QA Inspector- 2nd Shift
Company: Disability Solutions
Location: Philadelphia
Posted on: May 3, 2024
Job Description:
QA InspectorPosition SummaryCatalent Pharma Solutions in
Philadelphia, PA is hiring a QA Inspector.-- This position reports
to the Quality Supervisor. 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 implementation and improvement,
in partnership with Production personnel.This is a full-time role
position: Monday - Friday, 2nd shift, 3:45pm-12:15am.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.--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 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.----
- Reviews and understands both the Production Protocol and QA
Protocol prior to starting the packaging process. Performs and
documents hourly QA Inspections on assigned packaging rooms as per
both the QA Protocol and SOP requirements.
- Ensures that the Production (Packaging) Protocol and GMP
standards are being followed during the packaging process.--
- Reviews the batch record and any associated paperwork for any
documentation errors made during the packaging operation and again
when the job is completed prior to submitting the batch record for
final review and release.
- Prints and reviews Material Usage Reports for packaging job(s)
and/or operation(s) to ensure that the drug product quantities
documented in the batch record match those that are entered in the
Inventory Management System.
- Other duties as assigned.The Candidate
- Highschool diploma or general education diploma is
required.
- College degree preferred (BA, BS) or at least 3 years of
Production/Quality Assurance experience is preferred. College
seniors graduating within 4 months are also eligible for this
role.
- Proven track record of monitoring/auditing for quality
assurance and/or identifying potential efficiencies in a production
environment is preferred.
- Ability to quickly learn and implement QA Auditing
techniques.
- Experience in a regulated field preferred - Pharma or
Food.
- Good communication skills, both written and verbal.
- Strong interpersonal skills and is comfortable working in a
team environment.
- Good Computer skills.-- Knowledge of MS Office and Inventory
Management system are a plus.
- Knowledge of the application of FDA cGMP's.
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds.-- Individual must be accessible to
production floor, supply chain and office staff and to use required
office equipment.-- Specific vision requirements include reading of
written documents and use of computer monitor screen frequently.Why
you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 152 hours of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- 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--
- Competitive salary with possible bonus potential--
- Community engagement and green initiatives--
- Generous 401K match--and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- GymPass 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.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------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, Camden , QA Inspector- 2nd Shift, Other , Philadelphia, New Jersey
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