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Senior QC Analyst - QC Analytics

Quality & Laboratory
Deirdre Duboy
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Job Reference: JO-2006-65242_1592309649


Primary Responsibilities:

· With a high degree of technical flexibility, work across diverse areas within the lab

· Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

· Report, evaluate, back-up/archive, trend and approve analytical data.

· Troubleshoot, solve problems and communicate with stakeholders.

· Initiate and/or implement changes in controlled documents.

· Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

· Write controlled documents, perform assay validation and equipment qualification/ verification.

· Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

· Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

· Approve lab results

Key Requirements:

· Bachelor's degree in a Science related field

· Minimum of 3+ years in a GMP lab

· Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels, Capillary Electrophoresis, pH, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing.

· Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.

· Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

· Confident communicator who can work under minimum supervision

· Candidates that can take ownership of their responsibilities

· Team player

This role will support manufacturing operations, as such some extended hours, weekend or shift work flexibility may be necessary as required.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
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Talent Consultant:
Deirdre Duboy
Deirdre Duboy
Talent Consultant
Quality & Laboratory
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