Site QA Manager SpectronRx

• 4.0 South Bend, IN Job Details $90,000
• $100,000 a year 1 day ago Qualifications Safety protocol adherence Client inquiry handling Incident Escalation Team development Driver's License Supervising experience Quality risk management Leading team collaboration initiatives Project management software Managing projects Escalation handling Project risk management Team motivation (leadership skill) Team building Full Job Description

COMPANY OVERVIEW

SpectronRx 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.

ESSENTIAL FUNCTIONS

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.

TRAVEL Regular travel is minimal.

REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in business, engineering, or field related to the products being developed required. Three to five years of experience in related field required with supervisory experience a plus. Superior organizational and leadership skills with ability to help team grow and thrive Experience with Customer interface and meeting customer expectations. Demonstrate team-building and problem-solving skills Ability to effectively prioritize and escalate issues Working familiarity with Project Management Tools and Quality Risk Management. Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc) Able to always comply with the company's safety policy Able to always comply with the company's quality policy

PREFERRED EDUCATION AND EXPERIENCE

Familiarity with a manufacturing or production environment. Certificate in quality assurance is a plus.

ADDITIONAL REQUIREMENTS

Valid Indiana driver's license. Pass a Background Check. Prolonged periods of standing, walking, bending, and lifting.

ADDITIONAL INFORMATION/BENEFITS

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process. We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.