Supervisor, QA OTF Support
Company: Disability Solutions
Location: Severn
Posted on: October 31, 2024
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Job Description:
Supervisor, QA OTF Support--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 Supervisor, QA OTF Support
is responsible for providing quality oversight for the "QA on the
Floor" program in accordance with Catalent policies, standards,
procedures and Global cGMP. Functional responsibilities include
ensuring manufacturing compliance with applicable procedures and
batch records, providing real time review of manufacturing batch
record documentation and logbooks, and working with operations on
the floor to resolve manufacturing issues. This position is
required to be present on the floor for 70% of the day.--This
position will follow a 7AM-7PM 2-2-3 rotating schedule and is 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
Catalentemployee.The Role:----- Provide oversight of the "QA on the
Floor" program and supervision of OFT processes and personnel.-----
Ensure staff are fully trained on all cGMP manufacturing operations
and documentation and adhering to safety guidelines; build
effective teams that apply their diverse skills and perspectives to
achieve common goals; oversee daily activity for the group to
ensure quality results Performance management for direct
reports.----- Drives and owns the "Quality on the Floor" program by
facilitating the desired 'way of working' and a quality culture;
plans and coordinates the activities of the OTF team to ensure
coverage for all manufacturing activities.--- Provide QA oversight,
technical expertise and leadership across all aspects of product
manufacturing and operations support; develop and update relevant
procedures; monitor, participate and oversee the real time batch
record review process, including escalation of issues while on the
floor.----- Ensure manufacturing compliance with applicable
procedures and batch records; review manufacturing shop floor
documentation, including logbooks, calibrations etc; play a key
role with resolution of quality investigations and CAPAs.--- Ensure
that own and teams KPI's, plans, targets and objectives are
effectively monitored and achieved. Including standard lead-times
and supporting the Business goals for e.g. RFT and OTD/ OTIF;
embrace and actively drive Practical Process Improvements (PPI).
Directs quality initiatives that accomplish continuous improvement
and enhance site quality system efficiencies.----- Partner with
manufacturing and key stakeholders to prioritize projects aligning
with the quality goals and objectives; --ensure quality events are
captured, investigated and closed appropriately in the Trackwise
system.----- Actively participates in training activities, managing
their individual training plan; also ensures interaction with other
shifts given the 24/7 operations.--- Leads by example, keeping in
mind organizational values, policies and goals. Develops people and
team coaching and collaboration; proactively partners with Human
Resources to attract and retain top talent and takes an active role
in ensuring new employee onboarding is a success.----- Other duties
as assigned.--The Candidate:--------- --Masters' 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 OR
Bachelor's degree in a Scientific, Engineering or Biotech field
with 6years' experience in Quality Assurance/Quality
Control/Maufacutring 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.--------- --Familiarity with
electronic systems, including developing and producing reports
using Microsoft products. LIMS, Master Control and Trackwise
knowledge preferred; Have the knowledge, and ability to apply basic
scientific and regulatory principles utilized to solve operational,
as well as routine quality tasks.--------- --Creative individual
with excellent analytical, trouble shooting, and decision-making
skills; ability to quickly learn new and novel manufacturing
processes supporting new clients; ability to produce results in a
fast-paced environment to meet client deadlines; able to work in a
team setting and independently, under supervision; creative
thinking with the ability to multi-task; commitment to ongoing
professional development.The anticipated salary range for this
position in Maryland is $93,280-128,260 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 , Supervisor, QA OTF Support, Other , Severn, Maryland
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