Job DescriptionPosition Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start herePosition SummaryThe QA System Specialist reports to the Manager QA. The Quality Systems Specialist is responsible for the development, execution and management of the complete Quality Systems. This position will assist in identifying and creating a resolution for quality issues and regulatory concerns.The Role+ Identify and resolve quality problems, address regulatory concerns, and accepts special projects and miscellaneous duties as required;+ Takes an active QA role in the development, execution and management of documentation control, specifications, risk management, action and alert limits, change control, batch record review, supplier qualification, customer complaints, QA/QC/GMP training, process improvement, annual reviews, and trend analysis;+ Manages the execution and completion of OOS investigations, Non-Conforming Event Reports (NCR), Temporary Change Requests and Engineering Change Requests;+ Reviews qualification protocols, process validations, C of As, C of Cs, calibration and preventive maintenance records, etc. for completeness;+ Provides technical expertise and guidance in GMP compliance for Operations and QC Laboratories;+ Develops Preventive and Corrective Action Plans to reduce or eliminate manufacturing defects, NCR's, OOSs, and increase work-flow efficiency;+ Writes, revises, assists in writing and reviews SOPs;+ Conducts internal and external audits+ Monitors equipment and area cleans along with general housekeeping practices;+ Assists with sample and documentation retention;+ Evaluates technology transfers associated with new products or processes;The Candidate+ Bachelor's Degree with emphasis on science / life sciences with 3 - 5 years related experience and/or training within a pharmaceutical or FDA regulated business;+ Working knowledge of GMP and GLP;+ Ability to read and interpret FDA Guidelines, professional journals and technical procedures;+ Strong leadership, organizational, multitasking, problem-solving, math, statistical, interpersonal, written and oral communication skills. Detail-oriented and ability to work within multifunctional teams;Position Benefits+ Opportunity to work with a growing department with high visibility to Senior Leadership+ Medical, Dental, Vision and 401K are all offered from day one of employment+ 19 days of paid time off annually + 7 paid holidaysLeadership Competencies for Performance and Development+ Leads with Integrity and Respect+ Delivers Results+ Demonstrates Business Acumen+ Fosters Collaboration and Teamwork+ Champions Change+ Engages and Inspires+ Coaches and DevelopsCatalent 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. personal initiative. dynamic pace. meaningful work.Visit ~~~/careers to explore career opportunities.Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.Catalent = Catalyst + TalentYour talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!personal initiative. dynamic pace. meaningful work.Catalent is the perfect place to grow your career if...+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to ~~~. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.