Quality Assurance Specialist - Medical Device

Revance; Johnson City (TN); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Competitive salary

Paid time off

Health benefits

401k match

Wellness programs

Job summary

Revance in Johnson City, TN is seeking a QA Specialist responsible for quality compliance on the production floor, ensuring activities align with company and regulatory guidelines. This role also supports in-coming product/kitting release, batch record and procedure review. Location: Johnson City, TN; Hours: Mon-Fri 8AM-4PM.

Responsibilities include audits, inspections, deviation approvals, batch release reviews, and training support. Reports to the QA Manager - Medical Device.

Qualifications

• 0–2 years experience in QA or regulated environment.
• Knowledge of cGMPs and regulatory requirements for manufacturing, testing and release.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Excellent verbal and written communication; strong interpersonal and organizational skills.
• Ability to stand for extended periods and lift up to 20 lbs as needed.

Responsibilities

• Perform QA checks on incoming and in-process materials and line clearance activities.
• Review batch records and procedures for completeness and accuracy prior to release.
• Approve minor deviations on the production floor.
• Assist with training floor personnel on GDocP.
• Conduct investigations and support quality-related activities as needed.

Skills

Quality Assurance

Regulatory Knowledge

MS Office

Communication Skills

Independent Work

Tools

Microsoft Office

Job description

Job Summary:

The QA Specialistis responsible forperforming Quality compliance activities on the production floor and ensuring that all activitiesare in compliance withcompany and regulatory guidelines and procedures. In addition, the QA Specialist is also responsible forassistingin activitiesdirectly relatedtoin-comingproduct/kitting release, batchrecord& procedurereview.

• Reports to: QA Manager - Medical Device
• Location: JohnsonCity 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, labelverificationand 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.
• Assistwith training floor personnel inGDocP.
• Perform investigations asrequired.
• Assistin other quality-related functions as requested.
• Assistwhen applicable in kitting area, reporting to the area leadership team
• Timeutilizationto be shared withkittingdepartment as needed.
• Additionaltasks as assigned by Quality Management and/or Kitting Leadership

Job Related Qualification/Skills

• Minimum of 0-2 years' experience in Quality Assurance,Manufacturingor regulated industry.
• Demonstratedknowledge ofcGMPs, other regulatory requirements for the manufacture,testingand release of Crown Aesthetics products.
• Strongproficiencyin 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 20lbsrepetitively, unstack/restack pallets so to pull ANSI AQL samples

Company Summary:

Crown is a proud member of theRevancePortfolio of skincare offerings.Revanceis 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,Revancemeets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

WhatRevanceinvests 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 demandsrequiredto 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 positionheld 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,experienceand viewpoints are valued.Revancedoes not discriminate in practices or employment opportunitieson the basis ofan 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.