Quality Assurance Document Control
Company: Disability Solutions
Location: Philadelphia
Posted on: April 19, 2024
Job Description:
Job DescriptionQuality Assurance Document ControlPosition
Summary:Catalent Pharma Solutions is Philadelphia, PA is hiring for
a Quality Assurance Document Control.-- The Quality Assurance
Document Control individual is responsible in preparing customer
files, review and approve batch records, and release batch records
and finished product.-- The Quality Assurance Document Control
individual acts as the primary liaison to our customer's quality
assurance groups for batch record review and release.-- The Quality
Assurance Document Control manages the communication between the
operations/production, project management, shipping and quality
assurance groups to ascertain pertinent information relating to the
contract packaging orders.--This is a full-time role position:
Monday - Friday, 7:30am-4:00pm.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
- Review and approve all batch records prior to production to
ensure that they conform to requirements of cGMP and Clinical Trial
Protocol.
- Includes review of material status, protocol conformance,
clinical design layout, ensuring blinding techniques are
followed.
- Primary liaison with client for batch release.
- Communicate with other functions to resolve inconsistencies
with proper recording and completion of the batch record and
associated documentation.-- Communications may include educating
other functions to ensure compliance to regulations, procedures and
client requirements.
- Ensure timely release of batch for protocol initiation
date.
- Release batch within scheduling database.
- Communicates SQDC countermeasures and safety issues to Quality
Management.
- Ensures QADC metrics are met or acts to correct.The Candidate
- BA/BS Degree OR Minimum of a High School Diploma with relevant
industry experience.
- Prior GMP experience strongly preferred.
- Experience with inspections or Batch Record Review a plus.
- Good organizational/time management skills and ability to
multi-task.
- Challenges status quo and initiates improvements.
- Good communication and math skills.
- Advanced computer skills - including a high level of
proficiency in Microsoft Office including Excel, Work, Outlook, IE,
SAP/JDEWhy you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 19 days of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Employee Stock Purchase Program
- 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, Lower Merion , Quality Assurance Document Control, Other , Philadelphia, Pennsylvania
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