Responabilites:

• Oversee Quality Control Operations: Manage and oversee all aspects of the Quality Control department, including personnel, resources, and processes.
• Develop Quality Control Strategies: Develop and implement quality control strategies, policies, and procedures to ensure compliance with regulatory standards (e.g., FDA, GMP, ISO).
• Manage Testing and Analysis: Coordinate and oversee testing and analysis of raw materials, in-process materials, and finished products to ensure compliance with specifications and standards.
• Quality Assurance Compliance: Ensure that all quality control activities comply with regulatory requirements and industry best practices.
• Continuous Improvement: Identify areas for improvement in quality control processes and systems, and implement measures to enhance efficiency and effectiveness.
• Training and Development: Train, mentor, and develop quality control staff to ensure a high level of competence and expertise within the department.
• Quality Audits: Plan and conduct internal and external quality audits to assess compliance and identify areas for improvement.
• Documentation and Reporting: Maintain accurate and detailed records of quality control activities, test results, and compliance documentation. Prepare reports and presentations for management review.
• Supplier and Vendor Management: Collaborate with suppliers and vendors to ensure the quality of incoming materials and components.

Qualifications:

• Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biology, Pharmacy) required.
• Minimum of 5 of experience in quality control/assurance within the pharmaceutical industry, with [X years] in a managerial or supervisory role.
• In-depth knowledge of FDA regulations, cGMP guidelines, and quality management systems (e.g., ISO 9001).
• Strong leadership skills with the ability to motivate and inspire a team.
• Excellent communication, interpersonal, and problem-solving skills.
• Attention to detail and a commitment to upholding high-quality standards.
• Experience with quality control testing techniques and equipment.
• Certification in Quality Management (e.g., ASQ Certified Quality Manager) is a plus.

Job Type: Full-time

Pay: $85,000.00 - $110,000.00 per year

Experience:

• ISO 9001: 1 year (Preferred)

Ability to Commute:

• Indianapolis, IN (Preferred)

Ability to Relocate:

• Indianapolis, IN: Relocate before starting work (Preferred)

Work Location: In person