Dora Sanchez Email & Phone Number

Baltimore, Md, Us

Oklahoma City, Ok, Us

Quality Assurance Associate a member of the Quality Assurance Operations team reporting directly to the Quality Assurance Operations Manager. Maintain quality oversight of operational areas by working closely with operation’s personnel by performing inspection and release as well as assisting other departments with quality related processes and procedures as required. Strive for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.Perform product changeover / room clearance inspections; report results, including required corrective measures, to proper management.Assist in the development of new material specifications upon request; revise existing material specifications when changes are necessary.Release materials based on the results of Quality Control testing/inspections, according to material specification requirements. Review of Equipment Initiation Forms for accuracy and completion as well as assist the Facilities/Engineering department with creation of equipment tolerances.Review completed manufacturing buffer batch records for GMP/GDP deficiencies such as documentation errors, incomplete entries, deviations and other errors, prior to product/material release.Audit work-in-progress operations, assisting production personnel with correcting and/or recording quality and documentation issues as they arise.Reviews calibration and preventive/corrective maintenance records and other documentation as assigned for GMP/GDP deficiencies. Obtain Cell Lines when requested by Manufacturing, Program Management and Process DevelopmentWorks with the Operations team to ensure GMP/GDP practices are followed Record filing, retrieval, and maintenance.

Essential Functions of the Position•Devise corrective actions to correct and prevent failures (CAPAs)•Develop, prepare, and report technical information to management•Perform material transfers using a personal computer•Understand and comply with all safety procedures•Apply and comply with all aspects of the Quality System, Policies, Procedures, and safety guidelines•Understand and support inventory management•Understand and comply with all aspects of the distribution of a radioactive medical device ISO 13485•Perform radiological surveys and analyze results•Raw Material Testing: Incoming materials and radioactive package receipt, in process product testing and release•Review of device history records and batch record release•Perform basic equipment usage: constancy checks, scheduled verifications, calibration of equipment, verification of equipment calibration status, MCA testing•Perform area surveys and wipe tests•Perform ECA viable and non-viable particulate monitoring sampling and report completion•Understand basic production, packaging, and shipping processes for medical devices•Develop, prepare, and report technical information to management•Create and revise standard operating procedures, raw material test method, work instructions and other documents as required•Perform routine sampling of finished product per established guidelines (AQL)•Perform incoming inspection of raw materials, using established sampling guidelines•Use various measuring equipment to perform inspections•Initiate and review non-conforming material records. Includes contacting vendors as necessary to inform the vendor of material condition, conduct investigations, and determining material disposition.•Perform internal audits of facilities and manufacturing.•Perform instrument calibrations with the appropriate documentation.•Maintain the raw material tracking system.•Train all new hire employees•Assists manufacturing department with resolution of Quality issues

General Studies

Associate Of Arts And Sciences - Aas, Family Practice Nurse/Nursing