What are the responsibilities and job description for the Compliance and Audit Specialist position at Planet Pharma?
Compliance and Audit Specialist
Contract Duration : Until 4 / 25 / 25 with the potential for extension
Work Hours : Full-time - 40 hours per week
Location : Minneapolis, MN – Onsite 3 days per week, remote for 2 days.
Target Pay Range : $60-$84.50 / hr.
Education : Bachelor's degree required.
Experience : Minimum of 2 years of relevant experience in a similar role.
Key Requirements :
Extensive experience with 21CFR820 , ISO13485 , and ISO14971 for Quality Management System requirements.
Internal audit experience is preferred but not mandatory.
Ability to work independently and effectively manage tasks with minimal supervision.
Strong communication skills .
Audit experience is preferred
Role Responsibilities :
Coordinate and / or prepare for internal and external audits , ensuring compliance with regulatory standards, including FDA and equivalent global regulatory agencies.
Interpret government regulations as they relate to products, processes, and procedures.
Develop and enforce policies and procedures to ensure compliance with relevant regulations, meeting all regulatory reporting requirements.
Investigate and resolve compliance issues from various stakeholders, including other departments, customers, and regulatory authorities.
Analyze audit data, present findings to management, and support Corrective Action Plans (CAPAs).
Assist in managing recalls and field actions as needed.
Develop and implement programs to increase employee awareness and understanding of compliance policies.
Position Overview :
Specialist Career Stream : Typically, an individual contributor responsible for specialized projects in a professional discipline. Works with other stakeholders to achieve project goals, may mentor colleagues, or direct the work of lower-level professionals. Most of the role involves delivering and overseeing projects, ensuring adherence to policies using specialized knowledge acquired through advanced education.
Key Differentiators :
Autonomy : Works independently with general supervision on larger, moderately complex projects.
Organizational Impact : Sets objectives for their area of work, contributing to the successful completion of projects and project milestones. May occasionally work on cross-functional assignments.
Innovation & Complexity : Faces general problems, which may require a broader understanding of different job areas. Suggests adjustments or improvements to systems and processes to enhance effectiveness.
Communication & Influence : Regular communication with internal stakeholders. External interactions tend to focus on information-sharing and problem-solving.
Leadership & Talent Management : May mentor entry-level professionals and / or provide guidance to employees within the Support Career Stream.
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