Senior Quality Assurance Specialist
Kelly Science, Engineering, Technology & Telecom, Rochester, NY, United States
Kelly Science is seeking a
Senior Quality Assurance Specialist
for a
short term contract
with a growing company located in
Rochester, NY.
Pay:
$45-60/hour
Shift:
Monday-3:30pm (flexible)
Work Model:
100% on-site
Employment Type:
3-5 month contract
Job Responsibilities
Manage and handle deviations, CAPAs, and change controls across the workflow.
Review and approve deviations and change controls, ensuring appropriate detail in all documentation.
Investigate product complaints, analyze batch records and associated data, and identify resources needed for thorough investigations.
Collaborate across disciplines to determine and implement corrective and preventive measures for quality improvement.
Coordinate and summarize investigation documentation, including submitting complaints for final QA approval and assisting with CAPA preparation.
Analyze complaints to identify trends and provide reviews for annual product evaluations.
Develop, document, and implement standardized business processes; utilize quantitative techniques to monitor performance.
Evaluate and enhance SOPs, implement change control documentation, and drive efficiency improvements while maintaining effectiveness.
Apply knowledge of regulatory requirements and industry trends to advance process quality and compliance.
Qualifications
Bachelor's degree in a scientific related field
5+ years of quality assurance experience within a FDA regulated, fast paced environment; preferably pharmaceuticals.
Experience in managing quality investigations including CAPAs, change controls and deviations. Experience in laboratory deviations is highly desirable.
Must be able to pivot when priorities change, collaborate with others and work well in fast paced environments.
Interested? Please apply today for immediate consideration!
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Senior Quality Assurance Specialist
for a
short term contract
with a growing company located in
Rochester, NY.
Pay:
$45-60/hour
Shift:
Monday-3:30pm (flexible)
Work Model:
100% on-site
Employment Type:
3-5 month contract
Job Responsibilities
Manage and handle deviations, CAPAs, and change controls across the workflow.
Review and approve deviations and change controls, ensuring appropriate detail in all documentation.
Investigate product complaints, analyze batch records and associated data, and identify resources needed for thorough investigations.
Collaborate across disciplines to determine and implement corrective and preventive measures for quality improvement.
Coordinate and summarize investigation documentation, including submitting complaints for final QA approval and assisting with CAPA preparation.
Analyze complaints to identify trends and provide reviews for annual product evaluations.
Develop, document, and implement standardized business processes; utilize quantitative techniques to monitor performance.
Evaluate and enhance SOPs, implement change control documentation, and drive efficiency improvements while maintaining effectiveness.
Apply knowledge of regulatory requirements and industry trends to advance process quality and compliance.
Qualifications
Bachelor's degree in a scientific related field
5+ years of quality assurance experience within a FDA regulated, fast paced environment; preferably pharmaceuticals.
Experience in managing quality investigations including CAPAs, change controls and deviations. Experience in laboratory deviations is highly desirable.
Must be able to pivot when priorities change, collaborate with others and work well in fast paced environments.
Interested? Please apply today for immediate consideration!
#J-18808-Ljbffr