Allison Cottrell Email and Phone Number

• Packaging lead in successful new product launches and country expansions including coordinating with external suppliers to ensure timely delivery • Developed validation strategy and executed (OQ/PQ/PV) on primary and secondary packaging equipment • Led team responsible for successful qualification of blistering line increasing production flexibility• Reviewed and approved documentation for process controls, investigations, qualifications, and validations collaborating with external CMOs• Responsible for the implementation of small capital projects from the design stage through procurement and qualifications

• Effectively assisted in managing the successful and timely implementation of US and EU Serialization • Supported multiple CMOs in day-to-day life cycle management activities for over 20 SKUs • Coordinated efforts to implement new process improvements with our CMOs to standardize across products• Successfully collaborated cross functionally in the approval of production documentation meeting vital timelines• Implemented platforms with our CMOs that streamlined and streamlined communication, increasing productivity

• Assist key business units’ operations• Performing processing functions efficiently to achieve customer satisfaction• Operate in multiple computer systems simultaneously to complete tasks • Skilled in QC operations to confirm specific tasks are done correctly

• Worked with outside vendors to optimize more efficient packaging • Performed sealing on medical device packages in sterile cleanroom environment• Worked to verify packaging design to maintain integrity of product in package system.• Analyzed package specifications to trouble shoot best package for manufacturing on the line• Revision of packaging set up sheets and Bill of Materials• Cross-function work with multiple departments consisting of quality, regulatory, manufacturing and biomedical engineering