Supervisor, Client QA
Company: Disability Solutions
Location: Severn
Posted on: October 24, 2024
Job Description:
The Supervisor, Client QA is responsible for providing QA
support and oversight of Client Projects from start to finish for
GMP Manufacturing of master/working cell banks, biological bulk
drug substance and finished drug product.-- Overseeing the Client
Support team and serves as the dedicated Client QA Representative
and liaisons with the Client and other functions including Project
Management, Process Development, Technology Transfer,
Manufacturing, Quality Control and other functions within the
Quality Assurance unit. Responsibilities include tracking and
reviewing technology transfer documents, specifications, master
batch records, change requests, deviations and failure
investigations supporting the release of manufactured
material.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. 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:
- Supervision of Client Support 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.
- Drive engagement and create a culture where employees are
motivated to do their best.
- Oversee daily activity for the group to ensure quality results
Performance management for direct reports.
- Provides dedicated QA support to client projects and client
interactions & meetings.-- Provides quality oversight of GMP
operations for the manufacture of master/working cell banks, bulk
drug substance and/or final drug product
- Involved from inception of a client's project until project
closure. Supports Clinical and Commercial QA activities, including
initial process development and non-clinical batch production.
- Responsible for tracking, documenting and presenting Quality
Metrics presentations for Client Projects (on time batch release,
right first time, deviations per batch)
- Oversee QA Support with clients during initial and subsequent
manufacturing campaigns
- Supports GMP departments in reviewing and approving deviations
and failure investigations, including root cause analysis,
evaluating product/facility impacts, and evaluating effective
corrective and preventive actions (CAPAs)
- Performs risk analysis and mitigation, using available tools
such as FMEA, when needed.The candidate:
- Masters' degree in a Scientific, Engineering or Biotech field
with 4 - 6 years' experience in Quality Assurance/Quality Control
within biologics, biopharmaceuticals, or a regulated industry.
- Bachelor's degree in a Scientific, Engineering or Biotech field
with 6 - 8 years' experience in Quality Assurance/Quality Control
within biologics, biopharmaceuticals, or a regulated industry.
- Strong knowledge base 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.The anticipated salary range for
this position in Maryland is $93,280 - $128,260 plus an annual
bonus target.--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:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
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, Montgomery Village , Supervisor, Client QA, Other , Severn, Maryland
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