Quality Site Specialist

Works under limited direction with work being evaluated upon completion to ensure objectives are met

Determines and develops approach to solutions.

Frequent interorganizational and outside customer contacts.

Represents the department on projects and may perform in project leadership role.

Represent the department and is the main quality point of contact at the DC level.

Provides resolutions to a diverse range of complex problems using judgement within defined policies and practices.

Execute equipment qualification and mapping

Execute qualification protocols

Manage the temperature monitoring system

Draft quality assurance policies and procedures

Interpret and implement quality assurance standards

Evaluate adequacy of quality assurance standards

Review the implementation and efficiency of quality and inspection systems

Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality

Document internal audits and other quality assurance activities

Investigate customer complaints and non-conformance issues

Collect and compile statistical quality data

Analyze data to identify areas for improvement in the quality system

Develop, recommend and monitor corrective and preventive actions

Prepare reports to communicate outcomes of quality activities

Coordinate and support on-site audits conducted by external providers

Evaluate audit findings and implement appropriate corrective actions

Monitor risk management activities

Responsible for document management systems

Assure ongoing compliance with quality and industry regulatory requirements.

Promotes understanding of quality standards and processes with Distribution Directors in the DC.

Identify training needs and organize training interventions to meet quality standards

Ensures proper preparation, execution and follow-up of Regulatory Inspections by maintaining the inspection file, managing audit documents and response actions.

B.SC. in Chemistry, Biology or equivalent experience.

Quality inspection, auditing and testing experience

Experience in execution of equipment qualification or mapping

Experience with implementation of corrective action programs

Product or industry-specific experience

Strong computer skills including Microsoft Office, QA applications and databases

Knowledge of tools, concepts and methodologies of QA

Knowledge of relevant regulatory requirements

4+ years of relevant experience

Demonstrate strong leadership in a professional environment

Ability to manage time and prioritize tasks is an essential characteristic

Communication skills - verbal and written

Data collection, management and analysis

Problem analysis and problem solving

Planning and organizing

Judgment

Decision-making

Customer service orientation

Ability to motivate in a teamwork environment

Capacity to work under limited direction.

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