Product Quality Release Specialist

Catalent

Winchester,KY  

2019-11-15 2019-12-15
quality 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











Product Quality Release Specialist







Position Summary



The Product Quality Release Specialist reports to the Product Quality Manager.







The Product Quality Release Specialist is responsible for coordinating Raw Material testing and disposition/release of Raw Materials for use in production. Serves as analytical and technical QA resident expert. Develops and supports departmental strategic goals for Catalent to assure the highest quality standards and regulatory compliance.







The Product Quality Specialist provides world class customer service, with the highest levels of integrity, focused on quality and compliance in partnership with Catalent customers and internal organizations. This position serves as a representative for their client(s) within the Catalent site.







Catalent's Winchester location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.







The Role





+ Oversee Raw Material Quality Control Data review and approval for release.



+ Raw Material Planning and Coordination with QC Raw Materials Manager.



+ Approve any required Hold/Reject transactions for raw materials



+ Release Raw Materials for manufacturing use. ***Will include after hours, weekend call-ins and limited travel to off-site warehouse.



+ Quality review for API’s, excipients for Quality Control laboratory as needed and OOS Approval and LIR Investigations development



+ Responsible to lead the change control process and manage the label control process for device labels.



+ Responsible for supporting internal, client, and regulatory audits through coordination and/or leadership of the audit backroom.



+ Effectively coordinates functions of internal QA organization with customers and necessary Catalent departments. Specifically: reviewing Raw Material Disposition/Release packets and support data, performing trending of product specific data, review and approve qualification reports.



+ Interfaces with the Catalent Operations Groups and Customer Service departments as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure highest quality standards and regulatory compliance.



+ Supports Catalent Quality Compliance department during FDA and other agency inspections as well as customer and internal audits.









The Candidate





+ Bachelor of Science in pharmaceutical applicable field; examples may include Science, Biology, Chemistry, or Engineering.



+ Five (5) years of experience in quality and/or regulatory in the Pharmaceutical industry, OR seven (7) years of experience in regulated industry with demonstrated understanding of laboratory, manufacturing, regulatory and compliance.







+ Experience working with third-party contract manufacturing in the Pharmaceutical industry preferred.



+ Demonstrated experience in successfully influencing others outside the incumbent’s department.







+ Must be knowledgeable in auditing principles and be able to audit/evaluate manufacturing and support functions at the site for customer and regulatory audit preparedness.



+ Knowledge of quality, regulatory and legal standards including USP, EP, JP, GMP, ICH, DEA and FDA.



+ Fully functional computer skills in Microsoft Word, Excel, and Power Point. Preferred experience in Trackwise and JDE.









Position Benefits





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



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









Leadership 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 Develops

















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.
Apply Now View all Catalent jobs Similar jobs Jobs near Winchester, KY