Scientist, QC Analytical
Company: Disability Solutions
Location: Severn
Posted on: September 28, 2024
Job Description:
The Scientist, QC Analytical is responsible for supporting
analytical testing in order to support GMP manufacturing for both
clinical and commercial clients. The Scientist, QC must demonstrate
technical knowledge, be familiar with basic scientific/regulatory
principles, possess initiative, and maintain a strong commitment to
scientific excellence.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 is
committed to a Patient First culture through excellence in quality
and compliance, and to the safety of every patient, consumer and
Catalent employee.Shift: Wednesday-Saturday 7am-6pmThe role:
- Perform assays such as ELISA, DNA/RNA extraction and gel
electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis,
Appearance, Osmo, and pH
- Documenting testing per GMP/GDP procedures
- Generate internal and external documents such as assay
protocols, summary reports, and SOPs
- Analytical support to QC method services of method verification
of platform test methods
- Supports release and stability testing for raw materials,
components, standards, intermediate/finished products
- Generate internal and external documents such as summary
reports, and SOPs
- Reviews laboratory work and approves data packages as
designated by the Supervisor
- Provide instrumentation care, maintenance, troubleshooting, and
data interpretation
- Responsible for document writing (laboratory investigations,
out of specifications, deviations, CAPAs), data
interpretation/presentation, statistical analysis, and trendingThe
candidate:
- Masters' in a Life Sciences discipline with 0 - 2 years of
experience working in a cGMP QC laboratory.
- Experience with any of the following techniques is preferred
ELISA, qPCR, ddCPR, HPLC,CE
- Knowledge/expertise relevant to QC analytical methods used for
protein chemistry and molecular biology
- Experience within the biologic, pharmaceutical, or medical
device industry performing direct hands-on work in QC function with
a strong familiarity of general GMP practices
- Experience in writing SOPsWhy you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
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, Severn , Scientist, QC Analytical, Other , Severn, Maryland
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