The QA (Quality Assurance) Operations Specialist, assists GMP (Good Manufacturing Practices) associates by providing first level, real-time Quality Assurance support for operational areas directly or indirectly involved in the execution of GMP-related activities.
This is a rotating day shift that will include weekend work.
Acts as the eyes and ears of QA within operational areas, helping to ensure that the facility is inspection-ready and GMP operations and documentation are in compliance
Review of Batch records(paper and electronic), logbooks, analytical testing, Quality Tag Outs, release of areas and equipment from product changeover and other GMP records as applicable
Make simple GMP decisions independently, work with senior staff and management with complex decision making
Coaching and mentoring associates with GMP tasks
Significant GMP knowledge & experience to be able to execute duties related to understanding of regulatory expectations, including their impact to quality operations.
Hard working, inquisitive, mentally-flexible and critical thinking skills. Ability to maintain a professional demeanor at all times.
A positive attitude and an ability to adapt to, and embrace changed conditions are a big plus.
Working knowledge of ICH guidelines and requirements
Must possess a working knowledge and understanding of critical process steps and parameters - e.g. Fermentation, Purification, quality control
Understands the concept of product clearance through process changeover
Knows the concept of deviation management and documentation
Understands the TrackWise, SAP, LIMS, SAP, Syncade and MicroSoft Office systems
Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows when to elevate