Specialist, QA Raw Materials
Company: Disability Solutions
Location: Severn
Posted on: October 26, 2024
Job Description:
Specialist, QA - Raw MaterialsPosition SummaryCatalent 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 Harmans/BWI, MD facility is a FDA-licensed,
state-of-the-art CGMP manufacturing facility for Gene Therapies.
The campus features two manufacturing facilities: The Harmans/BWI-1
EMA and FDA approved facility, at approximately 200,000 sq. ft.,
houses 10 CGMP manufacturing suites, fill/finish, central services,
testing labs, and a warehouse. The Harmans/BWI-2 facility, at
approximately 145,000 sq. ft., is under development and will house
8 CGMP manufacturing suites and cold storage warehousing. Both
facilities support Phase 3 through commercial manufacturing of
advanced therapeutic products including AAV and other viral
vector-based therapies and vaccines.The Specialist, QA - Raw
Materials is responsible for ensuring the quality of incoming
materials and components meet quality expectations needed to assure
patient safety. --Providing QA support for GMP Raw Materials that
support the production of GMP Manufacturing operations.
--Responsibilities include providing QA oversight of materials used
for Manufacturing, Quality Control, and Process & Analytical
Development.--This position is 1st shift Monday-Friday 8AM-5PM and
100% on site at our Harmans/BWI, MD facility.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:
- Conducts critical reviews of GMP documentation associated with
materials control (material specifications, receipt inspection
forms, inventory records, item request form) by exercising
judgement within defined procedures and regulations.
- Continuously monitor systems and procedures to ensure
compliance with applicable regulatory and industry standards,
quality improvements, and efficiency for phase appropriate GMP
manufacture of biological products; creates raw material
specifications according to template requirements and information
provided by technical groups; adjust the materials specification
templates as needed to assure compliance with regulations and
client expectations.--
- Routes specifications for review and approval through workflow
in the Catalent EDMS. --Reviews, edits and revise Raw Material
specifications as indicated; edits raw materials specifications as
needed for client requests or supplier change notifications;
creates change controls and represent QA-RM team at Change Control
review board as needed; assists with the generation and/or revision
of GMP documentation such as Standard Operating Procedures as it
pertains to the disposition of Raw Materials
- Supports regulatory and client audit/inspections and supports
internal audits of GMP systems and facilities
- Engages with technical teams and Supply Chain as necessary to
proactively collect documentation for pending specifications; works
with Materials Control to quarantine and disposition all GMP
materials in a timely manner; works cross-functionally with
Materials Control, Purchasing, Manufacturing, Quality Control and
other departments to resolve raw material quality issues and
provide assistance when needed
- Continually evaluates Quality and Materials Control processes
and procedures to improve efficiency and ensure compliance to
appropriate GMPs; reviews and approves Deviations/Change
Controls/CAPAs and performs Acceptable Quality Limit (AQL) visual
inspection materials, as needed
- Actively participates in training activities, managing their
individual training plan.
- --Other duties as assigned.The Candidate:
- Masters' degree in a Scientific or Life Science discipline with
experience biologic, biopharmaceutical, or regulated industry
preferred OR Bachelors' degree in a Scientific or Life Science
discipline required with 2+ years' experience biologic,
biopharmaceutical, or regulated industry.--
- Manufacturing/Quality Assurance/Quality Control function
experience preferred; Raw Materials experience is a plus
- Experience with Good Manufacturing Practices (GMPs) and 21 CFR
part 11, a plus; experience using an EDMS and ability to create
workflows and reports from these systems--
- Hands on experience with an EDMS creating documents for a GMP
environment and the ability to create workflows and reports from
these systems, a plus.--
- Expert in formatting in Microsoft Word and use of edit
tools.--
- Good communication skills and ability to work in a group
setting where priorities may be shifted weekly; ability to work in
a cross functional team and escalate concerns related to priorities
and patient first concepts; offers suggestions for correcting
problems and creating more lean processes --
- Why you should join Catalent:------- --Defined career path and
annual performance review and feedback process--------- --Potential
for career growth on an expanding team within an organization
dedicated to preserving and bettering lives--------- --Dynamic,
fast-paced work environment------- --Generous 401K match and Paid
Time Off accrual--------- --Medical, dental and vision benefits
effective day one of employment--------- --Tuition
Reimbursement--------- --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, Chantilly , Specialist, QA Raw Materials, Other , Severn, Virginia
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