· Administer the CAPA process and Change Control process for GBO NA, Inc.
· Provide support for CAPA for manufacturing process.
· Organize and administer CAPA meetings. Drive CAPA progress together with Vice President of Operations and QRM.
· Evaluate CAPA acceptance, root cause investigation and action items together with process owners and QRM.
· Provide support for process owners to ensure corrections are timely and supply chain functions are aligned with investigation progress and results.
· Participate in internal and intersite continuous improvement efforts by GBO project teams for CAPA and Change Control.
· Ensure all deviations from established procedures are appropriately documented and investigated for root cause. Requires direct input on the creation and effectiveness of corrective and preventive action plans.
· Assist with implementation and supporting on- going continuous improvements.
· Identify, develop and implement process robustness improvements through lean principals.
· Support site change controls as needed.
· Responsible for maintaining quality standards to meet FDA requirements, CFRs, and internal company policies with respect to the CAPA and Change Control processes.
· Responsible for investigating complex deviations and supporting the applicable CAPAs discovered in the upstream, downstream, manufacturing.
· Ensure our programs and manufacturing are in a state of control and processes feeding into the CAPA System are monitored.
· Maintain current procedures and execute quality functions within the Change Control/CAPA processes.
· Review change control information for accuracy and conformance to established guidelines and procedures.
· Other duties as assigned.
· Issues CAPAs.
· Represent QM for CAPA root cause investigation and effectiveness check.
· Write and read and delete access for electronic Quality folders and files.
· Write and read access for CAPA system, eQMS, and GBO internal system.
· Communicate with other departments and intersite on matters of Change Control and CAPA.
· Calls and organizes CAPA and Change Control meetings to drive the processes.
· College degree in life engineering or in science field, preferable Medical Technology
· Experience with either ISO 13485, or FDA GMP.
· Experience in Quality Assurance functions and Quality Compliance functions strongly preferred.
· Must have past experience in Quality and manufacturing process.
· Must have very good communication and medical writing skills.
· Proficient computer skills in Microsoft Excel and Word.
· Must pass pre-employment examination, qualification test.
Internal Number: 1399
About Greiner Bio-One
Located in Monroe, North Carolina, we provide product manufacturing, distribution logistics and production application support to our customers in Life Science and Clinical laboratories through our BioScience and PreAnyalitic business units.
The BioScience business operation of Greiner Bio-One offers products for the cultivation and analysis of cell and tissue cultures, micro-plates for high-throughput screening, allowing industry and research the most rapid and efficient drug screening, a complete line of dependable ready-to-use general lab-ware tools used in laboratories everywhere, and innovative bio-chip technologies for genotyping to detect gene defects and identify infectious agents.
The PreAnalytic business unit at Greiner Bio-One offers solutions for the collection of human samples under the VACUETTE brand name. Our products are designed in close cooperation with customers, and manufactured to meet the regulations of FDA QSR and cGMP, Health Canada and ISO 13485. Our products and the service we provide are geared toward the daily routine of laboratory medicine.
Greiner Bio-One, developed and sold the first plastic evacuation blood collection tube on the market to p...rovide Phlebotomy, Nursing, and Laboratory professionals with a new level of safety and product effectiveness that would help to eliminate the use of dangerous glass tubes. This level of service to the safety of the medical professional continues today in the products we bring to customers. Our products have extensive clinical backing along with educational programs and materials to help assure our customers that they will deliver the best possible results for their patients.