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Home
> QA Quality Control
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Quality Assurance Specialist |
| Eligibility : |
Bachelor |
| Location : |
Los Angeles - CA California - USA |
| Designation : |
Quality Assurance Specialist |
| Details :: |
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Espoirbridge Recruiters |
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Espoirbridge is an agency that recruits candidates for clinical trail positions worldwide. Espoir Bridge Recruiters has a well established database of candidates and when this is combined with the expertise and energy of the consultants, we offer our clients the best opportunity to secure the most appropriate candidate.
Typical Work Activities
Typical work activities include:
Ensure timely completion of routine QA procedures, manufacturing, packaging and Formulation Development in-process testing checks, sampling and other agreed upon duties.
Ensure implementation of good laboratory (GLP), good clinical practices (GCP) and/or good manufacturing practices (GMP) (emphasis depends on employer's requirements and type of employer).
Ensure timely inspection, sign in and reconciliation of production rooms, equipment, raw materials and packaging components.
Report any discrepancies identified during routine operations monitoring and process testing in a timely manner to a QA Supervisor and provide assistance in the Quality Notification investigation.
Ensure that of all phases of manufacturing, packaging and Formulation Development comply with relevant SOPs (Standard Operations Procedures), GMPs (Good Manufacturing Practices) and safety guidelines.
Perform SAP transactions for various tasks completed to ensure that status of raw materials, packaging components, semi-finished products are correct both physically and electronically.
Participate as a member of the Quality Assurance Dept., to develop, implement and conduct in-process quality inspections through manufacturing and packaging facilities.
Assist in the development and execution of inspection systems that will track and report on production compliance metrics.
Communicate quality assessments (e.g. deviation trends, batch record reworks, audit findings, etc) and assist as a member of Quality Assurance to coordinate required corrective actions.
Review procedures and processes for accuracy, completeness and to ensure revisions are processed in a timely manner
Participate as a representative of the Quality Assurance Inspection Team as required for special cross-functional departmental meetings and/or committees
Auditing the Bioanalytical Laboratory for compliance with FDA GLP and other applicable regulations
Report findings to the Study Director/Management; monitor corrective actions.
Write, review, and distribute SOPs
Skills Required: Entry Requirements
Knowledge of GLP, GCP, and GMPs is a must. Excellent organizational and interpersonal skills. Prior experience in the pharmaceutical industry is preferred. Computer literacy - general word processor/database software. Excellent verbal and written communication skills. Good interpersonal skills/team player. Ability to assess and identify GMP and quality-related issues. Strong attention to detail. Demonstrated time management skills and the ability to work toward deadlines is required.
Experience/familiarity with Therapeutic Product Directorate (TPD) and Food and Drug Administration (FDA) regulatory requirements.
University degree, preferably in
Quality Assurance
Engineering
Chemistry
biochemistry
Computer Sciences
Pharmaceutical
biology
biomedical science
Business Administration
microbiology
medicine
molecular biology
pharmacology
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Espoirbridge is an agency that recruits candidates for clinical trail positions worldwide. Espoir Bridge Recruiters has a well established database of candidates and when this is combined with the exp
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| Salary : |
65000 USD |
| Company URL : |
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| Last Date : |
2007-12-20 |
| Address: |
Espoirbridge Recruiters |
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