Scientist I - Quality Control (2nd shift)

Catalent•Madison, WI

1d•Onsite

About The Position

Scientist I, Quality Control (2nd shift) Position Summary: Work Schedule: Mon-Wed 12pm-12am OR Tues-Thurs12pm-12am 100% on-site Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. Catalent Pharma Solutions in Madison, WI is hiring a Scientist I, Quality Control. The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment to ensure the Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. This position requires a variety of skills necessary for biotech company operations. Perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. Position will Analyze and interpret results in written and oral format. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review and contributions to process improvement initiatives.

Requirements

Master’s Degree in Biology, Biotechnology, Chemistry or related life sciences field
Bachelor’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 3 years of industry experience
Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience
High School Diploma or equivalent with a minimum of 7 years of industry experience

Nice To Haves

Strong understanding of analytical chemistry and simple and moderately complex lab equipment preferred
Familiarity with clean room procedure, aseptic technique, and general lab equipment experience preferred
cGMP, Good Documentation Practices (GDP) or Good Laboratory Practices (GLP) knowledge preferred
General laboratory equipment experience, including micropipettes preferred

Responsibilities

Independently executes and properly documents cGMP Quality Control testing.
Independently operates basic and moderately complex cGMP Quality Control equipment.
Assists in authoring technical documents such as SOPs, reports.
Performs self-review of analytical data for accuracy and consistency with SOP.
Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
Performs general lab housekeeping in adherence to 5S standards.
Initiates and assists with records in Trackwise.
Accurately completes routine and preventive maintenance on basic to moderately complex equipment.
Actively participates in team meetings and/or training sessions.
Other duties as assigned.

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
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 effective day one of employment
Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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