Manager, QC Program Management
Company: Disability Solutions
Location: Severn
Posted on: October 19, 2024
Job Description:
The Manager, QC Client Services is responsible for providing
support and oversight to the QC Client Services Team as they
support the Quality Control and Batch Disposition departments,
ensuring samples are tested on time and QC deliverables as part of
client's analytical implementation.-- Manage the OTL for analytical
method implementation and support SMPs and Batch records
implementation review.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:
- Be the face of Catalent Quality Control during Client
onboarding
- Manage the day-to-day method establishment.
- Attend client meetings to establish testing and stability
protocols
- Ensure completion of project team assigned QC related
activities.
- Coordinate internal testing with Quality Control group
- Coordinate product and raw material testing with external
testing laboratories
- Coordinate with the stability group and clients to establish
stability studies.
- Review and approve client sampling plans.
- Review and approve batch records.-- Ensure sample testing
schedule is accurate.
- Develop and maintain QC client activities tracker.
- Communicate manufacturing and testing schedules to the Quality
Control group.
- Effectively communicates with clients on QC related
items/results.The candidate:
- Masters' degree in a Scientific, Engineering or Biotech field
with 6 - 8 years' experience Quality Assurance/Quality Control
function reviewing Analytical testing data for analytical assays
such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an
Analytical Chemist with documentation review.----
- Bachelor's degree in a Scientific, Engineering or Biotech field
with 8 - 10 years' experience Quality Assurance/Quality Control
function reviewing Analytical testing data for analytical assays
such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an
Analytical Chemist with documentation review.--
- Strong communication skills.
- Proficient in Good Manufacturing Practices (GMPs), 21 CFR
210/211/600s, USP and ICH Guidelines.----
- Have the knowledge, and ability to apply basic scientific and
regulatory principles utilized to solve operational, as well as
routine quality tasks.----
- Exposure to Lean Operational Excellence highly
desirable.----The anticipated salary range for this position in
Maryland is $118,720 $163,240 plus an annual bonus.-- 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 environmentCatalent 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, Lancaster , Manager, QC Program Management, Executive , Severn, Pennsylvania
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