QA Specialist – Medical Device

Revance • Johnson City, TN

6d

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 20 lbs 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

Benefits

• Competitive Compensation including base salary and annual performance bonus
• Paid time off, holidays, and floating holidays that can be used for whatever you choose
• Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 101-250 employees