QC Development Manager

POSITION SUMMARY:

Manager, QC Development is responsible for modifying existing methods and/or developing and optimizing new QC methods to support routine lot release of reagents and kits used in the CLIA laboratory. Provides technical and scientific operations support in event of deviations and/or non-conformance issues arising for reagent preparation and/or qualification.

PRIMARY RESPONSIBILITIES:

• Primary responsibilities include leading a team responsible for development and optimization of reagent Quality Control (QC) Tests and associated bio-chemical process optimizations to support routine reagent and kit qualification. • Analyze data and prepare documentation for QC method validation, author and revise QC testing SOPs and reports to ensure the successful implementation of assays in the laboratory. • Oversee technical transfer of new product QC methods from Research and Development into Operations, addressing process development needs for implementation. • Provide technical and scientific operations support in event of deviations and/or non-conformance issues arising for reagent preparation and/or qualification to ensure disposition(s) for impacted material(s) are driven by scientifically rational input. • Personnel management includes: provide technical assistance, employee development, coaching and counseling, administering performance appraisals, and enforcing company policies through appropriate disciplinary measures

QUALIFICATIONS:

• Ph.D. in Molecular…