Quality Administrator

West Chester, OH


Contract Duration 6-36 months


Rate: Negotiable


Salary: NA, $1.00

• Excellent employment opportunity for a Quality Administrator in the West Chester, OH area.
• Requires working in various Controlled/Non-Classified areas.
• Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
• Operate sterilized systems and equipment utilizing aseptic technique, and/or in controlled aseptic environments.
• Operate production equipment without supervision after certification.
• Monitor equipment for performance and problem indicators, assist with troubleshooting.
• Conduct process checks to ensure that processes are operating within required parameters.
• Ensure proper documentation practices during production including batch record and log entries as required.
• Participate in spill control, handling of hazardous materials, and first aid.
• Monitor production area to ensure compliance with regulatory requirements.
• Attend team meetings to discuss progress, and/or continuous improvement initiatives.
• Participate in daily shift change meetings.
• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
• Conduct environmental monitoring (microbiological) activities for controlled and aseptic areas, perform aseptic sampling to support the release of product, and perform aseptic sampling of personnel performing aseptic operations.
• Enter environmental monitoring results utilizing MODA computer system.
• May serve as the link between the PET team and QC Microbiology for day-to-day activities, such as schedules, sample submissions, and workload planning.
• Review completed production documentation (for example: batch records, log books, etc.) for quality, completeness, and cGMP compliance.
• Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation. Complete all required training.
• Perfors cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform shift cleanings, including spot and more detailed cleanings including sanitizing equipment and components as well as visual inspections.

• Advance education beyond high school in science-related field
• 3 Year of experience in a pharmaceutical or cGMP regulated environment
• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
• Individual must be capable of keeping accurate records, performing mathematical calculations.
• Aptitude with computerized systems.
• Ability to both function in team environment, and in an individual capacity with minimal over-site.
• Aseptic production experience
• Advance education beyond high school in science-related field
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures
• Experience with environmental monitoring or microbiological sampling