Catalent Pharma Solutions Senior Quality Control Analyst in Winchester, Kentucky

Job Description

Senior Quality Control Analyst

Position Summary

The Senior Quality Control Analyst reports to the Quality Control Manager.

The Senior QC Analyst is a career level for top performing QC Analysts. Senior QC

Analysts deliver sustained contributions that result in new and/or improved processes and methodologies. Employees at this level can manage their time effectively and can function with minimal direction while executing a broad range of technical tasks. The Sr. QC Analyst is responsible for providing high quality and high volume analytical testing and productivity to support all scale up and commercial operations. Analysts at this level have demonstrated strong scientific and technical breadth or depth to support analytical test methods in a pharmaceutical manufacturing facility.

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

  • Has shown proficiency with the use and operation of basic laboratory equipment to support typical testing which may include Dissolution, Flame Atomic Absorption, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC. Exhibits the ability to effectively train others on proper use and maintenance of equipment.

  • Demonstrate strong skills/expertise/high proficiency on two or more specific analytical techniques listed above. For instance troubleshooting of: HPLC or GC instrumental problems, dissolution methods, or related substance assays. High throughput, based on level of difficulty, in areas of proficiency is expected.

  • With guidance and support, be able to execute method transfers

  • Able to author / review SOP’s that fall within defined area of subject matter expertise

  • Takes personal ownership in work and takes responsibility for all elements of their assignments.

  • Accurately interpret and effectively communicate analytical results and issues.

  • Calibrate and maintain lab equipment and instrumentation.

The Candidate

  • Education combined with Work Experience

  • Bachelors Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) with 5+ Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role

  • Masters Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) with 3+ Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role

  • PhD in Chemistry (Preferred in Analytical Chemistry or Pharmaceutical Sciences) with 1+ year(s) in a Quality, Laboratory or Clinical role (including time as a post doc)

  • Well rounded laboratory knowledge and skill set with the ability to perform routine testing such as Dissolution, Flame Atomic Absorption, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC with minimal guidance

  • Understanding of cGMP regulations and FDA/USP/EP/BP/ICH guidelines.

  • Flexibility to shifts is 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 + 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.