The Manufacturing Quality Lead will provide leadership and technical solutions to the manufacturing and packaging of an Active Pharmaceutical Ingredient (API). To manage assigned operations and tasks in the API and other high-risk areas to meet the Argo Plant’s safety, quality, cost and customer delivery goals. Serves on task forces, cross-functional teams, committees, and works shift assignments in the department as needed.

Core Responsibilities:

• Monitor the day-to-day quality activities of the operators related to the API product to produce and package products of sufficient quality and quantity to meet the projected needs of customers and regulatory requirements.
• Holding operators accountable to the compliance of ICH Q7 and FSSC 22000.
• Delivering the training and coaching of operations personnel of API regulations.
• Review and investigate discrepancies for all API batch production and packaging records for accuracy, compliance to Ingredion, customer, and regulatory requirements driving to zero Good Documentation Practice (GDP) issues prior to submittal to Quality department.
• Review all changes for validation compliance to API procedures, process, equipment, and product for compliance to Ingredion, customer, and regulatory requirements.
• Lead API operations investigations related to the sampling process and manufacturing process Out of Specification (OOS) and customer complaints to ensure that the investigations are thorough, timely, unbiased, well-documented, and scientifically sound. Conduct and/or implement any necessary Corrective Action to prevent reoccurrence.
• Review all Operational Prerequisite Program records for Good Documentation Practices and applying effective corrective actions to prevent reoccurrence when monitoring actions plans are not followed and when devices are found not to be working as intended.
• Keeping historical data, analyzing and monitoring key efficiencies and parameters against design to assist Operations with troubleshooting and meeting costs and production goals.
• Compile manufacturing data as required for Annual Product Reports (APRs) and regulatory submissions.
• Ensure compliance of maintenance activities to meet API production needs of the business.
• Promoting Safety, Health and Environmental programs in order to ensure workforce stability, eliminating losses attributable to personal injury or property damage, and comply with regulatory guidelines applicable to manufacturing processes and product characteristics.
• Leading area tours for customers and audits as necessary.
• Being on call for off shift, weekends, and holidays as required.
• Experience working in a manufacturing environment in pharmaceutical, minimum 5 years required.
• Ability to perform effectively in high stress, emergency and crisis situations. Demonstrated ability to train, coach and hold others accountable to improve performance.
• Capacity to solve problems through creative, innovative solutions and challenge traditional methods of accomplishing tasks.
• Ability to build consensus and foster positive relationships.
• Ability to learn and apply Ingredion’s Safety, GMP, Continuous Improvement and Quality standards.

Qualified candidates will have:

• Bachelor’s degree in biology, microbiology, chemistry, chemical or mechanical engineering or equivalent in education and experience.
• Strong written and verbal communication skills. Ability to communicate across functional lines at all levels.
• Decision making ability, planning and time management skills.
• Initiative; be a self-starter and takes responsibility for personal actions, decisions and results.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Ingredion provides accommodations to job applicants with disabilities throughout the hiring process. If a job applicant requires an accommodation during the application process or through the selection process, we will work with the applicant to meet the job applicant's accommodation needs.

Job Type: Full-time

Pay: $77,800.00 - $97,100.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Bedford Park, IL 60501: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

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