Lead Specialist, Client QA
Company: Disability Solutions
Location: Severn
Posted on: October 24, 2024
Job Description:
The Lead Specialist, Client QA is responsible for providing QA
lead 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.-- The Client QA Contact
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:
- 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.
- Tracks, documents and presents Quality Metrics presentations
for Client Projects (on time batch release, right first time,
deviations per batch)
- Works with clients during initial and subsequent manufacturing
campaigns
- Conducts review of master batch records during Technical
Transfer for client processes
- 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 $118,720-$163,240 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, Sterling , Lead Specialist, Client QA, Other , Severn, Virginia
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