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Sr Compliance Specialist

Minneapolis, MN 55448

Posted: 11/20/2023 Employment Type: Contract Job Number: 591789 Is job remote?: No Country: United States

Job Description


Top 3 things the manager is looking for: 
  1. Prior experience with CAPAs in Medical Device
  2. Prior CAPA Owner or CAPA Specialist
  3. Process engineering i.e. Green/Black Belt work

Education Required: Bachelor’s degree

Years’ Experience Required: 5+
Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces antibribery and anticompetition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.
 
  • Provides Corrective and Preventive CAPA oversite and guidance.
  • Develops employee communication and training programs that focus on the elements of a companywide CAPA and compliance program.
  • Analyzes metrics and audits functional compliance program.
  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Minneapolis, MN

Ready to take the next step in your career? Explore our job opportunities in the vibrant Minneapolis, Minnesota area! Known for its picturesque lakes, thriving arts scene with renowned spots such as the Walker Art Center and Guthrie Theater, and home to the iconic Mall of America, this region offers a perfect blend of urban excitement and natural beauty. With top-tier professional sports teams like the Minnesota Vikings and Timberwolves, delicious local cuisine including Juicy Lucys and Scandinavian pastries, and an abundance of parks and outdoor activities like Minnehaha Falls and the Chain of Lakes, Minneapolis provides an unmatched quality of life for job seekers looking to grow their careers. Join us in discovering all that this charming and diverse area has to offer!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.