Sr. QA Auditor

Morrisville, NC

Company Name :IBA Infotech LLC

Type : Contract

Primary Skills : Auditing, Product Quality Assurance, Certified Global Meeting Planner, Documentation Analytics

Location : Morrisville

CTC : DOE

Job Description:

Job Summary:

  • The auditor is able to perform routine auditing of pharmaceutical projects, using established procedures.
  • This position requires frequent independent judgment with limited supervision.
  • The work is routine and well defined.
  • Discuss actions to be taken with the supervisor before resolving issues.
  • As an experienced position, the auditor can work under general supervision and is able to perform more complex auditing of pharmaceutical projects and systems using established procedures.
  • Independently performs routine work with progressively more involved in recommendations for the improvement of the department.
  • Will make judgments on observations with limited supervisory review.
  • Position requires a high degree of initiative to resolve problems.
  • The work is routine to moderately complex but covered by well-defined policies and procedures.
  • Discusses actions to be taken before resolving routine problems.
  • Comply with divisional and site Environmental Health and Safety requirements.

Specific Duties:

  • Activities, and Responsibilities of time.
  • Audit a variety of methodologies as applied to various stages of pharmaceutical development. Verify accurate transcription of raw data into reports.
  • Audit above testing for compliance to all applicable SOPs and regulatory requirements.
  • Discuss issues with lab staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits.
  • Archive study phase documentation in a timely manner.
  • Identify potential compliance issues and takes corrective measures to prevent them, participating in assigned teams as required.
  • All other duties as assigned.
  • Job Requirements Education and Experience:
  • Bachelor’s degree in chemistry or closely related physical science from a four-year college/university or equivalent education and job experience
  • 7+ years related experience and/or training is required
  • Inhalations experience required
  • Analytical experience required
  • Extensive auditing experience required
  • Experience with QA document release required