Job Title: QA Principal Operations Specialist
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).
- Provide GMP Guidance to manufacturing for both routine and non-routine issues,
- Provide some coaching and feedback for GMP and documentation behaviors, working with Manufacturing Management.
- Document all items within QAOTF shift notes, provide follow-up for other shifts as needed.
- Authorize placement and removal of Quality Tag Outs, release equipment from Product Changeover.
- Represent QA in meetings or on project teams as sole department representatives.
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!