Quality Systems Specialist
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.
- 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.