
Quality Assurance Manager I
- Westerville, OH
- $85,000-150,000 per year
- Permanent
- Full-time
- Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
- Oversee the licenses, permits, and registrations process.
- Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable; reporting the results to executive management
- Ensure that systems and equipment are validated (if applicable) and change control processes maintained
- Hire, train, and develop quality associates.
- Monitor the training and development of site associates to ensure compliance to processes and regulations.
- Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops
- Review and provide recommendations on regulatory, customer and 3rd party audits.
- Review and identify trends within the quality assurance metrics for the organization.
- Primary customer contact for QA related issues/initiatives as needed.
- Develop, distribute and maintain regular management reports
- Manage site suppliers and prepare, receive, and act on audits
- Provide Business Development support and represent DHL in customer events and meetings as required
- Bachelor Degree or equivalent 4 years work experience, required
- Certification related to quality control, preferred
- 3+ years experience in a regulated environment OR ISO 9001 compliant or certified, required
- 1+ years of supervisory or management experience, required
- Manufacturing, Food, Life Sciences, or 3PL Industry experience, required
- Participation in successful standards organization registration in a complex environment
- Supervising or implementing quality control programs
- Knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
- Administrator of training in compliance to regulated standards
- People development
- People management
- Process development
- Sufficient computer application experience
- Strong written and verbal communication
- Data analysis experience
- Training and facilitation skills
- Self management
- Problem solving
- Project management
- Presenting
- Report creation
- Solution execution