Quality Assurance Inspector
Company: Disability Solutions
Location: Philadelphia
Posted on: November 4, 2024
Job Description:
Quality Assurance InspectorPosition Summary: Catalent is a
global, high-growth, private 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.----This 206,878 square-foot facility, located in the
Philadelphia area is Catalent's global Center of Excellence for
Clinical Supply Packaging.-- Catalent offers GMP secondary
packaging and clinical labeling services throughout our global
network. Packaging can be configured to hold a single product, or
multiple products as determined by study requirements. We offer
manual patient kit assembly along with semi-automated and automated
wallet sealing and high-speed automated carding to meet the needs
of studies of all sizes. For temperature sensitive products and
those with minimal to zero allowable time out of environment, we
can perform secondary packaging in refrigerated and frozen
packaging rooms or over dry ice depending upon your project
needs.-- Using our Clinicopia global labeling system with its
multi-lingual label phrase library we can design single panel,
booklet labels or our unique Peel-ID--- safe storage labels for
your studies. Single panel and Peel-ID--- safe storage labels can
be conveniently reviewed and approved online via our Fusion portal
before being printed and inspected at our facilities.Catalent
Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance
Inspector.-- The Quality Assurance Inspector reports to the Quality
Assurance Supervisor, Production. The Quality Inspector is
responsible for process monitoring and auditing of packaging
operations, the duties including real-time batch documentation
review, monitoring of adherence to cGMP, training on cGMP where
necessary, and supporting actions (if required) for resolution of
deviations and investigations. The scope of work will cover
packaging room and equipment set up, equipment verification,
routine packaging operations, line clearances, room and equipment
cleaning activities. The Quality Inspector will identify
opportunities to improve the 'right-first time' performance of the
operation and will manage those opportunities to implement and
improve, in partnership with Production personnel.This is a
full-time, hourly role. ----This is onsite.-- This position is a
1st shift role. The hours are Monday - Friday,
7:45am-4:15pm.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 ensuring that Standard Operating Procedures are
consistently followed, and that cGMP's are observed, in the course
of packaging operations; This may require the simultaneous auditing
and/or monitoring of one or more operations
- Verifies and/or reconciles materials to and from production
rooms and works accordingly with Production, Materials Management
and Project Management to handle any possible discrepancies
- Inspects and releases all packaging rooms to ensure that they
have been properly cleaned and that all materials have been
removed
- Documents activities accordingly in the associated logbook(s);
Reviews production logbooks for GMP compliance
- Supports and assists Mechanics on the execution of Operational
Verifications (OVs) and Set-Up records both prior to the start and
during the packaging process (if necessary) for any jobs using
packaging machinery
- Updates the daily/shift QA turnover log with all pertinent
information regarding activities during the assigned rooms and
shifts and forwards relevant notes to all pertinent employees
- Performs walk through audits of the production floor, clean
storage rooms, warehouse and associated areas to ensure cGMPs are
being followed
- All other duties as assignedThe Candidate:
- Bachelor degree is required
- At least three years of experience in Production or Quality
Assurance is preferred
- A demonstrated history of effectively monitoring or auditing
for quality assurance, as well as recognizing possible efficiencies
within a production setting, is preferred
- Good computer skills; Knowledge of MS Office and Inventory
Management system are a plus
- Basic knowledge of Lean Six Sigma methodologies an
advantage
- Good knowledge of the application of FDA cGMP's
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 poundsWhy 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 of PTO + 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, Lancaster , Quality Assurance Inspector, Other , Philadelphia, Pennsylvania
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