Assoc Quality Technician Jobs

Manages the quality control activities of an organization.

Requires breadth of professional field and industry knowledge.

Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.

Ensures budgets, schedules, and performance requirements are met.

Judgement is required in resolving complex problems based on experience.

10-12 years related experience required.

Demonstrated audit conduct and management experience in GCP disciplines

Maintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organization

Equivalent combination of education and experience.

Manages and/or participates in audits and regulatory inspections;

Minimum 10 years of relevant experience in pharmaceutical/biotech

Minimum 6 years GCP Quality Assurance experience preferred

Knowledge of CLIA and CAP laboratory certification

Maintain and manage QA provided GLP/GCLP trainings

Manage GLP/GCLP CAPAs and Deviations

Conduct and manage internal GLP/GCLP process and systems audits

An understanding of and practical experience establishing and fostering compliance with GLP/GCLP regulations and guidelines

Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 5-10 years of experience

Verify receipt of calibration certifications and issue “out of tolerance notifications” to users when equipment tests outside of acceptable parameters.

Assist with the flow of material through receiving inspection. Includes assisting with non-conforming material, acquiring certifications from suppliers, verification/creation of labels.

Working knowledge of MS OFFICE

Maintain the recall of calibration equipment and coordinate with the outside vendor for pick up and delivery.

Act as a liaison between functions within the organization.

Assist current inspectors and quality engineers with tasks to improve the flow of material.