QA Principal Operations Specialist (Biotech)

 

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.

Key Responsibilities

• 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

Key Requirements

• 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