Quality Administrator

West Chester, OHContract Duration 6-36 monthsRate: NegotiableSalary: NA, $1.00Responsibilities: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.Experience:Advance education beyond high school in science-related field3 Year of experience in a pharmaceutical or cGMP regulated environmentMust 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 experienceAdvance education beyond high school in science-related fieldExperience working in a LEAN manufacturing environmentKnowledge of cGMPs and FDA policies/proceduresExperience with environmental monitoring or microbiological sampling