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Director
Quality Control
New
Jersey
The
Director of Quality Control is responsible for managing all aspects of
Quality Control, including data analysis, which involves product releases
as well as monitoring the performance of the released products, and
overseeing the general laboratory operations.
Responsibilities:
On-time
release of quality products including reviewing the QC specifications and
testing protocols to ensure that they are adequate to control the quality
of the product and maintain lot-to-lot consistency.
Monitoring
of product quality post-release by reviewing trends that may become
evident in the QC data as well as in reports from the field and/or
performance on external proficiency programs.
Investigation
of product issues and notifying management when adverse trends are
confirmed for further action.
SOPs
that govern QC to ensure that they are both complete and appropriate to
ensure product quality and that the staff is fully trained.
Ensure
that QC is fully compliant with state and federal regulations.
The
development and training of the QC staff.
New
Product Validations as part of the Design Control process when introducing
a new product.
Education
and Experience:
Doctoral
degree (Ph.D.) in Clinical Chemistry or related field or
Bachelor/Master’s degree with 10 years experience in a related field.
Experience
in immunoassay is essential.
Experience
in a clinical chemistry laboratory or diagnostics is preferred.
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