VIVA USA Inc Quality Assurance Specialist II in Shrewsbury, Massachusetts
Req Ref No: SRMAQA254 Location: Shrewsbury, MA Duration: 6.0 months Description Job Description: What you’ll do Responsible for quality release of finished good products to packaging for shipment. Analyze and review manufacturing and test data in written or electronic form to verify accuracy and completeness necessary for the final release. This also includes subcontractor records when product is processed by a 3rd party (i.e. sterilizer records). Create tasks in electronic batch record data collection system to resolve product and process discrepancies. Issue Certificate of Quality for final product release when all release requirements have been verified and met. Provide consultation and guidance to other groups concerning documentation completeness, accuracy as well as related manufacturing quality management systems and processes. Collaborate timely with Cross functional teams to aid effective investigations & problems solving Interface with manufacturing to coordinate product release activities to best support production build and shipping schedules. Provide input for deviations and product concessions. Support Quality Assurance Engineers with deviation, investigation, and rework documentation review. Continually identify, recommend and implement process improvements with a lean and quality focus. Comply with EHS regulations & policies. Responding to routine quality related queries from other departments. Monitoring and aiding the implementation of continuous improvements and process changes to ensure these are implemented in compliance with GMP. Who you are : Demonstrated knowledge of Quality Management System Tools and continuous improvement methodologies. Demonstrated collaboration, negotiation & conflict resolution skills. Effective communication skills (written and oral). Ability to multi-task & handle tasks with competing priorities effectively. Technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures). Experience with generating, tracking and interpreting quality metrics. Demonstrate support to a positive quality culture 1-year experience in a medical device or pharmaceutical industry. 1-year experience with CAPA systems, including complaint handling. Thorough familiarity with cGMPs Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages. Quality Release : Key Skills/Job History: Detail oriented Prior product release experience Prior cGMP experience, preferably med device/pharma VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.