QC Scientist
Company: Disability Solutions
Location: Severn
Posted on: October 12, 2024
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Job Description:
Scientist, QC Microbiology - MarylandPosition SummaryCatalent 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's Harmans/BWI, MD facility is a FDA-licensed,
state-of-the-art CGMP manufacturing facility for Gene Therapies.
The campus features two manufacturing facilities: The Harmans/BWI-1
EMA and FDA approved facility, at approximately 200,000 sq. ft.,
houses 10 CGMP manufacturing suites, fill/finish, central services,
testing labs, and a warehouse. The Harmans/BWI-2 facility, at
approximately 145,000 sq. ft., is under development and will house
8 CGMP manufacturing suites and cold storage warehousing. Both
facilities support Phase 3 through commercial manufacturing of
advanced therapeutic products including AAV and other viral
vector-based therapies and vaccines.The Scientist, QC Microbiology
will assist with the end-to-end contamination control and sterility
assurance practices for Catalent's aseptic production process. This
position will support the following areas: Aseptic processing,
cleaning and disinfection process, microbiological testing,
environmental control and monitoring, and compliance to regulations
and standards in the subject of sterility assurance and
contamination control. The Scientist will work both independently
and with the team to perform routine and non-routine
microbiological testing, environmental monitoring, and/or and
microbiology laboratory maintenance functions, where
necessary.--This position is 4th shift Friday through Monday
8:30am-6:30pm and 100% on site at Harmans/BWI, MD
facility.--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:----- Ensure
testing compliance meets the requirements of ISO, USP, EU, CFR,
cGMP, and GLP, in the Microbiology laboratory at all times;
document laboratory test results utilizing Good Documentation
Practices; conduct sampling and testing of utilities such as USP,
WFI water, clean steam, and CCA/Gas.----- Maintain the Micro labs
in a state of audit readiness; maintain a working knowledge of all
Micro laboratory instrumentation used for testing and EM
procedures; provide accurate product, raw material, and
Environmental monitoring data----- Perform peer review for Micro
results and media plate reads for other Microbiologists, ensuring
current results and reports meet SOP and protocol
requirements.----- Perform Bacterial Endotoxin testing using the
kinetic chromogenic method; perform routine and in-process
environmental monitoring in Grades A, B, C, and D environments,
including areas where full aseptic gowning is worn for extended
periods of time.----- Perform growth promotion testing of
microbiological media; perform microbial isolation techniques,
subculturing, and Gram stain identifications; --perform bioburden
testing using membrane filtration for cleaning, in-process,
buffer/media, and release samples.----- Support continuous
improvement projects related to QC; assist with input for revision
and creation of controlled documents such as Standard Operating
Procedures and controlled forms. Author non-routine
protocols/validation plans/reports in support of projects; assist
with investigations, change controls, and CAPAs associated with
microbiological testing; may assist QC Manager/Supervisor with GMP
and safety training of Quality Control staff.----- Perform general
laboratory cleaning/wipe-down; perform routine maintenance of lab
equipment and maintain lab inventory.----- Support data trending
and tracking of results; provide training to all Microbiologists on
new and existing revisions to laboratory methods and work
instructions; actively participate in training activities and
managing individual training plan; communicate effectively with QC
peers, cross-functional peers, and management.----- Other duties as
assigned.--The Candidate:--------- --Bachelor in a Microbiology,
Biology, or related discipline with 2+ years of experience working
in a cGMP QC laboratory OR Masters in a Microbiology, Biology, or
related discipline with experience working in a cGMP QC laboratory
preferred.------- --Experience working in cGMP Quality Control;
experience in cGMP environment and experience with Quality Tools
such as SPC and Root Cause Analysis, FMEA, HACCP, and technical
writing skills.--------- --Test method development and validation
of various bioassay and microbiological or chemical test attributes
experience; demonstrate strong scientific understanding of
microbiological methods; strong knowledge of microbiological method
design.--------- --Comfortable working in cleanroom and BSC
environments in aseptic gowning for extended periods of time;
demonstrated ability to investigate and identify causes of suspect
laboratory results.--------- --Strong technical writing skills and
use of Microsoft Office products.--------- --Strong attention to
detail and strong organizational skills; strong verbal
communication skills with internal teams and outside contract
laboratories; ability to succeed in a team-oriented environment
under very dynamic conditions.--------- --Must have the ability to
work an available set shift. There will be times when overtime is
required.--The anticipated salary range for this position in
Maryland is $73,080-101,680 plus shift differential and annual
bonus, when eligible. --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 statesWhy you should join
Catalent:------- --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--------- --Dynamic, fast-paced work
environment------- --Generous 401K match and Paid Time Off
accrual--------- --Medical, dental and vision benefits effective
day one of employment--------- --Tuition Reimbursement---------
--Wellhub program to promote overall physical wellness---------
--Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
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, Alexandria , QC Scientist, Other , Severn, Virginia
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