Associate, Quality Assurance
Company: Disability Solutions
Location: Kansas City
Posted on: October 11, 2024
Job Description:
Associate, Quality AssurancePosition 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's Kansas City facility is home to our Oral &
Specialty Drug Delivery, Biologics Analytical Services and Clinical
Supply Services businesses. The site provides a range of integrated
services for oral solid dosage forms, from formulation development
and analytical testing to clinical and commercial-scale
manufacturing.-- The Kansas City facility is a Center-of-Excellence
for our Biologics Analytical Services business. Our talented team
has over 25 years of experience providing analytical services for
stand-alone and integrated biologics projects.The Associate,
Quality Assurance (QA) is responsible for quality oversight of
manufacturing "floor" activities and the associated in-process GMP
(Good Manufacturing Practices) records. In addition to day-to-day
responsibilities, the QA Associate will identify and participate in
opportunities to improve processes.This is a full-time hourly
position: Monday-Friday: 1st shift with hours between 6am-2:30pm.
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: --
- Responsible for oversight of the Quality support functions
associated with the manufacturing of products
- Performs batch record review, cleaning log review, and complete
monthly and daily facility audits
- Ensures with a clear understanding that products are
manufactured according to applicable cGMPs, FDA (Food and Drug
Administration) guidelines, MHRA (Medicines and Healthcare products
Regulatory Agency) guidelines, regulations GXPs and internal SOPs
(Standard Operating Procedures) as necessary to accomplish daily
tasks
- Identify deviations during manufacturing and provide direction
as to the appropriate course of action
- Review and approve batch documentation to adherence to SOPs and
cGMPs
- Participates in QA programs, procedures and controls to ensure
that products conform to established standards and agency
guidelines
- Assist with manufacturing floor activities (equipment/room
approval, facility compliance)
- Other duties as assignedThe Candidate: --
- High school diploma required with 3+ years
Manufacturing/Quality Assurance experience in a GMP manufacturing
environment. Will also accept Bachelor's degree in a life science
or business-related field with no experience.
- Must have experience with batch record review, floor QA,
reviewing of equipment logs and documents, room approvals/line
clearances, preferably in a pharmaceutical or regulated
industry.
- Must have ability to follow a variety of instructions furnished
in written, oral, diagram, or schedule form
- Must have sufficient skills and knowledge in the use of
computers and associated computer technology.-- Computer technology
relates to both the hardware and software used in performing common
computing tasks. (Word, Excel, Outlook, PowerPoint basics)
- 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 50 pounds. Specific
vision requirements including reading of written documents, visual
inspection of materials and use of computer monitor screen
frequently. May require the use of a respirator.Why you should join
Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- Positive working environment focusing on continually improving
processes to remain innovative
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives--
- Generous 401K match--
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
start a new degree!
- 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, Olathe , Associate, Quality Assurance, Other , Kansas City, Kansas
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