Contract, Quality Assurance Operations Fellow

PTC Therapeutics, Inc
United States, New Jersey, Warren
Dec 18, 2024
Job Description Summary: PTC is proud to present the Talent Pipeline Program, a pioneering initiative aimed at cultivating the next generation of industry leaders. With a legacy of 26 years marked by resilience, innovation, and success, PTC understands the importance of investing in talented individuals who exhibit persistence and a strong work ethic. The Talent Pipeline Program is a one-year comprehensive training and real-world work experience opportunity tailored for recent university graduates. This program is designed to bridge the gap between academic knowledge and professional application, equipping participants with the skills and experience necessary to excel in their careers. At PTC, we believe in nurturing talent and providing a supportive environment where recent graduates can thrive. The Talent Pipeline Program is our commitment to empowering the next generation and investing in a brighter future for all. Job Description: Objective Provide Commercial program support to the Quality Operations team to meet milestones and improve processes Tasks/Responsibilities Completing all assigned tasks and assisting with day-to-day operations. Participating in meetings, workshops, and other learning opportunities. Observing and learning from experienced staff members. Gaining knowledge of company policies, protocols, and processes. Gaining knowledge of FDA and EMA cGMP (current Good Manufacturing Practices) regulatory requirements Gaining knowledge of QA oversight of external manufacturing and testing Working with Contract Manufacturing Organization (CMO) Taking detailed notes and liaising with Managers, Supervisors, and other senior staff. Fulfilling any requirements and meeting goals set out at the start of the Internship. Following all company regulations, and health and safety codes. Preparing and reviewing cGMP documents and updating records (internal and CMO/CTL generated) including but not limited to SOPs, incidents, complaints, exceptions, deviations, changes, batch records, and dispositions Laboratory methods, specifications, out of specification/expectation/tolerance, and data Experience / Qualifications Bachelor's Degreein Life Sciences, Engineering, or other technical field Excellent written, verbal, communication and interpersonal skills. Proficiency in Microsoft Office suite with strong working knowledge of excel, including writing Macro's and data manipulation Superb attention to detail. Strong leadership skills. A positive attitude and willingness to learn. Excellent time management skills. This is a one (1) year Talent Pipeline Program and the candidate/applicant must be able to complete the entire one-year program Fellow must be a recent college graduate For consideration, each applicant MUST answer the three (3) questions below in your cover letter to be considered for this one-year PTC Talent Pipeline Program. Why do you want to be part of this program? In what ways do you believe you can impact the future? What interests you most about this opportunity? EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Click here to return to the careers page