Quality Systems Specialist job in La Verne, USA

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Job type: Permanent

Discipline: Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Systems Specialist with a pharmaceutical company located in La Verne, CA. A successful candidate will have advanced knowledge of current Good Manufacturing Practices (GMPs) and pharmaceutical industry practices and experience with investigations, deviations, and data integrity.

Job Responsibilities:

Conducts a comprehensive and critical evaluation of Laboratory records including but not limited to content, results, data accuracy and scientific relevance, format and adherence to GMP.
Performs a thorough review of raw data and documentation to ensure compliance to applicable specifications and protocols.
Supports the laboratory testing group instrument qualification and method validation review.
Performs procedural and method revisions, where necessary.
Conducts GMP review of laboratory notebooks, logbooks and associated forms including electronic raw data to ensure compliance with the company's data integrity policy.
Supports OOS/OOT investigation and CAPA implementation
Conducts off hour (early morning/late night/weekends) data review to support production needs.
Provides new hire training.

Skills and Requirements:

Advanced knowledge of current Good Manufacturing Practices (GMPs) and pharmaceutical industry practices.
Strong knowledge of regulatory requirements surrounding Data Integrity.
Familiarity of analytic testing methods and validation including laboratory instrumentation.
Ability to apply critical thinking and good judgment.
Strong organizational and problem-solving skills.
Strong verbal, written, and interpersonal skills are required.
Proficiency in Microsoft Office and laboratory computerized systems such as Empower and/or LIMS.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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