Randstad is looking to hire a passionate Compliance Specialist. The perfect candidate has experience working with medical devices in a highly regulatory environment. This is currently set at a 6 month contract but has high potential to extend. This role requires someone to be very detail oriented and highly organized. This role will require you go onsite. If you are a Compliance Specialist looking for high growth potential, please see the description below.
location: Murrysville, Pennsylvania
job type: Contract
salary: $1 - 65 per hour
work hours: 8am to 5pm
- Support the Central Privacy Legal Compliance Function and Privacy Compliance Priorities
- Maintain relationship and continuous communication plan with BG/Functional leaders and execute the Privacy Champion Program
- Use Data Mining Techniques and automated analytical tools to extract data from complex systems, analyze company-wide operational information and identify trends/metrics.
- - Compile and communicate operational information, including metrics and significant trends, to management and other stakeholders.
- - Perform analyses and continuous monitoring in support of internal audits, management reviews, consulting requests and external audits
- M&A, Remediation, and Response Reviewers work at a global level across company organizations:
- - Assists identified organizational units in addressing compliance deficiencies.
- - Supports due diligence, integration and remediation activities in coordination with the M&A organization.
- - May also provide other compliance support, including reviewing responses to audit findings for completeness and effectiveness and providing training on key
- compliance topics.
- Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function.
- Viewed as an expert in the field.
- May have a leadership role.
- Has expert level knowledge of company products and services and may be tasked with introducing new concepts.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
- Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
- Expert and technical lead with proven experience.
- Review gaps found in various Quality Management Systems such as Management Review and Internal Auditing.
- Providing support to the Quality System readiness project by assessing and reporting on gaps found in various Quality Management Systems such as Management Review and Internal Auditing.
- Additional support is being provided to work on CAPA actions needed to address non-conformances detected during various internal audits.
- Facilitate / execute document workflows
- Identify and propose solutions to potential nonconformance(s)
- Manages document change requests for customers as needed
- Review / edit user documents for compliance with current templates and procedures
- Track and report status of documents/records in system
- Support the documentation and management of changes
- Support the revision and/or creation of department specific procedures and work instructions.
- Supports Quality Documentation Control system and its related processes, including coordinating the revision, review, and approval of SOPs and other documents and ensuring compliance with applicable standards and regulations.
- Activities includes, but is not limited to, document control function, including document login, tracking, processing, distributing, and archiving; processing QMS records such as events and CAPA
- Support the compilation of QS metrics; and participating in internal audits and supporting external audits.
- Experience level:
- Minimum 6 years of experience
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.