Raritan, NJ 08869
Key Responsibilities:
QA oversight of LVV manufacturing process to ensure cGMP compliance.
Review Master Batch Records to confirm data is accurate, legible, and consistent with established GDP requirements.
Perform manufacturing documentation compilation and quality issue assessment for the release of Lentiviral Vector product.
Perform inspection and release of raw materials needed for LVV production, as required.
Support review, revision, or drafting Standard Operating Procedures (SOPs) for Quality department in relation to the LVV process.
Provide quality and compliance input for continuous improvement and corrective actions of GxP practices within the lentivirus vector manufacturing facility.
Collaborate in a team based, cross-functional environment to complete tasks required by shift schedule.
Maintain quality practices and perform tasks in accordance to state and federal regulatory requirements and cGMP requirements.
Collaborate with functional departments to resolve issues related to LVV production, batch review, and release.
Clear communication with other QA LVV team members, to ensure consistent performance, and identification of deviations.
Ensure readiness of records for regulatory inspections.
Review, compile, and organize data for trending.
Qualifications
Education:
Minimum of a Bachelor’s or equivalent University Degree in Science, Information Science, or equivalent technical field is required
Experience and Skills:
Required:
Minimum 4 years of relevant work experience
Experience in Quality Assurance and/or Quality Systems Compliance
Knowledge of cGMP and FDA regulations
Good written and verbal communication skills
Preferred:
Experience working with large molecules or Lentivirus vector production
Knowledge of Good Tissue Practice or experience with cell-based manufacturing
Experience working in an aseptic manufacturing facility
Knowledge of EU guidance
Other:
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
Key Responsibilities:
QA oversight of LVV manufacturing process to ensure cGMP compliance.
Review Master Batch Records to confirm data is accurate, legible, and consistent with established GDP requirements.
Perform manufacturing documentation compilation and quality issue assessment for the release of Lentiviral Vector product.
Perform inspection and release of raw materials needed for LVV production, as required.
Support review, revision, or drafting Standard Operating Procedures (SOPs) for Quality department in relation to the LVV process.
Provide quality and compliance input for continuous improvement and corrective actions of GxP practices within the lentivirus vector manufacturing facility.
Collaborate in a team based, cross-functional environment to complete tasks required by shift schedule.
Maintain quality practices and perform tasks in accordance to state and federal regulatory requirements and cGMP requirements.
Collaborate with functional departments to resolve issues related to LVV production, batch review, and release.
Clear communication with other QA LVV team members, to ensure consistent performance, and identification of deviations.
Ensure readiness of records for regulatory inspections.
Review, compile, and organize data for trending.
Qualifications
Education:
Minimum of a Bachelor’s or equivalent University Degree in Science, Information Science, or equivalent technical field is required
Experience and Skills:
Required:
Minimum 4 years of relevant work experience
Experience in Quality Assurance and/or Quality Systems Compliance
Knowledge of cGMP and FDA regulations
Good written and verbal communication skills
Preferred:
Experience working with large molecules or Lentivirus vector production
Knowledge of Good Tissue Practice or experience with cell-based manufacturing
Experience working in an aseptic manufacturing facility
Knowledge of EU guidance
Other:
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
Raritan, NJ 08869
Key Responsibilities:
QA oversight of LVV manufacturing process to ensure cGMP compliance.
Review Master Batch Records to confirm data is accurate, legible, and consistent with established GDP requirements.
Perform manufacturing documentation compilation and quality issue assessment for the release of Lentiviral Vector product.
Perform inspection and release of raw materials needed for LVV production, as required.
Support review, revision, or drafting Standard Operating Procedures (SOPs) for Quality department in relation to the LVV process.
Provide quality and compliance input for continuous improvement and corrective actions of GxP practices within the lentivirus vector manufacturing facility.
Collaborate in a team based, cross-functional environment to complete tasks required by shift schedule.
Maintain quality practices and perform tasks in accordance to state and federal regulatory requirements and cGMP requirements.
Collaborate with functional departments to resolve issues related to LVV production, batch review, and release.
Clear communication with other QA LVV team members, to ensure consistent performance, and identification of deviations.
Ensure readiness of records for regulatory inspections.
Review, compile, and organize data for trending.
Qualifications
Education:
Minimum of a Bachelor’s or equivalent University Degree in Science, Information Science, or equivalent technical field is required
Experience and Skills:
Required:
Minimum 4 years of relevant work experience
Experience in Quality Assurance and/or Quality Systems Compliance
Knowledge of cGMP and FDA regulations
Good written and verbal communication skills
Preferred:
Experience working with large molecules or Lentivirus vector production
Knowledge of Good Tissue Practice or experience with cell-based manufacturing
Experience working in an aseptic manufacturing facility
Knowledge of EU guidance
Other:
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
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