Title: Administrative Coordinator
Department: Quality Assurance
Reports To: Quality Lead
FLSA Status: Hourly
The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility.
Collects, organizes, monitors, and distributes information related to quality functions, possibly including but not limited to compliance to and/or documentation of quality management standards, regulations, and corporate SOPs. Typically generates reports/documents using computer skills and distributes to various users in the organization.
Responsibilities/Tasks (include but not limited to)
Aide in Management of Change (MOC) to include SOPs, Change Controls and Deviations.
Performing routine tasks regarding all phases of GMP Quality Documentation. Coordinating document revision, originating SOP documentation, internal log controls etc. Documentation practices must be compliant and in accordance to CFR 210 and 211.
Aide in Establishing Raw Material Library
Uses computer software to create Standard for Raw Material in Jasco FT/IR (Fourier Transform Infrared) Spectrometer System
- No experience needed
- Simply place sample on disk using a pipet
- Click Run in the software
- Save analysis
- Clean disk
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
Perform other related duties as assigned to meet departmental and Company objectives.
Maintains safe and healthy work environment by following standards and procedures, complying with legal regulations
Requires contact/communication with employees in all departments at all levels.
Provides information in a tactful and professional manner
Education, Training, Skills and Experience Requirements:
Minimum High school diploma or equivalent education required
1-3 years of related experience preferred
Must be detail-oriented
Should possess good organizational and time management skills
Possess good verbal and written communications
Basic knowledge of Good Manufacturing Practice (GMP) / Good Lab Practices (GLP) required
Intermediate computer skills (Microsoft Office products including Word, Excel and PowerPoint) a plus
Bilingual (English and Spanish, spoken and written) a plus
Experis is an Equal Opportunity Employer (EOE/AA)