Specialist, QA OTF
Company: Disability Solutions
Location: Severn
Posted on: October 18, 2024
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Job Description:
Specialist, QA OTF--Position 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 is
responsible for providing Quality Assurance support for GMP
Manufacturing of master/working cell banks, biological bulk drug
substance and finished drug product to be used for human
consumption. Responsibilities include providing QA On-The-Floor
(OTF) oversight of manufacturing including observing manufacturing
operations and reviewing documentation for compliance. 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. --This position is 1st shift 7AM-7PM 2-2-3 schedule and
is 100% on site at BWI/Harmans, 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:--------- --Provides dedicated QA
quality floor oversight of GMP operations for the manufacture of
master/working cell banks, bulk drug substance and/or final drug
product - 80% of day is spent on the floor.------- --Performs QA on
the Floor activities supporting client projects, including room
release, observing critical processes, reviewing batch
documentation in real time, cleaning documentation, logbooks and
resolving issues that occur during manufacturing; partners with
Manufacturing and other support teams------- --Performs Acceptable
Quality Limit (AQL) visual inspection of drug product; reviews and
approves batch documents for media and buffer prep solutions;
generates or revises GMP documentation such as Standard Operating
Procedures, Master Batch Record review and SMP's; compile
deviations as required when observed on the floor, and move to
completion within the required time frame------- --Perform audits
of manufacturing and support areas, including in-process batch
record review for adherence to internal procedures and Good
Documentation Practices------- --Identifies and implements
continuous improvement initiatives; participate in site and
corporate quality and process improvement initiatives; makes solid
quality decisions with limited oversight------- --Guides personnel
indirectly and directly involved in GMP operations pertaining to
cGMP compliance, internal procedures, regulatory requirements and
industry best practices.------- --Actively participates in training
activities, managing their individual training plan.------- --Other
duties as assigned.The Candidate:------- --Masters' degree in a
Scientific, Engineering or Biotech field with experience in Quality
Assurance/Quality Control/Manufacturing within biologics,
biopharmaceuticals, or a regulated industry preferred OR Bachelor's
degree required in a Scientific, Engineering or Biotech field with
2+ years' experience in Quality Assurance/Quality
Control/Manufacturing within biologics, biopharmaceuticals, or a
regulated industry.------- --Familiarity with Good Manufacturing
Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per
21 CFR Parts 600s, ICH Guidelines and EU GMPs; knowledgeable and/or
exposure to biological manufacturing processes including microbial
and cell culture cell banking, fermentation/cell culture,
purification and fill/finish; have the knowledge, and ability to
apply basic scientific and regulatory principles utilized to solve
operational, as well as routine quality tasks. ---------
--Familiarity with electronic systems, including developing and
producing reports using Microsoft products. --LIMS, Master Control
and Trackwise knowledge preferred.--------- --Creative individual
with excellent analytical, trouble shooting, and decision-making
skills; ability to quickly learn new and novel manufacturing
processes supporting new clients------- --Able to work in a team
setting and independently, under supervision--------- --Requires
the ability to produce results in a fast-paced environment to meet
client deadlines--The anticipated salary range for this position in
Maryland is $74,080---- ---$101,860 plus annual bonus, when
eligible. --The final salary offered to a successful candidate may
vary, and will be dependent on several factors that may include but
are not limited to: the type and length of experience within the
job, type and length of experience within the industry, skillset,
education, business needs, etc. Catalent is a multi-state employer,
and this salary range may not reflect positions that work in other
states.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
categories--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.--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, Severn , Specialist, QA OTF, Other , Severn, Maryland
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