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Catalent Pharma Solutions Quality Control Manager in Winchester, Kentucky

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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Quality Control Manager

The QC Manager is responsible for providing leadership and monitoring day to day QC logistics operations to support Quality Control (QC) Department to meet cGMP compliance and project timelines.

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

  • Develop, coordinate and manage timelines for all Quality Control logistics activities including QC forecast, test/release schedule and matrix.

  • Attain the strategic plans, establish goals and objectives, supervise work practices, interprets and executes policies and procedures that typically affect organizational unit.

  • Responsible for management and tracking of outside laboratory raw material testing to meet production schedule and business requirements.

  • Oversee the scheduling and execution of raw material sampling, testing of raw materials, in process samples, finished products, stability samples, cleaning verification samples and analytical laboratory sample life cycle management.

  • Manage QC analytical change controls for test methods and specifications of raw materials, in process samples, finished products. Evaluate and implement program for reduced testing of raw materials.

  • Monitor USP/EP/JP compendial changes and assure applicable raw material and finished products specifications are compliant with current standards.

  • Oversee the data review group and ensure data review meet the cGMP compliance and complete on time to support project timelines.

The Candidate

  • Bachelors Degree in Microbiology, Biology or Chemistry (Preferred in Microbiology or Biology)

  • Work Experience – 5 to 10 years in a Microbiology Laboratory or Clinical role.

  • Masters Degree in Microbiology, Biology or Chemistry (Preferred in Microbiology or Biology)

  • Working Experience – 3 to 7 years in a Microbiology Laboratory or Clinical role.

  • Management Experience – Previous Supervisory preferred.

Position Benefits

  • Works cross-functionally and receives exposure to several departments

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

  • 19 days of paid time off annually + 8 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.

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 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.

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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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