Manager, QA (Product Development)
Company: Disability Solutions
Location: Saint Petersburg
Posted on: May 4, 2024
Job Description:
Manager, QA (Product Development)Position SummaryThe Quality
Assurance Department 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,
Change Control, Client interface, Lab Investigations, Deviations,
Complaints, etc. The focus of each QA Manager may be dependent upon
the needs of the business and structure of the Quality Unit and
could include all or some aspects of the Quality function.The
Product Development QA Manager provides quality focused customer
service, with the highest integrity, in partnership with Catalent
St. Petersburg's internal technical departments. This position is
expected to serve as a representative for Catalent's strategic
clients as well as support the clients with products that have
technical opportunities for improvement.-- --The QA Manager will
act as an initial escalation decision maker within the quality
organization.-- The QA Manager may oversee a staff from five to ten
including Sr QA Technical Reviewers and QA Product
Managers.----Responsible for ensuring the site is following cGMP
guidelines, adherence to Catalent Corporate Quality Policies and
applicable Catalent Pharma Solutions quality standards across the
area of focus.-- Position requires partnership with other
functional areas (e.g. Product Development, Operations, Customer
Service, Validation, Quality Control, etc.) to ensure continued
compliance for the area/site.-- Will provide directional support
and as required, hands on, leadership to drive actions and
enhancements to the QMS.The QA 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 Master
Batch Records; Master Shipper Labels, Process recipes, various
technical protocols (Pre-Commercial Clinical Packaging Protocols,
Process assessment, Method Validation, Bulk Mfg Protocol and
Reports (non-GMP, Clinical, Registration, Process Validation,
Product Transfer, etc.), Risk Assessment, Formulation Reports,
Development Reports, Material Evaluation Requests, Material and API
Specifications; Product specifications; Test methods; b) RTE,
Process improvement projects and Product Development Projects; c)
Stability Protocols and cleaning validation documents; d)
Deviations, Laboratory Investigations and other ad hoc
documentation.--The Role
- Primary quality liaison for strategic clients and internal
customers. In addition, the role is expected to take on existing
clients/products that have opportunities for improvement. Is
expected to become the Subject Matter Expert for the client
products, processes and requirements and provide support in driving
continuous improvement.--
- 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.
- Bulk Mfg Protocols and Reports (non-GMP, Clinical,
Registration, Process Validation, Product Transfer)
- Master Batch Records; and Master Shipper Labels.
- Change Control, as it pertains to the above validated/qualified
systems and controlled documents
- Author and approval of deviations and laboratory
investigations
- 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 QA Technical support during the development and
manufacturing improvements throughout the design phase, technical
transfers and routine production.
- Provide support to internal, client, and regulatory
audits.
- Engage in monitoring quality systems to maintain awareness and
audit/inspection readiness at all times.
- Ability to investigate and analyze technical reports and
technical concerns to determine trends affecting future designs,
production activities.
- Potential to oversee and provide guidance to direct reports
by:
- Assisting in performance managementThe Candidate
- Bachelor's degree in science (Chemistry preferred) required or
equivalent;
- A minimum of five to ten years related experience and/or
training and/or equivalent combination of education and experience
as QA in pharmaceutical industries.--
- Prior experience working with quality control, manufacturing,
product development preferred (Feasibility Batches, Clinical,
Registration, Product Transfer)
- Proven ability to multi-task and demonstrate diplomatic
skills.--
- Must possess excellent English verbal and written communication
skills.--
- Proficient skills in Microsoft Office applications
- Working knowledge of cGMPs and/or OSHA regulations
required.
- Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds. 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
- 152 hours of PTOCatalent 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, Bradenton , Manager, QA (Product Development), Executive , Saint Petersburg, Florida
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