QA Product Manager
Company: Disability Solutions
Location: Saint Petersburg
Posted on: April 25, 2024
Job Description:
QA Product Manager Position SummaryThe QA Product Manager is
responsible for providing Leadership and Quality Assurance
Management support within at Catalent's St. Petersburg site. The
Department has the responsibility for Quality aspects related to
Quality Systems, Finished Product Batch Release, and Change
Control.The QA Product Manager provides customer service, with the
highest integrity, focused on quality and compliance with
partnership with Catalent St. Petersburg's customers and internal
organizations. This position serves as a representative for their
clients within the Catalent St. Petersburg site. The QA Product
Manager is responsible for the overall Quality Assurance review and
approval of all technical documents including but not limited to:
a) change controls and associated Master documents, including but
not limited to MERs and material Specifications; Product
specifications; Test methods; Master Batch Records; Master Shipper
Labels; all equipment IQ/OQ/PQ documents regarding equipment,
utilities, and computer systems; b) process improvement projects
and Product Development Projects; c) all product process validation
and cleaning validation documents; d) all Preventive Maintenance
and Calibration work--The Role--- Primary quality liaison for
clients and internal customers. Is expected to become the Subject
Matter Expert for the client products, processes and
requirements.--- Responsible for maintaining, developing, and
nurturing the client partnership to ensure alignment and
consensus.--- Effective coordination of functions across the site
and with clients to drive timely review, approval, and closure of
investigations, change controls, audit tasks, corrections, and
effectiveness checks.--- Generate quality metrics, trackers, and
reports for management and clients to characterize the health of
the client relationship and state of quality systemstechnical---
Provide QA Technical recommendations based on trend analysis to
eliminate future problems.--- Participates in Product
Development/Validation/Engineering project meetings to provide
Quality Assurance input with respect to compliance to cGMP
requirements.--- Reviews and approves technical documents, such as,
but not limited to:--- Technical Services Protocols and Reports;The
Candidate
- Bachelors Degree in Science (Chemistry, Microbiology or Biology
preferred) required
- A minimum of five to ten years related experience and/or
training and/or equivalent combination of education and experience
in the QA pharmaceutical industries.--
- Prior experience working with validation, manufacturing or
product development preferred.--
- Proven ability to multi-task and demonstrate diplomatic
skills.--
- Must possess excellent English verbal and written communication
skills.--
- Intermediate to proficient skills in Microsoft Office
applications
- Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and
occasionally lift to 15 pounds; no lifting greater than 44.09
pounds without assistance. Be accessible to manufacturing floor and
office staff and to use required office equipment. Specific vision
requirements include reading of written documents and use of
computer monitor screen frequently.Why You Should Join Catalent
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
---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.--Catalent is committed to the health and
safety of its employees, visitors and the customers and patients we
serve. As a result of the global pandemic, we have modified many of
our recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------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, Town-n-Country , QA Product Manager, Executive , Saint Petersburg, Florida
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