Operations Process Documentation Specialist

Catalent

Woodstock,IL  

2019-09-26 2019-10-26
records administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position 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 here











Position Summary







Catalent is looking to recruit an Operations Process Documentation Specialist to join a team at our site in Woodstock, IL.







The Operations Process Documentation Specialist will be responsible for authoring and processing Change Controls and CAPA in support of the Operations functions. This position will also have secondary responsibility for partnering with Project Managers to guide internal and external clients through the stages of the commercialization processes as they relate to manufacturing operations, including process guidance and document review. The partnership with Project Managers and internal/external clients will ensure a smooth development and transition from the Product Development group to the Operations group.







The Operations Process Documentation Specialist role is critical to our patients. This is a key role to ensure that quality drug products reach patients safely and efficiently. Quality, safety and on-time delivery is a must to be successful in this role!







The Role





+ Author Change Controls and related documents the for Operations team and partner with Continuous Improvement and Process Engineering for implementation of change controls



+ Review implemented Changes for completeness, accuracy, and compliance to cGMPs and SOPs



+ Own CAPA Problem Reports including Evaluations, Corrective Actions, and Effectiveness checks



+ Manage identified improvement requests from Operations floor



+ Author and Coordinate distribution of Awareness Trainings related to improvements



+ Partner with Project Managers to positively influence Operational capability



+ Demonstrate technical proficiency as Operations and Quality SME, an ability to collaborate with others, and independent thought



+ Work with multi-disciplinary project teams, comprising representatives from relevant functions



+ Create reliable documents for operational execution



+ Participate in PM teams as an Operations representative, cross site teams and functional teams in the PD/Operations Departments, Site or Global PM projects, activities and initiatives









The Candidate





+ Associate’s degree required; Bachelors’ degree is preferred



+ 5+ years’ experience within pharmaceutical operations manufacturing preferred



+ Knowledge of Operations, Pharmaceutical, and Biotech industries



+ Excellent written and verbal communication skills



+ Excellent client facing skills with a desire to meet and exceed client expectations



+ Proficient with MS Office programs









Catalent’s standard leadership competencies that are used to interview and for Performance & Development





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









Position Benefits





+ Potential for career growth within an expanding team



+ Defined career path and annual performance review and feedback process



+ Cross functional exposure to other areas of Catalent



+ Medical, Dental, Vision and 401K are all offered from day one of employment



+ 19 days of paid time off annually + 7 paid holidays









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.







personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/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 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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click 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.











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 Jobs@catalent.com. 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.
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