4 sr associate i quality assurance jobs found

Biogen Job Description This is a full time on-site position The Sr. Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The Sr. Associate I has an advanced understanding of QC Microbiology laboratory, testing, and Annex I requirements. Additionally, this individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate I provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures. This individual will assist with regulatory and third party audits, aid in...

Biogen Job Description This is a full time on site position (business hours, M-F) About the Role  The Quality Engineering (QE) Senior Associate I is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Senior Associate I will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality System cross-functionally.  What You'll Do  Review and approval of facility, utility, equipment, analytical instruments and automation lifecycle documentation including; User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews.  Review and approval of changes...

Biogen Job Description This is a full time, on site position with M-F business hours About This Role  Sr. Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility.  Specifically, this role will have primary quality oversight of the following activities: (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation.  It is expected that this role will report directly into a Sr. Manager.    WhatYou'llDo  Product Disposition:  Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution. Exceptions, Complaints and CAPA:  Assesses criticality of exceptions/investigations for product impact.  Performs thorough reviews of the...

Biogen Job Description The schedule for this position is M-F Business hours (full time, on-site) About This Role The Sr. Associate III of Quality Engineering and Quality Systems is responsible for understanding quality systems and maintaining oversight of GMP activities while supporting Automation, Engineering, Facilities, Manufacturing, and Quality Assurance/Quality Control stakeholders at the Biogen Research Triangle Park (RTP) Pharma facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement cross functionally and globally. Additionally, the Sr. Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture.  What You'll Do    Assist in the development and implementation of Global Quality Systems, leading site and global initiatives, provide oversight with respect to the proper administration and...