CSV Compliance: Oversee the validation of laboratory computer systems (CSV), ensuring that software and automated analytical instruments are compliant with data integrity and regulatory requirements (e.g., 21 CFR Part 11).
Laboratory Support: Maintain analytical instrumentation and provide technical expertise for troubleshooting complex laboratory assays.
Accurate and timely issuance of Test Results and Certificates of Analysis (COA).
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Directly supervises quality assurance team lead, quality assurance engineers and testers including the preparation and delivery of staff performance evaluations and career development activities.
To attend customer enquiries related to quality issue, customer claim, customer return and coordinate customer and vendor audit. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments.
Implements ongoing quality improvement processes working with interdepartmental teams and maintains product consistency throughout product cycle, to include the design, define and build phases through quality checkpoints and testing.
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Manage calibration, maintenance, and procurement of laboratory instruments, equipment, and consumables; maintain equipment ledgers and participate in equipment acceptance.
Ensure laboratory safety, maintain infrastructure, and coordinate with auditors, clients, and third parties for certifications and system audits.
Maintain and update documentation, prepare reports, and drive continuous improvement of laboratory processes and performance.
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Lead the preparation and updating of Prototype Control Plans, Trial Production Control Plans, and Mass Production Control Plans.
Responsible for fixture/gauge solution review, monitor the gauge development process, and ensure successful acceptance and MSA completion to meet usage requirements.
Responsible for consolidating quality issue lists during all development stages, tracking problem resolution, and preparing 8D reports for customer feedback issues.
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