Site QA Manager

Spectron Rx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend, IN;
Bunker Hill, IN; and Danbury, CT with plans for additional future production facilities. We are seeking an experienced QA Manager to join our growing company. The Quality Assurance (QA) Manager will oversee quality assurance as it relates to management and compliance of the company processes and products in relation to established industry standards, specifications, and procedures, and to ensure the quality system is implemented and its integrity maintained.

• Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.
• Manage and maintain an effective Quality Assurance program for the plant in alignment with Global Operating Procedures and capable of maintaining ISO 9001 and 15378 certification status.
• Review operating procedures to ensure compliance with all related procedures, instructions, and the Quality Manual.
• Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
• Ensures timely resolution to customer inquiries (audit findings and complaints)
• Review customer requirements and make sure the system is in place to meet them
• Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports
• Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews.
• Conduct routine quality project management reviews with project Teams and management
• Drive continuous quality improvement projects at plant based on site data and customer expectations
• Drive compliance to global harmonization initiatives
• Conduct plant Quality Management Review meetings of the company quality system
• Establish and monitor plant Quality Metrics used to evaluate the effectiveness of the Quality System
• Manage Quality Staff at site to assure knowledge and execution of site Quality System
• Assure proper use of change management associated with validated processes
• Assure execution of internal audit program
• Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification and customer requirements
• Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
• Drive continuous quality improvement projects and global harmonization initiatives
• Utilize PMI strategies and techniques to manage Scope, Time, and Budget.
• Identifies and determines quality improvement
• Performs other related duties as assigned.
• Physical Ability – Must be able to lift up to 50 pounds at a time and stand for prolonged periods.
• Attention to Detail – Ability to accurately count, verify, and record data.
• Active Listening – Giving full attention to instructions and communications, asking questions as appropriate.
• Speaking – Talking to others to convey information effectively.
• Time Management – Managing own time to prioritize tasks and meet deadlines.
• Coordination – Adjusting actions in relation to others’ actions in a team environment.
• Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Written Comprehension – The ability to read and understand information and ideas presented in writing.
• Basic Math Skills – Ability to count accurately and perform basic arithmetic for reconciliation.
• Organizational Skills – Ability to maintain orderly areas and accurate records.

• Regular travel is minimal.

• Bachelor’s degree in…