Software Quality Assurance Engineer

Job Description

The individual in this role will be responsible for Quality support related to primary and secondary distribution for commercial and EUA Drug products. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

Here's What You'll Do

Support the quality distribution of commercial and EUA Drug Product

Support oversight of the 3rd party logistics companies utilized for distribution

Partner with Supply Chain Logistics to support supply demand

Collaborate cross-functionally to ensure the team meets priorities and operational objectives

Support 3PL distribution metrics and report targeted metrics quarterly for Management Review

Participate in daily Allocation and Shipping meetings with Supply Chain

Participate in Quality Business Review meetings with 3PL

Develop and maintain Quality Agreements with suppliers and 3rd party logistics companies

Support Serialization implementation initiatives at 3PL

Participate and support relevant audits, as needed

Identify risks and communicate gaps for quality and GMP process/systems

Work closely with team members to recognize opportunities for improvement and help drive change

Ability to manage multiple projects in a fast-paced environment.

When necessary, author/update SOPs, etc.

Support commercial launch of Drug Product operations which may include but not limited to incoming inspection of material at the 3PL's.

Here's What You'll Bring To The Table

BS with at least 5 years of experience, or a Master's level degree with at least 3 years' experience in the pharmaceutical/biotech industry

Experience With Management Of Third-party Logistics Companies Required

Working knowledge of relevant FDA, EU, ICH guidelines and regulations

Experience with Excellent judgment and ability to communicate complex issues in an understandable way

Outstanding critical thinking and communication skills (verbal and written).

Ability to manage multiple projects in a fast-paced environment, project management experience a plus.

Ability to effectively collaborate in a dynamic, cross-functional matrix environment