QA Principal Operations Specialist
This is a rotating day shift that will include weekend work.
Level of role (I, II, III) will depend on skills and experience.
- 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
- High school or equivalent required, bachelor's degree preferred.
- 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