Documentation Specialist, QA

QA Document Control Specialist Position Summary QA Document Control Specialist is responsible for reviewing, implementing and maintaining change control to quality documentation and electronic systems such as the electronic batch record system and electronic weigh and dispense system per applicable SOPs. The primary tasks performed by this individual will include managing, maintaining, writing, and issuing standard operating procedures, batch records, standard test procedures, specifications, analytical methods, other quality documents, and writing and maintaining computerized system recipes. To accomplish these responsibilities requires experience and understanding of document change control procedures, computer systems, and philosophies within a cGMP environment. The Role Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model Work Orders, methods, etc.). Maintenance of the Document Change Request database. Maintenance of Quality Assurance files for Document Change Requests. Conducting lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS. Authoring and modifying SOPs with input from the change initiators. Maintenance of the Documentum database. Maintenance of the batch record suspension log. Ensures that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress. Work collaboratively with other QA Document Control team members to ensure that overall QA Document Control objectives are met. The Candidate Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination. A technical background and/or degree in a science (including computer science) is preferred. A minimum of 3 to 5 years’ experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), at least 1-2 years in the pharmaceutical industry is preferred. A minimum of 1-2 years’ experience authoring electronic batch record recipes is preferred. Why You Should Join Catalent Competitive medical benefits and 401K 19 days of PTO 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE. Catalent = Catalyst Talent Your 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.