Associate Scientist - Quality Control

Overview

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

Position:
Associate Scientist I, Quality Control (QC) Environmental Monitoring. The role focuses on testing products, raw materials and the manufacturing environment to ensure Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. You will support evaluation of the effectiveness of microbial controls to prevent ingress of microorganisms in low bioburden products by performing routine and investigational sampling of the manufacturing environment and associated facilities.

Work Schedule:

Monday – Friday, core hours 8am-4pm. 100% on-site (Madison, WI).

• Performs solution preparations and facility monitoring of gas and water sampling. Log in samples into laboratory tracking software.
• Performs routine Environmental Monitoring (EM) in manufacturing environment: active air sampling, non-viable particulate monitoring, surface and personnel sampling.
• Performs general lab housekeeping in adherence to 5S standards.
• Stages materials/components for use within cGMP Quality Control lab.
• Accurately completes routine and preventive maintenance on basic equipment.
• Actively participates in team meetings and/or training sessions.
• Additional functions within the Quality Control department include technical data review, training, instrument maintenance, lead investigations, and laboratory information management system (LIMS) administration. These functions support the entire Quality Control department while performing their specific job functions.
• Other duties as assigned.

• High School Diploma or equivalent with four (4) years of industry experience is required. We will also accept the following experience and education combinations:
  Associate’s Degree and one (1) year of experience, or a Bachelor’s without formal experience.
• Must be able to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP.
• Must be able to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines.
• Ability to peer review data to ensure data is well organized with complete documentation. Strong proficiency in Excel, Word, and other office systems. Ability to perform basic arithmetic and ensure accuracy of results.
• Must be able to apply GMPs to everyday work with regard to documentation and instrument use.
• Ability to apply regulatory authority and guidelines with training.
• Preferred experience with writing technical documents, maintaining and troubleshooting Quality Control equipment, and familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
• Physical requirements:
  
  Vision, hearing and literacy in English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor. Reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional up to 50 pounds. Must comply with EHS responsibilities.

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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…