Senior Associate, Quality Control Associate - Data Review

Catalent Madison , WI 53706

Posted 2 months ago

Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Position Summary

Due to growth, Catalent Pharma Solutions is currently hiring for a Senior Associate, Quality Control Associate

  • Data Review for our Quality Control department at the Madison, WI biologics site.

The Senior Associate, Quality Control Associate

  • Data Review will 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 Senior Associate, Quality Control Associate

  • Data Review will assure compliance with analytical methods, FDA's Good Laboratory Practices, Good Manufacturing Practices, and client criteria.

The Senior Associate, Quality Control Associate

  • Data Review role contributes to the patient first philosophy by ensuring quality of data and that all data generated is consistent with expectations. The Senior Associate, Quality Control Associate

  • Data Review position is critical to the patient first philosophy because it confirms tests were executed according to the defined procedures and results are within the required specifications.

The Role

  • Accurately reviews analytical and/or microbiological testing following SOPs.

  • Reviews and verifies analytical and/or microbiological data and reports, ensuring accuracy and consistency.

  • Provides clear feedback for corrections needed.

  • Familiar with cGMP documentation practices.

The Candidate

  • B.S./B.A. in Biotechnology, or related field, with minimum of 3 years' experience in related QA/QC position.

  • Knowledge of chromatography, Standard Operating Procedures, and FDA regulations.

  • One year of QC experience; lab experience preferred.

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

Catalent's standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • Fast tracked career growth, with annual performance review and feedback process

  • Competitive base salary with other compensation incentives including yearly incentive plan

  • Medical, Dental, Vision, and 401K are all offered on day one of employment

  • 19 days of Paid Time Off (PTO) + 7 paid holidays

  • Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!

  • Defined career path and annual performance review and feedback process

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 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, 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.


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Senior Associate, Quality Control Associate - Data Review

Catalent