Quality Control Analyst

Description

Execute stability program and sample staging in stability chambers.

Areas of Impact: Responsible for training / mentoring new QC Analysts Perform analyses Checks and control record documentation Additional responsibilities when ready - will provide support to Analysts GCA 11 (will participate in investigations, drive and implement improvement projects, etc.).

These additional requirements will be captured in the capability matrix of the career path in the QC lab Job Aspect: Requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills Builds knowledge of the organization, processes and customers Solves a range of straightforward problems Analyzes possible solutions using standard procedures.

Conducts non-conformance tests of manufactured, packaged or tested product Prepares and monitors quality statistics and report Performs analyses, inspection, and tests of products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with company standards, customer and governmental regulatory requirements, and tolerance specifications for the chemical or physical property Competencies: Can train others Works independently working with discretion and judgment. 

Qualifications

Requires working knowledge or skills developed through formal training or experience.

Work is primarily achieved by an individual or through project teams. Capabilities / Technical Skills: As per skills matrix per site process Qualifications / Trainings: GxP certification - Internal, based on the site and Job Specific training system. Quality / work procedures trainings

Education: (Expected level of Education, may be impacted by Technology / Site Complexity) Bachelors degree in applicable discipline (chemistry, pharmaceutical or biology) required 3+ years’ quality experience in pharmaceutical / biotech required Master's Degree is conditionary / a plus.