Scientist I - Quality Control, Data Review

Catalent Pharma Solutions • Madison, WI

1d • Onsite

About The Position

Scientist I - Quality Control, Data Review Position Summary: Work Schedule: M-F 8am-5pm 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 market 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, Data Review. This position requires a variety of skills necessary for biotech company operations. The basic purpose of the QC Reviewer is to assure the quality of laboratory data and reports. This is accomplished by reviewing chromatographic data and related notebooks as specified by Standard Operating Procedures. The objective of the QC review process is to evaluate chromatographic data to assure compliance with analytical methods, FDA's Good Laboratory Practices and/or Good Manufacturing Practices and client criteria.

Requirements

• M.S./M.A. in Biotechnology, or related field, with no prior experience; or B.S./B.A. in Biotechnology, or related field, with minimum of 3 years’ experience in related laboratory work; or Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years’ experience in related laboratory work
• Knowledge of chromatography, Standard Operating Procedures, and FDA regulations.
• > 3 years of QC experience; lab experience preferred
• Familiar with cGMP documentation practices.

Nice To Haves

• Preferred knowledge includes but is not limited to HPLC, SDS-PAGE, Western Blot, HPLC, cIEF and ELISA experience, and/or Microbiology testing.

Responsibilities

• Accurately review analytical and/or microbiological testing following SOPs.
• Reviews and verifies analytical and/or microbiological data and reports, ensuring accuracy and consistency.
• Provide clear feedback for corrections needed.
• Actively participates in team meetings.
• Other duties as assigned.
• All 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees