Quality Assurance Associate, Analytical
Company: Disability Solutions
Location: San Diego
Posted on: May 4, 2024
Job Description:
Job Title:----Quality Assurance Associate, AnalyticalCity:-- San
DiegoState:----CAJOB DESCRIPTION:
- Review of analytical release and stability data, involving
review of Potency tests of investigational new tablets and capsules
using High Performance Liquid Chromatography (HPLC) or Ultra
Performance Liquid Chromatography, Water Content using Karl Fischer
Titration and Karl Fischer Oven, physical characterization of
crystalline and partially crystalline solids using tests like
Powder X-Ray Diffraction (PXRD), Thermogravimetric analyzer (TGA)
and Differential Scanning Calorimeter (DSC). Review Hardness
testing and Friability of tablets, Content Uniformity and Blend
Uniformity using HPLC, Dissolution of tablets and capsules using
UPLC or UV-Vis Spectroscopy, testing for Residual Solvents using
Gas Chromatography (GC) and Microbial Enumeration Testing (MET) of
samples using Empower 3 for HPLC and UPLC, Tiamo for the Karl
Fischer Oven, Miniflex Guidance for PXRD, and the Trios Guardian
Software for TGA and DSC.
- Review and approve controlled documents including protocols,
test methods, master batch records, and specifications for
analytical testing.
- Lead role in onboarding new compounds to the site involving
review of toxicology data and performing a nitrosamine assessment
to ensure the risks of a new compound are considered against site
capabilities.
- Perform internal and external audits.
- Lead or support client audits along with the Director and
Associate Director of Quality Assurance
- Manage a direct report and train the direct report on
analytical data review of stability and release data.
- Perform Line Clearance activities to ensure the correct
equipment and materials have been staged in the manufacturing suite
before the production begins.
- Perform the release, quarantine and rejection of raw materials
used in the production of samples and approve the respective
specification of raw materials.
- Review calibration, validation and preventative maintenance
certificates of laboratory and manufacturing equipment.
- Point person for safety complaints and improvements in the
Quality Assurance Department using the Intelex software for logging
complaints.EDUCATION AND EXPERIENCE: Requires a Bachelor's degree
in Biotechnology or Related Field and 2 years of experience in job
offered or 2 years of experience in the Related Occupation
--RELATED OCCUPATION: Quality Assurance Associate or any other job
title performing the following job duties:
- Reviewing of analytical release and stability data, involving
review of Potency tests of investigational new tablets and capsules
using High Performance Liquid Chromatography (HPLC) or Ultra
Performance Liquid Chromatography, Water Content using Karl Fischer
Titration and Karl Fischer Oven, physical characterization of
crystalline and partially crystalline solids using tests like
Powder X-Ray Diffraction (PXRD), Thermogravimetric analyzer (TGA)
and Differential Scanning Calorimeter (DSC). Review Hardness
testing and Friability of tablets, Content Uniformity and Blend
Uniformity using HPLC, Dissolution of tablets and capsules using
UPLC or UV-Vis Spectroscopy, testing for Residual Solvents using
Gas Chromatography (GC) and Microbial Enumeration Testing (MET) of
samples using Empower 3 for HPLC and UPLC, Tiamo for the Karl
Fischer Oven, Miniflex Guidance for PXRD, and the Trios Guardian
Software for TGA and DSC.
- Reviewing and approving method validation reports for
analytical testing.
- Performing internal and external audits.
- Training new hires on analytical review of stability
data.SALARY RANGE: $128,128 to $130,000/yearJOB TIME:---- Full
TimeCatalent 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.--Catalent is committed to the health and
safety of its employees, visitors and the customers and patients we
serve. As a result of the global pandemic, we have modified many of
our recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------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, National City , Quality Assurance Associate, Analytical, Other , San Diego, California
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