QC Separations Analyst

POSITION SUMMARY:

This position is responsible for carrying out tasks and projects related to testing procedures equipment and lab utilities as required by Good Manufacturing Practice (GMP).

Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

Requirements

GENERAL SCOPE OF RESPONSIBILITIES:

Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.

Review and approval of laboratory test results.

Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH USP and EP guidelines.

Executes validation operation maintenance calibration and troubleshooting of equipment and it s associated software.

Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.

Ensures that all testing is completed reviewed and approved within agreed turnaround times.

Ensures QC activities are carried out in compliance with product license commitments cGMP and company quality standards.

Trains other QC analysts in laboratory methods and procedures when required.

Writes/updates and reviews TMs SOPs and WIs as required.

Writes and reviews invalid assays nonconformances and deviations as required.

Actively participates in JSI lean initiatives such as Kaizen 6S and Gemba.

Is an active member of the QC group and provide assistance with other group activities as required.

Communicates relevant issues to the QC Team Leader promptly.

Maintains and develops knowledge of analytical technology as well as cGMP standards.

SPECIFIC TESTING EXPERIENCE REQUIRED:

HPLC

Capillary Electrophoresis

UPLC/Mass Spec (desirable)

KEY COMPETENCIES REQUIRED:

Excellent interpersonal skills.

Ability to operate as part of a team is critical.

Excellent communication skills both written and verbal.

Good knowledge of LIMS Track wise and Electronic documentation systems.

Good knowledge of Microsoft Office applications such as word Excel PowerPoint

Experience working in a high throughput laboratory environment.

Excellent technical writing skills.

Customer focus.

Attention to detail.

Strong problemsolving skills.

Results and performance driven.

Adaptable and flexible.

QUALIFICATIONS AND EXPERIENCE:

BSc (Honors) in a scientific/technical discipline.

A minimum of 2 years experience in a QC laboratorytesting environment within the biological and/or pharmaceutical industry.

Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.

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