QA Product Manager
Company: Disability Solutions
Location: Saint Petersburg
Posted on: September 21, 2024
Job Description:
QA Product ManagerPosition SummarySt. Petersburg is our primary
soft gel development and manufacturing facility in North America
with capacity of 18 billion capsules per year. --Within the
Catalent network, we offer a broad range of integrated formulation
and analytical services to solve difficult development and
manufacturing challenges. 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 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 order
requirements for critical systems.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 systems
- 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.
- Provides feedback to the appropriate department (i.e. regarding
the compliance and adequacy of the documents reviewed as it
pertains to cGMPs, site SOPs, and FDA/MCA regulatory
guidelines).
- Provide support to internal, client, and regulatory
audits.
- Engage in monitoring quality systems to maintain awareness and
audit/inspection readiness at all times.
- All other duties as assigned.The Candidate
- Bachelor's Degree in Science (Chemistry, Microbiology or
Biology preferred) required with a minimum of five years of 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.
- Prior quality assurance experience is required.
- Working knowledge of cGMPs and/or OSHA regulations
required.
- Certified Quality Engineer is a plus.
- Excellent oral and written communication skills a must.
- Proficient in Microsoft Word, Excel, Access and Power
Point.
- Ability to speak effectively and present before groups within
the organization.
- Ability to review and evaluate technical documents and
determine impact to processes and systems in place.
- 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 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, St. Petersburg , QA Product Manager, Executive , Saint Petersburg, Florida
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