As a Pharmaceutical Quality Assurance Specialist, API your responsibilities will include: Perform batch record review on all API and NF batches. Monitor the day-to-day quality activities of the API to produce and package products of sufficient quality and quantity that meet the requirements of customers and regulatory bodies. Assist in deviation investigation program. Compile and approve summaries of API and NF product OOS Investigations Coordinate, review, approve and coordinate validation (lab, process, and method), qualification (DQ/IQ/OQ/PQ) and requalification activities. Use expertise to ensure methods/process/equipment/systems remain in a validated state. Analyze historical data, for key efficiencies and parameters against design to assist with troubleshooting and meeting Quality KPIs. Supports customer and regulatory audits as necessary. Being on call for off shift, weekends, and holidays as required. Conduct annual product reviews for API and NF products. Coordinate stability studies. Design and conduct training covering Pharmaceutical cGMPs and other regulatory requirements. Generate and analyze various quality metrics as needed. Assist in various quality activities as required. Assist in the quarterly compliance of API laboratory systems. Participate as auditor in the GMP and internal audit programs. Schedule Annual Product Review meetings with upper management and review results. Recommend course of action following conclusions drawn from annual review data analysis. Implement any corrective actions needed following any deficiencies found during batch record review, OOS/deviation investigation mock audit exercises. Oversee the management of change program for the active pharmaceutical ingredient. Assist the deviation investigation program and ensure compliance to the quality management, customer, and regulatory requirements. Coordinate & lead weekly meetings with Operations, Maintenance, Engineering and Quality Control groups for timely action completion. Able to contribute as a team member on Lean Six Sigma (LSS) projects. Quality representative for the Active Pharmaceutical Ingredient unit. The Quality Assurance Specialist, API position is well-suited for you if you have: Ability to prioritize and plan to support the QA team. Ability to manage control processes to meet regulatory requirements. Ability to work with others to maintain system changes, upgrades and managing control documents. Ability to provide 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 QA with pharmaceutical ingredients or products. Experienced with ICHQ1, 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. Strong interpersonal skills to execute and navigate day to day tasks. Relocation Available? No Job Grade: E What is the formula for a winning career? It starts with joining a thought leader, innovator and true high performer, grounded in values and driven to innovate and advance. As a Fortune 500 global provider of ingredient solutions, Ingredion offer great careers across various functions—corporate, scientific, engineering and operations, sales and technical service, marketing and more. If you are curious, confident, and believe in the power of game-changing ideas, we want you to make us part of your career formula. Successful: Grow with a leader. Ingredion is FORTUNE 500 company with consistently strong financial performance. Responsible: Thrive with an organization that lives its values. We drive relentlessly toward sustainable practices and responsible operations wherever we do business. Meaningful: Be proud of where you work and what you do. Ingredion enables innovation in foods, beverages and consumer products that touch lives around the world. 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. We are an equal opportunity employer and value diversity at our company. Ingredion seeks to provide a work environment that is free from harassment and discrimination. We will not tolerate any form of discrimination based on race, color, religion, age, gender, gender identity, gender expression, national origin, ancestry, handicap or disability—mental or physical—marital status, sexual orientation, veteran status, disability resulting from military service, or any other classification protected by law (“protected classifications”). We are committed to establishing and maintaining a work environment where everyone is treated with dignity and respect. Relocation Available: Yes, Within Region Ingredion is a leading global ingredients solutions company. We make sweeteners, starches, nutrition ingredients and biomaterials that are used by customers in everyday products from foods and beverages to paper and pharmaceuticals. We turn grains, fruits, vegetables and other plant materials into ingredients that make crackers crunchy, candy sweet, yogurt creamy, lotions and creams silky, plastics biodegradable and tissues softer and stronger. Our innovative ingredient solutions help customers stay on trend with simple ingredients and gluten-free or high-fiber foods that appeal to today's consumers. Grounded in our values of Care First, Be Preferred, Everyone Belongs, Innovate Boldly and Owner's Mindset, we employ approximately 12,000 employees around the world. Our customers operate in more than 120 countries and represent 60 diverse sectors, including food, beverage, paper and corrugating, brewing and other industries. Don’t see the dream job you are looking for? Share your contact information and CV/Resume - we will reach out for exciting career opportunities! We understand that to progress our Diversity, Equity and Inclusion (DEI) journey, we must be intentional and focused on our culture, measure our improvements, identify our opportunities and seek partnerships that make a difference. Through this work, we are fostering a company full of high-performing teams and bringing a global mindset to everything we do. Business Resource Groups (BRGs) and our councils are integral to the success of our DEI strategy and inclusive culture. Please ask your Ingredion connection about our Employee Referral Process!