Senior Quality Audit Specialist
On-siteAllentown, Pennsylvania, United States
Allentown, Pennsylvania, United StatesOn-siteFull TimeSenior LevelAssociates DegreeLarge
Full TimeSenior LevelAssociates DegreeLarge
Job Summary
Conduct customer, internal, and supplier audits by managing preparation, hosting, facilitation, response development, and closure to ensure regulatory commitments are met. Monitor and analyze trends in quality events, customer complaints, and change controls while acting as a backup Management Representative for FDA and regulatory inspections. Lead the development and submission of audit responses and corrective and preventive action plans, driving projects that improve operational quality. Troubleshoot complex quality issues through interdepartmental partnerships and train personnel on relevant business processes.
Required Qualifications
- Minimum 7 years relevant work experience in a cGMP environment
- Advanced knowledge of GMPs, GDPs, GLPs, Auditing and Quality Assurance/Quality Control skills
- Demonstrated ability to lead audit activities and compliance initiatives independently
- Ability to handle multiple tasks simultaneously
- Ability to negotiate and meet critical timelines
- Strong attention to detail
- Excellent organizational skills
- Experience with Microsoft Office applications
- Experience with quality management systems
- Ability to make sound regulatory interpretation
- Ability to employ logic
- Ability to implement decisions from within the QA organization
- Demonstrated ability for effective communication
- Demonstrated ability for teamwork
- Demonstrated ability for problem solving skills
- Quality Assurance experience in an operational or development setting
- Demonstrated knowledge of techniques for assessing the quality of processes
- Ability to guide others in these activities
- Adequate emotional intelligence to handle a variety of situations professionally
- Ability to handle situations in accordance with regulatory compliance
Desired Qualifications
- Bachelors' Degree, Associates Degree, or equivalent in science or technical related field preferred
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