QA Principal Operations Specialist (Nights)

United States, Portsmouth (New Hampshire)

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.

Will require shift work (including some weekends).

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
Reference: R23224