QA Specialist - Medical Device

Job Summary:

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.

• Reports to: QA Manager - Medical Device
• Location: Johnson City TN
• Hours: Monday-Friday 8AM-4PM

Responsibilities/Essential Duties:

* 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

Basic Qualifications:

* Minimum of 3-7 years' experience in the Medical Device, Pharmaceutical or regulated industry with prior experience in plant quality assurance.

* 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

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• 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

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.