Job Title: QA Principal Operations Specialist - QAOTF
Summary: As a global leader in life sciences, my client is looking to add to their already extremely talented team of Quality Assurance specialists! Being a globally preferred partner to pharmaceutical, biotech and nutrition markets, focusing on enabling treatments that prevent illness and support a healthy lifestyle is a top priority for my client. Over the past 2 years, they have supported hundreds of preclinical and clinical small and large molecules, commercial small and large molecules and produced billions of capsules. My client is targeting someone who is looking to take their career into their own hands and be able to implement themselves into this very important work.
The QA Principal Operations Specialist - QAOTF will be responsible for:
- Perform daily rotation through GMP operational areas (GMP documentation, GMP work habits).
- Supporting GMP for manufacturing and QC (ie reviewing batch records).
- Document all items within QAOTF (Quality Assurance on the Floor) shift notes and provide follow-up for other shifts.
- Respond to QA Hotline calls in support of GMP operations and make most simple decisions independently (more complex to work with senior staff).
- Authorize placement and removal of Quality Tag Outs and release equipment from Product Changeover.
The QA Principal Operations Specialist - QAOTF should have the following requirements:
- High school diploma, Bachelor's Degree is preferred.
- At least 5 years of relevant experience.
- Have a solid understanding of cGMP and ICH guidelines and requirements.
- Have a working knowledge and understanding of critical process steps and parameters (ie Ferm, Purification, QC) and product clearance through process changeover.
- Previous experience working with TrackWise, SAP, LIMS is a plus.
- Able to identify abnormal or potentially impactful events which require escalation.
If this sounds like something you would be interested in, do not hesitate to apply!
