Senior Quality Auditor (home-based)

Overview:

Note: This role may be based remotely across the U.S.

With direction and oversight from the Head of Compliance and Quality or designee, the Senior Quality Auditor is responsible for planning and conducting audits and other consulting services (gap assessments/analysis, inspection preparation, Standard Operating Procedure writing/revising, validation support, Quality Management Systems consulting, etc.) to our clients as assigned. The Senior Quality Auditor will support other staff as a co-auditor including reviewing/editing client deliverables, such as audit plans and reports. The Senior Quality Auditor may also be responsible for directing or mentoring applicable staff and/or contractors/consultants.

The Senior Auditor is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.

Responsibilities:

  • Planning, conducting, reporting, and documenting GxP audits on behalf of clients either in a sole, lead, or co-auditor capacity
  • Supporting other auditors and applicable staff by reviewing/editing client deliverables and internal documents
  • Providing other consulting services to clients as assigned
  • Updating applicable departmental trackers, as assigned
  • Maintaining GxP knowledge and expertise relevant to applicable local and international regulations
  • Providing direction to staff temporarily assigned to consulting service project or departmental initiatives
  • As needed and feasible (based on departmental workload), the Senior Quality Auditor will perform or assist with any other tasks, programs, initiatives, or assessments as assigned by Compliance and Quality management or applicable executives.

Qualifications:

  • Bachelor's or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is required. An advanced degree is preferred.
  • At least five years of experience in the GxP industry and a sound working knowledge of the pertinent regulations and have verifiable experience independently planning, conducting, and reporting quality assessments including audits
  • Training: Current documented training in GCP; additional documented training in either GMP or GLP preferred.
  • Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
  • Candidate must demonstrate excellent writing skills, be an effective communicator (including public speaking), has exceptional organizational skills, ability to effectively perform independently in a remote setting, and be adept with applicable software systems.
  • Travel up to 50% may be required.

Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.

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