Title: Quality Assurance Specialist (API)
Location: Bedford Park, IL (Argo)
Ingredion is hiring a Quality Assurance Specialist focusing on active pharmaceutical ingredient products (API). This role is responsible for leading quality assurance programs including Annual Product Review, Batch Record Review, Deviation/Out of Specification Investigation, Stability, and Validation. The position will provide quality leadership to the Argo plant to ensure the manufacturing process, quality systems and finished products comply with cGMPs and all applicable government, customer, and company expectations for quality and safety.
As a Quality Assurance Specialist, your responsibilities will include:
- Performing batch record review on all API and NF batches.
- Leading and managing the deviation investigation program and ensuring compliance to the quality management, customer, and regulatory requirements. Compiling and approving summaries of API and NF product OOS Investigations. Implementing any corrective actions needed.
- Conducting annual product reviews for API and NF products. Scheduling Annual Product Review meetings with upper management and review results. Recommending course of action following conclusions drawn from annual review data analysis.
- Authoring, reviewing, approving and coordinating validation (lab, process, and method), qualification (DQ/IQ/OQ/PQ) and requalification activities.
- Coordinating stability studies.
- Designing and conducting training covering Pharmaceutical cGMPs and other regulatory requirements.
- Generating and analyzing various quality metrics as needed.
- Participate as auditor in the GMP and internal audit programs.
- Overseeing the management of change program for the active pharmaceutical ingredient.
- Leading and managing the Material Review Board (MRB) including assigning action tasks and recording and dissemination of minutes.
- Contributing as a team member on Lean Six Sigma (LSS) projects.
- Acting as the Quality representative for the Active Pharmaceutical Ingredient unit.
- Assisting in various quality activities as required.
The Quality Assurance Specialist position is well-suited for you if you have the following:
- Ability to prioritize and plan to support the QA team.
- Experience in managing control processes to meet regulatory requirements.
- Working with others to maintain system changes, upgrades and managing control documents.
- Demonstrated leadership and guidance to operations and management staff.
Qualified candidates will have:
- Bachelor of Science Degree (i.e. Engineering, Chemistry, Microbiology, etc.) or significant experience in quality assurance/control, operations, analytical or other technical functional area.
- Three to five years experience working in Quality Assurance with pharmaceutical ingredients or products.
- Experienced with ICHQ1a, ICH Q7, ISO9001, 21cfr 210 and 211 HACCP, Food Safety and training.
- Excellent oral, written, and communication skills.
- Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point, Visio, flowcharting software and experience with Electronic Documentation Systems a plus.
If you are inspired by professional challenges and the rewards that come from a high level of performance, then Ingredion is the company for you. At Ingredion you can be a member of a globally connected team inspired to achieve great things.
We believe in the power of our people to work together to seize opportunities, overcome obstacles and exceed expectations. Each day, individuals make a meaningful difference in the quality of our products and the success of our technology and operations and, in turn, the quality of life for consumers.
A career at Ingredion combines the benefits and professional opportunities afforded a $7 billion leader in our industry with the dynamic environment and team-driven culture you’d expect in a much smaller company. Despite its global scope and the advancement opportunities that come with it, Ingredion has the intimacy of a mid-size company, one where different perspectives are sought and where relationships matter.