
Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
· Preform monthly/quarterly Fit and Finish inspection
· Perform all training requirements in a timely manner
· Support QAD with issue print
· Provide training, coaching and mentoring new employees or less experienced team members.
· Author and Approver access for eDMS.
· Assist with Rapids
· MBR/MFR reviewer
· Block/unblock materials
· Perform QA approval of suite and equipment changeover between client process.
· Perform autoclave logbook review and facilitate corrections.
· Observe active processing and available to manufacturing and PE for support.
· Maintain ISO 5 gowning qualification in addition to general site gowning certification for the manufacturing core.
· Escalate quality issues that may impact compliance, production schedules, or product safety.
· Spend majority of work hours on the manufacturing floor in production support areas. providing real-time quality oversight.
· Compliance walkthroughs.
· Trackwise access
· Identify and mitigate risks proactively to reduce deviations through active QA presence on the manufacturing floor.
· Lead and participate in Tier 1 QA Ops OTF huddle
· Support buffer/media preparation, equipment cleaning, and facility operations in classified manufacturing environments.
· Strong decision-making skills with the ability to make real-time quality decisions on the manufacturing floor.
· High attention to detail and commitment to data integrity.