Quality Assurance Associate, Analytical
Company: Disability Solutions
Location: San Diego
Posted on: April 19, 2024
Job Description:
Quality Assurance Associate, Analytical Position
Summary:Catalent Pharma Solutions in San Diego, CA is hiring a
Quality Assurance (QA) Associate, Analytical. The QA Associate must
be familiar with applicable GMP. This individual will be
responsible for evaluating the compliance of manufacturing and
analytical documents such as test methods, batch records, stability
and release data, etc. with supervision. This individual will
function as a primary role within the QA department and must
demonstrate excellent communication, critical thinking, and
organizational skills.This is a full-time position: Monday -
Friday, 8am-5pm on-site.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
Pharma Solutions in San Diego is a premier pharmaceutical chemistry
development and manufacturing organization supporting the
pharmaceutical and biotechnology industries. We focus on bringing
client drug compounds from discovery to the clinic with services
that include analytical development, pre-formulation testing,
formulation development, GMP manufacturing and stability storage
and testing as well as Clinical Supply Services.-- At Catalent San
Diego, we recruit and develop exceptional individuals with a
passion for science and determination to excel. We offer a
technically challenging and stimulating environment and the
opportunity to learn from the best. 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.--The Role:
- 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.
- Other duties as assigned.The Candidate:
- Requires a Bachelor's degree in Biotechnology (or related
field) plus a minimum of 2 years of experience in a related
occupation.
- Related occupation experience is: 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.
- Must have experience with reviewing and approving method
validation reports for analytical testing, performing internal and
external audits, and training new hires on analytical review of
stability data.
- Demonstrable leadership experience at Catalent (including but
not limited to participation in Catalent-sponsored leadership
programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may
be considered in place of external experience.
- Physical Requirements: On an average 8-hour day this position
requires the ability to walk, sit and stand, use hands to handle or
feel, reach with hands and arms at or above shoulder height and
below waist height, climb or balance, stoop, kneel, crouch, or
crawl; talk and hear, smell and lift up to 25 pounds. Specific
vision requirements including reading of written documents, visual
inspection of materials and use of computer monitor screen
frequently.Pay:
- The anticipated salary range for this role in San Diego, CA is
$128,128 - $130,000 annually. The final salary offered to a
successful candidate may vary, and will be dependent on several
factors that may include but are not limited to: the type and
length of experience within the job, type and length of experience
within the industry, skillset, education, business needs, etc.--
Catalent is a multi-state employer, and this salary range may not
reflect positions that work in other states.Why you should join
Catalent:
- Awesome employee activities:-- Movie Day, Monthly Birthday
Celebrations, Friday Bagel Breakfast, On-site Fitness Center with
machines, on-site yoga and HIIT classes, Sponsored Sports Teams,
and several other company-sponsored events that encourages positive
employee comradery, which contributes to effectively building
positive employee relationships, overall creating a positive work
environment.
- Environmentally friendly green initiatives with on-site
practices as well as regularly participating in Beach Clean-up
activities for community engagement.
- Defined career path and annual performance review and feedback
process. Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives. --
- Several Employee Resource Groups focusing on Diversity and
Inclusion.
- Competitive salary with bonus potential. Generous 401K
match--and Paid Time Off accrual. Medical, dental and vision
benefits effective day one of employment.--
- 152 hours of PTO + 10 paid holidays.
- Positive and fast-paced working environment focusing on
continually improving processes to remain innovative and
dynamic.
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- GymPass program to promote overall physical wellness.
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categories.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.--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, Escondido , Quality Assurance Associate, Analytical, Other , San Diego, California
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