Senior QC Scientist, QC Moda Administrator

The Senior QC Scientist, QC Moda Administrator responsibilities include technical support, configuration, administration, training and maintenance of the MODA application and those peers that use the software. The individual may be asked to participate/ assist in supporting internal projects and application updates as necessary. Furthermore, this position may participate in internal and external audits.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The role:

• Manages and maintains MODA while ensuring regulatory compliance.
• Builds and manages data as necessary for the QC EM department.
• Supports internal and external projects within the application.
• Develops and provides training to end users as necessary.
• Experience with System Design and development to ensure delivery of quality results.
• Perform or aid in Periodic User Access Reviews and Periodic Audit Trail Reviews of the MODA application.
• Effective communication with Quality Instrumentation Manager regarding status of daily work.
• Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the application of MODA.
• Drive improvements and efficiencies in the MODA process.

The candidate:

• Bachelor’s degree in science or related field required (Information Technology (IT), Chemistry, Microbiology or Biology preferred) or three to six years of MODA Administration and/or builder experience
• Ability to effectively present information and respond to questions from peers, management, regulatory and customers.
• Maintain and update associated standard operating procedures (SOPs) as necessary.
• Strong knowledge of Computerized System Validation (CSV).

The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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 Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Salary : $93,280 - $128,260