QA Intern

Job Title QA Intern Requisition JR000015733 QA Intern (Open) Location College Park, Dublin - IRL006 Additional Locations Job Description Summary Job Description The Program Keenova is offering an internship program, which provides an immersive experience in the world of pharmaceuticals. As a Keenova Intern, you will have the opportunity to contribute to meaningful and impactful work that compliments the degree you are pursuing. Here, you will be able to apply what you’ve learned in the classroom to a corporate environment. In addition, our internship program is designed to include networking opportunities across the company, professional development workshops, and community service. Summary of Position The Quality Assurance Intern is responsible for maintenance of the Quality Management Systems within the College Park manufacturing facility. This position will have a wide range of tasks which include supporting performance of investigations related to deviations, nonconformances, and out-of-specification/out-of-trend events. The Quality Assurance Intern will also support the corrective and preventive actions that are identified as a result of those investigations. This individual will support the trending and metric reporting of the quality management system elements at the College Park manufacturing facility. Responsibilities · Help perform and evaluate trending of the Quality Management Systems to support management reviews, investigations, and continuous improvement initiatives (i.e. quality management reviews, annual product quality reviews, trend analysis for quality events, etc.) · Interpret and properly apply all applicable regulatory requirements · Support investigations through cross functional team involvement (i.e. RCA, etc.) · Improve existing procedures or create new procedures to align with cGMP and regulatory requirements · Review procedures, protocols, reports, etc., as required · Assist with continuous improvement, compliance-based, and site projects · Support lean manufacturing initiatives both at the site level and within the greater Quality/Operations organization · Participate in internal audits as a SME or member of the audit team · Perform additional duties as directed by management · Support the day to day management for QA Team and associated workload. Support other Quality functions at the site through cross-training opportunities Help drive Continuous Improvement projects on site from a Quality Perspective Ensure Compliance with current regulatory requirements Minimum Requirements Education / Experience / Skills: · Bachelor’s degree or higher in a scientific discipline (biology, chemistry or engineering) · Effective communication and presenting skills · Ability to manage change · Self-motivated · Independent and sound decision making capabilities · Team-oriented · Deliver on-time results / Time Management · Proficient with the Microsoft Office Suite, especially Excel, Word, and PowerPoint Relationship with Others/Scope of Position The Quality Assurance Intern collaborates closely with Manufacturing, Quality Control, EHS, Engineering, and Maintenance. This individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position’s working hours are during normal site hours M-F, but may be required to work extra hours or on weekends or holidays in order to support site activities. This position reports directly to the Lead, Quality Assurance. The Quality Assurance Intern will mainly work in an office environment but will also be required to work in the manufacturing and QC environments when providing QA support to those functional areas. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com. At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together. Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Keenova’s hiring practices may be found by clicking