Quality Assurance Specialist - Medical Device

Revance•Johnson City, TN

5d•Onsite

About The Position

The QA Specialist is responsible for performing Quality compliance activities on the production floor and ensuring that all activities are in compliance with company and regulatory guidelines and procedures. In addition, the QA Specialist is also responsible for assisting in activities directly related to in-coming product/kitting release, batch record & procedure review.

Requirements

Minimum of 0-2 years’ experience in Quality Assurance, Manufacturing or regulated industry.
Demonstrated knowledge of cGMPs, other regulatory requirements for the manufacture, testing and release of Crown Aesthetics products.
Strong proficiency in Microsoft Office suite of products, (Word, Excel, PowerPoint)
Excellent verbal and written communication skills.
Excellent interpersonal, communications and organizational skills as well as the ability to work independently.
Must have the ability to stand for several hours, lift approximately 20lbs repetitively, unstack/restack pallets so to pull ANSI AQL samples.

Responsibilities

Perform audits/checks of incoming and in-process processes to include QA checks, line clearance activities, record review and signoff, label verification and reconciliation verification.
Perform Safe Launch and Safe Exit inspections for specified products.
Receipt & inspection of RMA material.
Approve minor deviations on the operation floor.
Review and approve executed batch records for completeness and accuracy for batch release.
Verify and ensure compliance with regulatory and company procedures and guidelines.
Assist with training floor personnel in GDocP.
Perform investigations as required.
Assist in other quality-related functions as requested.
Assist when applicable in kitting area, reporting to the area leadership team.
Time utilization to be shared with kitting department as needed.
Additional tasks as assigned by Quality Management and/or Kitting Leadership.