Senior Scientist I - Quality Control (Data Review)
Company: Disability Solutions
Location: Madison
Posted on: October 19, 2024
Job Description:
Senior Scientist I - Quality Control (Data Review)Catalent is a
global, high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--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 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.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 review of 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. Other duties will include data review/archiving, database
entry/review and contributions to process improvement
initiatives.This is a full-time on-site salaried position, Monday -
Friday, 9:00am - 5:30pmCatalent is committed to a Patient First
culture through excellence in quality and--compliance, and to the
safety of every patient, consumer, and Catalent employee.--The
Role: --
- Independently reviews executed cGMP Quality Control
testing
- Coordinates with Supervisor to prioritize and schedule
activities to meet deadlines
- Supports continuous process improvement initiatives
- Interacts as an SME for internal and external customers
- Supports training of specific analytical techniques
- Reviews data present in Laboratory Information Management
System (LIMS) or laboratory reports
- Actively participates in team meetings and/or training
sessions
- Other duties as assignedThe Candidate:
- Must have Ph.D. Degree in Biology, Biotechnology, Chemistry or
related life sciences field OR
- Master's Degree in Biology, Biotechnology, Chemistry or related
life sciences field with a minimum of 4 years of industry
experience OR
- Bachelor's Degree in Biology, Biotechnology, Chemistry or
related life sciences field with a minimum of 6 years of industry
experience OR
- Associate's Degree in Biology, Biotechnology, Chemistry or
related life sciences field with a minimum of 10 years of industry
experience OR
- High School Diploma or equivalent with a minimum of 11 years of
industry experience
- Experience using Empower Software is preferred
- Experience writing technical documents is preferred
- Experience following standard operating procedures (SOP) is
preferredWhy you should join Catalent:
- 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 paid time off annually +--8--paid holidays--
- Competitive salary with yearly bonus potential--
- Community engagement and green initiatives--
- Generous 401K match and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment
- Tuition ReimbursementCatalent 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 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 . 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 .
Keywords: Disability Solutions, Dubuque , Senior Scientist I - Quality Control (Data Review), Other , Madison, Iowa
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