Job Description:
Genus Lifesciences™ is a specialty pharmaceutical company
engaged in the development and commercialization of generic and
branded pharmaceutical products. Founded in 1999, Genus
Lifesciences™ employs over one hundred fifty professionals in all
phases of pharmaceutical operations, and its products are available
in pharmacies and other retail outlets throughout the United States.
In addition to its local presence, Genus Lifesciences™ has on-going
research efforts through global partnerships related to its
technology platforms.
Position: Manager, QA Operations
Department: Quality Assurance
Status: Exempt, Salary
Reports to: Director of Quality
Assurance
Job Summary:
The Manager, QA Operations will provide leadership and direction
to ensure the day-to-day quality systems and programs are aligned
with operational execution. Monitor and ensure that operations at
Genus facilities (12th Street & Fenwick) are conducted in
accordance with FDA regulations and meeting cGMP and other
applicable regulatory requirements. Monitoring, Directing, and
coordinating all Manufacturing Operations, Pharmaceutical Research,
Drug Development activities, Process Validation, Packaging
Validation, Cleaning Validation, Technical Services Operations,
Maintenance and Engineering activities.
This individual will oversee a team that monitors site
operations to identify opportunities and improvements to reduce risk
to GMP compliance and secure business. This individual will build
strong partnerships with Operations, QC, PD, Engineering, and
Maintenance staff to ensure compliance with site and FDA
requirements, ensuring customer demand is met as well as cGMP’s
specific to the site.
Essential Functions:
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Provides technical expertise and oversight in the
manufacturing, packaging, and sampling activities associated with
the manufacturing of commercial pharmaceutical drug products.
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Ensures accurate and timely documentation of manufacturing and
inspection activities.
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Ensures that all QA Inspection personnel are adequately
trained for the functions performed.
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Develop, design and write Standard Operating Procedures (SOP)
ensuring compliance with the company's policies and FDA regulations.
-
Completes Quality Assurance material disposition (acceptance
and rejection of material following quality systems) and assign
priorities to the QA team to support these activities as well.
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Monitor Review and release of commercial batches / Process
Validation batches / Exhibit and Submission batches to the Agency.
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Ensure that each lot of product that is manufactured and
distributed is tested complying to FDA and GMP requirements
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Taking necessary actions and initiatives to oversee the line
clearance and in-process QA activities.
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Support new product launch requirements.
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Ensure that all equipment and Instruments are qualified and
calibrated before use.
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Support continuous process improvement / enhancement projects
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Assist Quality Assurance Management during regulatory,
customer and third party audits.
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Support timely completion of GNR’s and CAPA records.
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Support quality metrics such as product disposition, customer
complaints, non-conforming product, etc., through a structured approach.
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Identify opportunities to improve quality and compliance
through trending and Statistical analysis.
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Additional responsibilities assigned by QA management.
