Associate Scientist - QC
Company: Disability Solutions
Location: Bloomington
Posted on: October 24, 2024
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Job Description:
Associate Scientist - QCPosition Summary--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 in Bloomington, Indiana is a
state-of-the art, GMP manufacturing facility, providing one million
sq/ft of drug substance manufacturing, drug product manufacturing,
and related pharmaceutical services. This award-winning facility
helps customers accelerate biologic drug development programs and
bring better treatments to help patients live better, healthier
lives.-----The Associate Scientist - QC will perform routine
testing of process samples, raw materials, finished products and
stability samples, while adhering to SOPs and working in a cGMP
compliant environment.This position is Friday-Monday 6PM-6AM
Weekend PM shift and 100% on site at our Bloomington, Indiana
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:------- --Carries
out Microbiology testing such as, microbial enumeration testing and
endotoxin testing, data analysis, document writing, and data
reporting to support the manufacturing and release of bulk drug
substance and drug product.------- --Evaluates the effectiveness of
microbial controls necessary to ensure that the manufacturing
facility is maintained in a manner that prevents the ingress of
microorganisms in low bioburden products by performing routine and
investigational sampling of the manufacturing environment and
associated facilities.------- --Independently executes and properly
documents cGMP Quality Control testing; independently operates
basic and moderately complex cGMP Quality Control equipment.-------
--Assists in authoring technical documents such as SOPs and
reports; coordinates with Supervisor to prioritize and schedule
activities to meet deadlines.------- --Supports continuous process
improvement initiatives; enters data into Laboratory Information
Management System (LIMS) or laboratory reports; accurately
completes routine and preventive maintenance on basic to moderately
complex equipment.------- --Other duties as assignedThe
Candidate:------- --Bachelor in a science field required with
experience working in a cGMP QC laboratory preferred.---------
--General laboratory equipment experience, including micropipettes
required------- --Preferred: Basic understanding of analytical
chemistry and simple lab equipment; familiarity with clean room
procedure, aseptic technique, and general lab equipment experience;
cGMP, Good Documentation Practices (GDP), or Good Laboratory
Practices (GLP) knowledge.------- --Ability to maintain batch
records and/or laboratory notebook and complete all laboratory
documentation in clear and accurate language and according to SOP;
ability to attend training and apply learning on routine operation,
maintenance, and theory or laboratory instrumentation, SOPs, and
regulatory guidelines; ability to use Excel, Word, and other Office
systems.------- --Ability to add, subtract, multiply, divide and to
record, balance, and check results for accuracy; ability to peer
review data to ensure data is well organized with complete
documentation; ability to understand and independently apply GMPs
to everyday work with regard to documentation and instrument use;
ability to apply applicable regulatory authority and guidelines
with training.------- --Ability to maintain lab equipment; ability
to operate within a clean room environment as needed; Accountable
for owning, reviewing and approving documentation such as
procedures, method and protocols; accountable of owning laboratory
investigations, within the quality systems------- --Must be able to
read and understand English-written job instructions and safety
requirements.------- --Environmental requirements: Frequent
sitting, standing, walking, reading of written documents and use of
computer monitor screen, reaching with hands and arms, talking,
writing, listening; occasional stooping, kneeling, crouching,
bending, carrying, grasping; frequent lifting and/or moving up to
10 pounds and occasional lifting and/or moving up to 50 pounds;
Working in a lab environment will require working with skin
irritants, lung irritants, electrical equipment, sharp instruments,
toxic materials, and hazardous waste. Safety procedures will be
followed to minimize exposure, including clean room gowning.Why 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
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.--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, Bloomington , Associate Scientist - QC, Other , Bloomington, Indiana
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