ensuring compliance to regulations, standards, and company requirements. We strive to be always audit-ready by acting urgently to maintain a varied and robust quality management system. We foster an inclusive culture and welcome a diverse, talented workforce to join our company. As a Compliance Specialist, you will be trusted to provide expertise in regulations, standards, company requirements; and establish working relationships with the internal team of subject matter experts, certified investigators, auditees, and leaders throughout the organization. Key Responsibilities
- Perform quality audits of our quality management systems and processes.
- Administer the Trackwise ACE system by entering, querying, and monitoring data to support the site internal audit program. This includes opening, troubleshooting, and communicating the status of IT support tickets. Initiating and following up on requests for new TrackWise ACE users. Assist with the implementation of the new audit system, Siemens.
- Follow up on outstanding Audits, audit CAPAs and effectiveness checks by contacting and reminding auditors, approvers, and owners of upcoming due dates, facilitate use of the TrackWise ACE system for all auditors, auditees, and management.
- React to corporate procedure (CORP) revision notifications by reviewing, assigning actions in the TrackWise CAPA system, and coordinating with the assignees. Follow up and remind assignees to ensure CORPs are assessed and implemented at the site before the global due dates.
- Administer the Visuant system (metric database) including adding new users, updating users, and assisting with metric creation, manipulation, and maintenance as needed.
- Gather from various subject matter experts the required monthly metrics for our Quality Analytics reporting.
- Respond to quarterly Regulatory Intelligence reports by reviewing identified standards, coordinating with compliance leadership, and assigning actions to subject matter experts in the TrackWise CAPA system. Follow up and remind assignees to ensure standards are assessed and implemented at the site in a timely manner.
- Assist with coordination, set up, planning, and preparation leading up to and during health authority, notified body, and corporate audits.
- Update, maintain, improve Share sites for compliance teams.
- Query systems for metric reporting.
- Perform ad-hoc training, share best practices, and coordinate assistance for new or struggling subject matter experts who need assistance using TrackWise ACE, TrackWise CAPA, performing gap assessments, or improving procedures and processes.
Preferred Skills:
- 3 years directly related experience in GMP auditing.
- Knowledge of industry regulations, ISO 13485, MDSAP, MDR
- Microsoft Excel - proficient to expert
- Microsoft Word - proficient
- Microsoft SharePoint design- proficient to expert
- Microsoft PowerPoint - proficient to expert
- Technical writing experience
Soft Skills: The candidate will currently have the following soft skills that will ensure the professional integrity of the Compliance program:
- Strong leadership and communication skills (written and verbal).
- Sound decision making and organizational skills.
- Ability to present complex information to a variety of audiences.
- Familiarity with medical or manufacturing industry best practices and standard.
- Ability to handle conflict.
- Apply regulatory knowledge.
- Ability to evaluate and judge practices, root cause analysis, CAPA and effectiveness plans.
Education:
- Bachelors Degree or equivalent years of directly related experience (HS+10 yrs; Assc+6 yrs; M.S.+2 yrs)
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