Job Title Quality Assurance Intern Requisition JR000014789 Quality Assurance Intern (Open) Location Hobart, NY Additional Locations Job Description Summary Mallinckrodt is a company united around a central pursuit – improving outcomes for underserved patients with severe and critical conditions. As a purpose-driven organization with a broad network and relentless determination, we create products, delivery systems and solutions for patients whose needs have not been met. Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty and generic pharmaceutical products and therapies. With locations in the US, Canada, Europe and Asia, culture is one of the most important aspects of our organization. Who we are at the core of our company - how we think, feel and work together means everything. We are anchored in our values of Patient Centricity, Innovation, Collaboration and Integrity. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. We are focused on listening for needs and delivering solutions. We provide medicines to address unmet patient needs, stemming from 155 years of using our unique strengths, experience and expertise to help improve people's lives. We know that we contribute to something that matters because we make quality products that impact patient lives. We have built an inclusive community and recognize the importance of every employee as a whole person – inside and outside of work. Our dynamic work environment provides unique experiences for employees to grow and develop. We are moving forward – come with us. The Program Mallinckrodt is offering an 11-week internship program, which provides an immersive experience in the world of pharmaceuticals. As an MNK 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. Mallinckrodt is united around our mission – Listening for needs. Delivering solutions. Join us to get a sense of what it’s like to work at Mallinckrodt and gain the real-world experience you are seeking. Job Description Improves safety, quality, and productivity of a fast-paced solid dose pharmaceutical operation. Consistently seeks for and evaluates methods to improve overall customer satisfaction through improved manufacturing efficiencies. Serves as main point of contact for manufacturing and/or packaging processes in their area in regard to safety, quality, and continuous improvement activities. + Department rep for FAT and SAT Documentation Completed + Coordinates the documentation of FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing). + Accurate, Up-to-Date SOP’s + Leads the SOP review process by actively managing procedural updates and driving cross-functional collaboration to meet due dates. + Manages tracking system to ensure effective communication on status of SOP updates. + Prepares reports for management on compliance. + Operations Documentation + Ensures rework costs are correctly identified and obtains approvals from client on how rework will be performed. Ensures rework is correctly completed. + Provide technical support and problem resolution. + New Product Launch Facilitated in Department + Assist in the successful and on time completion of documentation and implementation of new process and product transfers in assigned department. + Quality Processes Managed + Ensures the official documents receive appropriate sign-offs. Identifies and implements improvements to existing processes using continuous improvement tools. + Ensures that processes comply with all cGMP regulations in regards to process and cleaning validation. + Completes exception investigations and implements effective corrective and preventative actions to prevent recurrence. + Regular participation in production daily operations meeting and team problem solving efforts. + Work with plant safety to maintain process specific safety information. + Assist in developing training programs and/or SOPs to enhance skills sets and reduce defects. + Support Customer or Regulatory agency audits as the subject matter expert for assigned processes + Complete other necessary assignments as required including, but not limited to, department support tasks (filing, preparation of documents, etc.), document updates, participation in root cause analysis, and participation in investigations or internal audits. Minimum Requirements + BS degree or student in Industrial, Manufacturing, Chemical Engineering or Packaging Engineering/Technology or related field preferred. Solid knowledge of chemistry, physics and engineering principles. Organizational Relationship/Scope: + Drive for Results + Sets and maintains high performance standards for self and others that support the organization’s strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks. + Problem Solving + Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers. + Timely Decision Making + Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision. + Written Communications + Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect. Internship Duration: 05/19/25 - 08/01/25 Compensation: $23.00 - $25.00 per hour At Mallinckrodt, 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 Mallinckrodt and let’s do something dynamic together. Mallinckrodt 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 Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)