Advanced Quality Technician

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.Provide quality assurance support to all areas of manufacturing and testing from new product development to Finishing. Review all Device History records for compliance to site, corporate and GMP/ISO/FDA regulations. Applies the principles of quality systems, divisional and corporate procedures in the area to ensure continuous compliance. This will be accomplished through review of device history records, active participation in the Corrective and Preventive Actions process as well as process improvements. Develops knowledge of products and technologies as well as continued knowledge of regulations and standards affecting IVDs and Biologics. Individual must have skills in basic data reduction, GMP documentation, basic computer and data management skills. Executes assigned tasks. Obtains and maintains certification in assigned job responsibilities and required training. Learns and understands GMP and safety procedures. Interacts on a daily basis with internal and external support groups to perform core skills. Participates in team activities and area metric tracking. Effectively uses the CAPA system and reviews or approves documents.Major responsibilitiesResponsible for implementing and maintaining the effectiveness of the quality system.Works in a collaborative environment with manufacturing and quality control to ensure understanding and compliance to quality system. Inspect/review Device history records for completeness and accuracy for all manufacturing including intermediates in-process and release testing as well as finishing (fill/label). Maintains expert knowledge of material/product traceability.Disposition material for use in manufacturing, product for sale and/or for clinical/investigational use. Able to make quick and compliant decisions regarding quality. Leads or participates in process improvement teams to optimize processes and procedures to ensure compliance. Recognizes deviation from normal operating procedures and recommends appropriate corrective actions.Responsible for review and approval of nonconformances/CAPA by verifying the appropriateness of the nonconformance, product safety and efficacy has been evaluated. Reviews the nonconformance meets the requirements listed within the established operating procedures. Participates in change control activities at a basic level.QualificationsSkills/Experience Requirements: Knowledge of the regulations and standards affecting IVDs and Biologics.Requires experience and training in GMP/ISO regulations, computer skills, data analysis, good verbal and written skills. Have organizational skills and ability to work efficiently and cooperatively in a team environment. Must have the ability to address multiple issues and make critical decisions in a fast paced environment. Computer Skills: Basic personal computing skills with experience to include word processing and spreadsheet applicationsAccountability:Performs assigned tasks with little supervision. Must have an attention to detail and ability to recognize errors in Device History Files. Able to coordinate and prioritize daily activities based on planning and production needs. Adherence to GMP/ISO guidelines is critical for production and device history records approved. Decisions made on a daily basis directly affect quality, compliance and efficiency of product delivery. Responsible for administrating nonconformances and ensuring the CAPA documents meet the standards for quality and remain in compliance. Individual will be directly responsible to ensure processes, procedures and documentation conform to all regulations. Takes initiative to be involved in decision making and provides recommends for improvements. Communication skills: Must have excellent communication skills to communicate effectively and lead the organization to make compliant decisions. Preferred experience includes basic laboratory and molecular biology knowledge, BS in Life Science or related field.Abbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.