Specialist

POSITION SUMMARY Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Specialist, Quality Assurance provides Quality Assurance support for GMP Raw Materials that support the production of GMP Manufacturing operations of cell therapy products at our US Cell Therapy facility located in Princeton, NJ. Responsibilities include providing QA oversight of materials used for Manufacturing, Quality Control, and Process & Analytical Development. Executing assigned quality tasks (including pre-approving instructions, reviewing documentation of executed instructions, reporting metrics, document drafting, report writing), providing review and approval of change requests (e.g., Trackwise change controls and EDMS document change requests), approving GxP deliverables, product specifications, reviewing and approving deviations, corrective and preventive actions, risk assessments, and reviewing resolution and effectiveness of corrective actions, and audit responses. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Role: Conducts critical reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form) by exercising judgement within defined procedures and regulations. Performs line clearance and QA on the floor activities; Review and dispositions batch records; Works with Materials Control to quarantine and disposition all GMP materials in a timely manner; Review and approve Deviations/Change Controls/CAPAs; Scanning and ancillary filing. Assists with the generation and/or revision of GMP documentation such as Standard Operating Procedures as it pertains to the disposition of Raw Materials. Support regulatory and client audit/inspections and supports internal audits of GMP systems and facilities. Works cross-functionally with Materials Control, Purchasing, Manufacturing, Quality Control and other departments to resolve raw material quality issues and provide assistance when needed; Continually evaluates Quality and Materials Control processes and procedures to improve efficiency and ensure compliance to appropriate GMPs. Collaborates with other members of Quality Assurance, including cross training where necessary, for performing duties and tasks in support of Catalent's Quality Systems; Performs Acceptable Quality Limit (AQL) visual inspection materials, as needed. Other duties as assigned. The Candidate: Bachelor of Science degree is required, Life Sciences discipline preferred 5+ years' experience within the biologic, biopharmaceutical, or regulated industry; 3+ years' experience in Manufacturing/Quality Assurance/Quality Control function preferred Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Knowledgeable and/or exposure to aseptic manufacturing processes including microbial and cell culture, and fill/finish; Raw Materials experience is a plus Creative individual with excellent trouble shooting and decision-making skills; Ability to quickly learn new and novel manufacturing processes supporting new clients; Able to work in a team setting and independently under minimum supervision; Requires the ability to produce results in a fast-paced environment to meet client deadlines; Able to effectively interpret new and existing global regulations; Able to communicate effectively with all levels of personnel and regulatory inspectors Experience or knowledge in Trackwise preferred This candidate will be required to support operations that may occur seven days a week. Why you should join Catalent: Defined career path and annual performance review and feedback process Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment 19 days of PTO + 8 paid holidays Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career. Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.