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Remote Sr Compliance Specialist

Coon Rapids, MN 55448

Posted: 10/02/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614346 Is job remote?: Yes Country: United States

Job Description


Pay 65-85/h depending on experience

Top 3 things the manager is looking for: 
  1. Experience in a Quality role, preferably in a regulated environment, capable of maintaining quality in a fast-paced environment
  2. Capable of effectively managing multiple demands from a variety of sources
  3. Intermediate to Advanced Excel analysis experience, including use of functions such as VLOOKUP/XLOOKUP, Pivot Tables, and formulas.
TECHNICAL SKILLS
Must Have
  • • Capable of effectively managing multiple demands from a variety of sources
  • o Intermediate to Advanced Excel analysis experience, including use of functions such as VLOOKUP/XLOOKUP, Pivot Tables, and formulas.

Nice To Have
  • · Excellent written and verbal communication abilities.
  • · Experience in customer service or supply chain.
  • · Experience independently leading continuous improvement projects
  • · Experience supporting and participating in internal and external audits
  • · Experience with coordination activities for global enterprise compliance activities.
  • · Experience with ERP system (SAP).
  • · Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.
  • · General knowledge of Database Systems such as SAP, Siebel, Factory Works.


Top 3 tasks or responsibilities in scope for this role: Perform reporting and reconciliation activities on impacted product part of Field Corrective Actions (FCAs) to identify impacted consignees (i.e., Account) using the company ERP system (SAP) and other internal IT tools.
  1. Deliver and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.
  2. Identify, lead, and implement continuous improvement projects to increase effectiveness, efficiency, and compliance.


In this exciting role as a Sr. Compliance Specialist for the Field Corrective Action (FCA) Scoping Team within the Enterprise Field Corrective Action (FCA)and Product Hold Order (PHO) organization, you will be responsible for supporting all Operating Units (OU) for the FCA scoping and notification process.

This position involves coordination with a diverse group of stakeholders across the company including Quality, Distribution, Customer Service, Manufacturing, IT, and Global Regional Partners.

The individual for this role will need to work independently and as a team player with the ability to use sound judgement and work through ambiguous situations utilizing peers and leadership for assistance as appropriate.

Responsibilities may include the following and other duties may be assigned.
  • Prioritizes patient safety and regulatory compliance by acting swiftly in collaboration with cross functional partners to ensure timely FCA implementation.
  • Performs reporting and reconciliation activities on impacted product using the ERP system (SAP) and other internal IT tools.
  • Ensures FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements.
  • Identifies, leads, and implements continuous improvement projects to increase effectiveness, efficiency, and compliance.
  • Ensures alignment with legal and ethical standards of the organization.
  • 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.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • May act as a mentor to colleagues or may direct the work of other lower level professionals.
  • The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.
  • Differentiating Factors: 
    • Autonomy: Works independently under limited supervision to determine and develop approach to solutions.
    • Coaches and reviews the work of lower level specialists; may manage projects / processes.
    • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
    • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
    • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and
    • Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
Required Knowledge and Experience:
  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.
  • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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 Coon Rapids, MN

Ready to take your career to new heights? Discover exciting job opportunities in and around Coon Rapids, Minnesota. This bustling area offers a vibrant community, abundant recreational opportunities, and a thriving job market waiting for talented individuals like you. From catching a show at the Historic Mounds Theater to tasting the local favorite Jucy Lucy burger at the famous Matt's Bar, Coon Rapids has something for everyone. Explore job listings today and unlock your potential in this charming region filled with endless possibilities!

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.