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Quality Assurance Leader
2 months ago
Natureplex, LLC is a reputable pharmaceutical manufacturer specializing in over-the-counter medications and electrolytes. We are committed to delivering high-quality products and are currently looking for a Quality Assurance Leader to join our dynamic team.
Key Responsibilities:
- Oversee the employee training initiatives, ensuring all training materials and documentation are up-to-date.
- Evaluate the effectiveness of quality processes, personnel, and methodologies to ensure compliance with regulatory and customer standards.
- Conduct tracking and trending analysis to monitor regulatory adherence, including:
- Incident Reports and investigations
- Corrective Action/Preventative Action Reports
- Customer Feedback and Complaints
- Document Control and Change Control
- Engage in customer and regulatory audits and inspections.
- Provide leadership and direction for the internal audit program.
- Utilize sound judgment to interpret requirements and ensure compliance.
- Manage departmental operations, including:
- Development and implementation of inspection and operational procedures
- Establishment of departmental budgets and guidelines
- Monitoring departmental resources to fulfill commitments
- Setting performance criteria and facilitating necessary training
- Communicating quality status to internal stakeholders and external partners
- Ensuring compliance with safety regulations and standards
Qualifications:
- Bachelor's degree in a scientific or technical discipline or equivalent experience.
- Proficient in computer applications, including Excel and Word.
- 3-5 years of direct management experience in a relevant sector, such as pharmaceuticals or medical devices.
- Familiarity with applicable standards and regulatory requirements, including ISO and GMP.
At Natureplex, we value our employees and offer a comprehensive benefits package, including paid vacation, medical insurance, dental and vision coverage, life insurance, and a 401k plan with company matching. We are an Equal Opportunity Employer and strive to create a safe and equitable work environment for all.