My name is George Rogers and I am a Recruiter with Kelly Services, Inc., a Fortune 500 workforce solutions company. We are currently seeking to fill an Audit Services Staff Specialist position in Portage, MI. I have attached the details of the opportunity below:
Duration: 12+ month contract assignment
Pay: $40.00 - $45.00/HOUR
The Audit Services Staff Specialist offers support to the organization by possessing and applying a broad knowledge and understanding of the regulatory and legal framework, regulatory requirements, legislation, process and procedures. This is demonstrated through supporting the Post Market Regulatory Compliance organization by reviewing and approving regulatory filing decisions along with performing internal audits in support of the Quality System Internal Audit Program.
- May review, approve and reject complaint investigations including regulatory filing decisions.
- May review and approve required reports, supplemental submissions and other post marketing commitments to update and maintain product approvals and registrations.
- Develop, modify and execute regulatory related company guidelines and procedures.
- Assist in the development and update of regulatory strategies based upon regulatory changes.
- May provide regulatory input into new product development and product lifecycle planning.
- May perform internal audits as assigned by Audit Program Manager including planning, scheduling, organizing, executing and creation of required documentation for assigned internal audits, using both practical and desktop techniques.
- Decide when a nonconforming event has occurred, originate, review and approve closure of non-conformances into eCAPA.
- May monitor audit non-conformances for trends and emerging issues, including industry surveillance of audit best practices.
- May maintain and monitor metrics for the Internal Audit program including communication to the organization.
- Research, analyze and communicate the appropriate interpretation of regulations and standards as it relates to implementation into the business.
- Assist in the training and mentoring of those associates supporting the team.
- Provide external audit support which may include Divisional representative activities.
- May assume Process Owner responsibilities for the Internal Audit Program which includes overall ownership of process and presentation in external audits.
- Manage and lead internal projects of a broad and complex nature.
- Directly correspond with Regulatory Agencies with minimal supervision, which may include assuming single point of contact responsibilities for the Instruments Division.
- Bachelor’s degree required
- 3+ years of experience in Manufacturing, focused in regulatory compliance and/or auditing.
- Experience working with CAPAs or Non-conformance reporting a plus
- Medical Device or Biotech/Pharma industry ideal
**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Please submit your resume to be considered for this position by pressing the “SUBMIT RESUME” button below. If you have questions about the position, you may contact the recruiter recruiting for this position (1-352-585-2109, URL blocked - click to apply), however, your resume should be uploaded via the “SUBMIT RESUME” button included within**
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