Senior Specialist, QA OTF
Company: Disability Solutions
Location: Severn
Posted on: October 25, 2024
Job Description:
Sr. 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 Sr. Specialist, QA-OTF 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 2+ years' experience in Quality Assurance/Quality
Control/Manufacturing within biologics, biopharmaceuticals, or a
regulated industry OR Bachelor's degree in a Scientific,
Engineering or Biotech field with 4+ 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, EDMS 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--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, Franconia , Senior Specialist, QA OTF, Other , Severn, Virginia
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