Supervisor, QC Analytical
Company: Disability Solutions
Location: Severn
Posted on: September 28, 2024
Job Description:
The Supervisor, QC is responsible for leading analytical
testing, investigations, and key deliverables for the Quality
Control (QC) group.--The Supervisor, QC must demonstrate expert
technical knowledge, mentors direct reports on basic
scientific/regulatory principles, possess initiative, and maintains
a strong commitment to scientific excellence as well as a strong
cGMP understanding and mindset to help drive compliance within the
department.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.Shift: Monday-Friday 8am-5pmThe role:
- Supervise the day to day operations in assigned area of the QC
department.
- Ensure staff are fully trained on all cGMP manufacturing
operations and documentation and adhering to safety guidelines
- Drive department process improvements which will increase
efficiency and compliance
- Ensure department adherence to batch record, stability protocol
timelines and deliverable dates
- Ensure department adherence to target deadlines for deviations,
laboratory investigations, and trackwise actions
- Responsible for document writing (laboratory investigations,
out of specifications, deviations, CAPAs), data
interpretation/presentation, statistical analysis, and
trending
- 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.
- Understands company/department goals and practices and apply
them when resolving a variety of problems.
- Oversee assays such as ELISA, DNA/RNA extraction and gel
electrophoresis, qPCR, RT-PCR, HPLC and Capillary
Electrophoresis
- Generate internal and external documents such as assay
protocols, summary reports, and SOPs
- Work with clients to support resolution of concerns/hurdles
seen during GMP manufacturing campaigns, on going stability
studies, and method verifications.The candidate:
- Bachelor in a Life Sciences discipline with 6 - 8 years of
experience working in a cGMP QC laboratory.
- Masters' in a Life Sciences discipline with 4 - 6 years of
experience working in a cGMP QC laboratory.
- Experience with ELISA, ddPCR, qPCR, Empower 3 preferred but not
required.
- Expert relevant to QC analytical methods used for protein
chemistry and molecular biology
- Experience within the biologic, pharmaceutical, or medical
device industry performing direct hands-on work in QC function with
a strong familiarity of general GMP practices
- Experience in writing SOPs
- Expert experience with biochemistry, as well as
generating/reviewing the documentation that supports such work
- Expert knowledge and ability to apply basic scientific and
regulatory principles to solve operational, as well as routine
quality tasksWhy 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, Severn , Supervisor, QC Analytical, Other , Severn, Maryland
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