Primary Operations Supervisor
Description
The Primary Operations Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and assignments. Providing on floor support and review of MBR’s, providing coaching and feedback to operations team. Involvement in manufacturing deviation investigations and CAPA implementation. Influencing the accomplishments of companywide and team goals and objectives as well as inspiring team members while consistently modeling ALP values in all interactions.
This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) The Primary Operations Supervisor will constantly evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards.
This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) The Primary Operations Supervisor will constantly evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards.
Essential Job Functions:
• Provide technical support and project leadership in the implementation of visual inspection and packaging programs.
• Train operations and develop their capabilities to ensure formulation and filling programs sustainability.
• Serve as subject Matter Expert in formulation and filling technologies and quality/compliance requirements.
• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Knowledge of Aseptic techniques and processing
• Provide technical support, oversite and team leadership in manufacturing batch activities.
• Coordinate the development of individual team members with routine one on ones, training oversite and training opportunities.
• Develop and improve current processes to maintain and control the formulation and filling operations.
• Assure compliance with cGMP requirements (current good manufacturing practices)
• Perform GEMBA walks and checks for process improvements.
Special Job Requirements:
• BS or MS in Engineering or Science or 5 years related experience in the development or support of processes, quality systems or a closely related field.
• Must pass health and visual check and eye inspections annually.
• Provide technical support and project leadership in the implementation of visual inspection and packaging programs.
• Train operations and develop their capabilities to ensure formulation and filling programs sustainability.
• Serve as subject Matter Expert in formulation and filling technologies and quality/compliance requirements.
• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Knowledge of Aseptic techniques and processing
• Provide technical support, oversite and team leadership in manufacturing batch activities.
• Coordinate the development of individual team members with routine one on ones, training oversite and training opportunities.
• Develop and improve current processes to maintain and control the formulation and filling operations.
• Assure compliance with cGMP requirements (current good manufacturing practices)
• Perform GEMBA walks and checks for process improvements.
Special Job Requirements:
• BS or MS in Engineering or Science or 5 years related experience in the development or support of processes, quality systems or a closely related field.
• Must pass health and visual check and eye inspections annually.
Additional Preferences:
• Knowledge of statistics, process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Strong understanding of Visual Inspection and Packaging requirements.
• Knowledge of Aseptic techniques and processing.
• 2 or more years in a people leadership role.
• Knowledge of statistics, process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• Strong understanding of Visual Inspection and Packaging requirements.
• Knowledge of Aseptic techniques and processing.
• 2 or more years in a people leadership role.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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