Specialist II, Inspection/Packaging
Company: Disability Solutions
Location: Bloomington
Posted on: October 12, 2024
Job Description:
Specialist II, Inspection and Packaging 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 facility in Bloomington provides a fully
integrated and unique model for process development, clinical and
commercial mammalian cell culture manufacturing, formulation,
parenteral drug manufacturing and packaging under one roof. The
award-winning facility provides clinical and commercial bulk drug
substance and drug product manufacturing, including liquid and
lyophilized vials, and prefilled syringes, along with an array of
support services.The Drug Product Support department is responsible
for supporting the Operations Team in the execution of clinical and
commercial manufacturing in accordance with regulatory, site, and
client requirements. This includes Primary and Secondary
Operations.---- Manufacturing cGMP production support activities
include audit preparation, audit performance, documentation and
metric tracking, documentation review, deviation identification and
authoring, Corrective Actions, Change Management, and process
improvements.--The Specialist II, Inspection and Packaging provides
direct technical support to operations area as it relates to
documentation, equipment procurement, testing, operational
excellence, and training. This role works collaboratively with
multiple company functions to ensure production systems operate in
a safe, and quality-oriented manner.This is a fulltime, onsite
role, working days; Monday - Friday.-- ----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
- Provide direct technical support for production processes and
implementation of improvements
- Ownership of Corrective Actions, Change Management, Audit
Support as SME, GMP and document revision, review and approval
- Lead and participate in continuous improvement process
changes
- Direct interaction with Client and Regulatory Auditors
- Completes assignments and facilitates the work activities of
others; may coordinate work beyond own area
- Works autonomously within established procedures and
practices
- Perform Investigations and Root Cause Analysis in Global
Trackwise quality system utilizing technical writing skills; Create
and assist in implementation of Corrective and Preventative Actions
(CAPAs)
- Other Tasks as AssignedThe Candidate
- High School/GED with 3+ years' pharmaceutical and/or
manufacturing experience required OR
- Associate degree with 2 years' pharmaceutical and/or
manufacturing experience required OR
- Bachelor's degree in a manufacturing field of study with 1+
year pharmaceutical and/or manufacturing experience preferred
- Audit and inspection experience preferredWhy You Should Join
Catalent
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
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 , Specialist II, Inspection/Packaging, Other , Bloomington, Indiana
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