Catalent Pharma Solutions Quality Control Operation Manager in Winchester, Kentucky

Job Description

Quality Control Manager – Operations

The Quality Control Operations Manager report to the Associate Director, Quality Control

Position Summary

Come join a dynamic and rewarding Quality Control Group. The Quality Control Operations Manager is responsible for providing leadership and monitoring day to day Quality Control 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, matrix, capacity management.

  • 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.

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

  • Manage laboratory safety program to provide the analysts a safe working environment and ensure laboratory meet the safety requirements.

  • Oversee the administrative function for analytical and microbiology laboratory equipment systems and software (e.g., Empower, LIMS, etc.) including purchase, calibration, qualification and requalification activities, etc. to meet the compliance (data integrity) requirements and project timelines.

  • Provide support to audits, deviations, OOSs/OOTs, unexpected events, lab investigations and Corrective and Preventative Actions.

The Candidate

  • Bachelor’s degree in a scientific discipline

  • Minimum of 5 years in pharmaceutical industry Quality Control laboratory and a minimum of 1 year of GMP Quality Control Laboratory management experience.

  • Must be able to interact with other departments within Catalent on daily basis and make extensive independent judgments

  • Strong leadership skills, driving accountability, compliance and efficiency

  • Strong Experience in applying GMP in QC lab in conformance to applicable regulatory requirements

  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

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 + 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

About Catalent

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. More products. Better treatments. Reliably supplied. ™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 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.

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 offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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.