Quality Assurance Inspector
Company: Catalent Pharma Solutions
Posted on: April 11, 2021
Catalent hires people with a passion to make a difference to the
health of millions of people globally. Your expertise, coupled with
Catalent's advanced technologies and collaboration with thousands
of innovative pharmaceutical, biotech and healthcare companies,
will help bring life-enhancing products to the people you know and
love. Your talents, ideas and passion are essential to our mission;
to develop, manufacture and supply products that help people live
better, healthier lives. Interested in learning more about life at
Catalent? Start here Job Title Position Summary The Quality
Inspector is responsible for performing inspection and release of
all components, clinical trial and commercial labels, drug
products, distribution materials and paperwork as well as materials
slated for destruction and associated paperwork, while ensuring
SOPs and cGMP are being followed. The Quality Inspector role is
critical to our patients. Ensuring product quality, and identifying
opportunities to improve the processes, with patient safety in
mind, executing with efficiency always. Quality, safety and on-time
delivery is a must to be successful in this role!-- The Role (daily
- Responsible for ensuring that Standard Operating Procedures are
consistently followed and that cGMP's are observed, in the course
of incoming inspection, distribution, label control, destruction
and returns. This may require the simultaneous auditing and/or
monitoring of one or more processes.
- Verifies and inspects incoming materials and works accordingly
with Quality and Project Management to handle any possible
- Perform inspection and release of all clinical and commercial
drug product and components received from customer or vendor as per
customer specifications protocols and/or Catalent SOPs, includes
review of all inventory labels applied to the containers and
paperwork generated from JDE with receipt paperwork.
- Perform inspection and release of all shipping and distribution
materials to clinical sites or clients by reviewing all associated
paperwork and picked material, including verification of each
individual randomized container and compliance with customer
specific distribution protocols.
- Perform inspection and release of materials slated for
destruction, by reviewing the associated paperwork and picked
- Inspect and release of clinical open, randomized, single panel
booklet and multi language labels produced by external vendors and
Clinical Supply Services by comparison to approved label proof or
label copy request.
- Reviews BMS system printouts and chart recorder printouts for
out of specification temperatures, humidity and pressures.
- Inspect retain samples, as required
- Assists in walk through audits of the Logistics facility, Label
control room, Refrigerator/Freezer and associated areas to ensure
cGMPs and SOPs are being followed.
- Reviews Logistics Facility logbooks, Label Room logbooks, Pest
Control logbooks and Sampling Room logbooks for GMP compliance and
revises SOPs as needed.
- Partners with other departments in resolving unplanned
deviations, investigations, in troubleshooting, and in process
- Performs additional sampling/testing protocols on clinical
trial materials as requested by the customer.
- Participates in customer audits when required.
- Performs other duties or tasks as requested or required by QA
Management. The Candidate (requirements)
- Minimum of a High School Diploma with 2+ years in
- Bachelor's Degree Preferred. Will consider Bachelor's Degree
with 0-2+ years' experience.
- Good Communication Skills, both written and verbal.
- Strong interpersonal skills and is comfortable working in a
team environment, as well as independently.
- Good Computer Skills. Knowledge of MS Office and Inventory
Management system are a plus.--
- Good knowledge of the application of FDA cGMP's .
- Exercise sound judgment and is analytical in thought.
- Is comfortable working in a dynamic environment with many
- Ability to be on feet and move easily throughout the Logistics
- Ability to quickly learn and implement QA Auditing techniques.
Catalent's standard leadership competencies that are used to
interview and for Performance & Development:
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Competitive benefits and 401K plan
- Opportunities for growth
- 19 days of PTO 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. 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. C atalent is an Equal Opportunity /
Affirmative Action employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, disability, protected veteran
status, sexual orientation or gender identity. 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
DisabilityAccommodations@catalent.com . 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.
Full time 0052952 About Us Catalent = Catalyst + Talent Your
talents, ideas, and passion are essential to our mission: to
develop, manufacture, and supply products that help people live
better, healthier lives. Join us! personal initiative. dynamic
pace. meaningful work. Catalent is the perfect place to grow your
- You enjoy the fast pace of a start-up, but want the
opportunities and stability of a growing, publicly traded company
(Listed on NYSE: CTLT).
- You want meaningful work. From cough treatments to
cancer-fighting drugs, biologics, and vitamins, we help develop,
launch, and supply over 200 new products each year - more than any
branded drug maker in the world!
- You want to plant your career in a growing company. Over the
last five years, Catalent has re-invested more than $2 billion back
into the company and its people.
- You are excited about learning, collaborating, and growing
alongside a global diverse team. Our team of more than 11,000 comes
to work every day ready to overcome new challenges with teamwork,
advanced technologies, and a passion to deliver by putting patients
- You want to make a global impact! From North America to Europe,
Asia to Latin America, we have innovative science and manufacturing
teams who are looking for YOU!
- See how our teams are making a difference, while growing their
careers and fulfilling our mission by putting patients first every
day here .--
Keywords: Catalent Pharma Solutions, Philadelphia , Quality Assurance Inspector, Professions , Philadelphia, Pennsylvania
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