Quality Control Specialist I

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Job description

Job Description

The Quality Control Specialist Iis responsible for the second person review of selected data generated in the laboratory. Assignments are generally overseen by a Team Leader. The Quality Control Specialist Imust be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations.

This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to SGS customer base.

REPORTING LINE

Reports to the Quality Control Supervisor, Quality Control Team Leaderor Department Manager.

SPECIFIC RESPONSIBILITIES

OUR PROMISE TO OUR CUSTOMERS

At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.

SERVICE RESPONSIBILITIES TO CUSTOMERS

Perform data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include biology andinstrumentation data reviews.

Perform reviews for reagent and standard preparations and their assays or suitability testing and/or media preparation and associated media checks. Perform equipment performance logs review, auxiliary log book reviews, stability study pull reviews, audit trail reviews and metrology reviews.

Perform special project data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include biology andinstrumentation data reviews.

Perform Out of Specification (OOS) and Method Validation Failure (MVF) biology investigations following staff performance of customer test requests in a timely and effective manner.

Ensure that all testing submitted by customers is completed within established parameters governing Company quality and regulatory compliance specifications

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS

Ensure that all reasonable requests from Department Management pertaining to review of laboratory data supporting a given test or group of tests are met in a timely and effective manner.

Play a role in Departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.

Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory.

TECHNICAL RESPONSIBILITIES

Maintain thorough knowledge and understanding of all Standard Operating Procedures (SOPs) pertaining to the review process.

Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory.

May be invited to participate in the preparation and review process for appropriate department SOPs, worksheets and data forms.

ADMINISTRATIVE RESPONSIBILITIES

Adherence to relevant SOPs governing documentation and reporting.

Adherence to applicable personnel policies regarding time clock, telephones, sick days, vacation days, etc.

Participation in general staff training sessions as these are scheduled.