|Interested? Email Us||Never Applied? Apply|
|Quality Assurance Specialist II|
|Hours:||40 Monday Friday 8AM to 5PM|
|Great opportunity in Camarillo CA|
Will be supporting other QA Specialists specifically with Customer Complaints, writing and managing CAPAsCARs. assisting our Material dept with Supplier Corrective Action SCAR and returns, should be familiar with cGMP Document Control, excellent writing skills and organization is required. Collaborate to support the Quality System. Recommend and implements changes to the existing quality system with regards to nonconforming product, correctivepreventive actions, document control, quality control inspections and product release, internal audits, validations and equipment calibration and maintenance programs. ResponsibilitiesResponsible for all activities involving quality assurance and compliance with applicable regulatory requirements Regulatory submissions and compliance with applicable national and international regulations.Conducts audits and reviewsanalyzes data and documentation. Initiate, investigate and complete nonconformance reports NCR. Participate in the MRB meetings. Includes ability to apply problem solving tools and methods to coordinate andor lead investigation teams.Participate in the management and execution of equipment, process and software validation.Manage the equipment calibration and maintenance program.Provide directions for all aspects of testing related to manufacturing.oFirst article inspectionsoIn-process release inspection.oFinal QC release of finished goods.oDocument review.Ensures that all inspections and procedures are properly completed and documented.Manages and control labeling.Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.Supports the environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures.Lead investigations of customer complaints.
HSGED with 3 to 5 yrs exp in a biotechnology or pharmaceutical manufacturing environment. Working knowledge Word Excel. Writing and managing CAPAsCARs, assisting dept with Supplier Correctiv action SCAR and returns, should be familiar with cGMp D
ERP system as SyteLine, SAP, Oracle preferredcGMP Document Control a plusBABS in a technical field